FDA 510(k) Applications for Medical Device:
Crown And Bridge, Temporary, Resin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K001114 | 3M COMPANY |
3M CENTER | ST. PAUL | MN | 55144-1000 |
| K970168 | 3M COMPANY |
3M CENTER | ST. PAUL | MN | 55144-1000 |
| K151144 | 3M DEUTSCHLAND GMBH |
ESPE PLATZ | SEEFELD | 82234 | |
| K033022 | 3M ESPE AG DENTAL PRODUCTS |
ESPE PLATZ | SEEFELD, BAVARIA | D-82229 | |
| K073296 | 3M ESPE AG DENTAL PRODUCTS |
ESPE PLATZ | SEEFELD, BAVARIA | D-82229 | |
| K190217 | Aidite (Qinhuangdao) Technology Co., Ltd. |
No.9 Dushan Road,Economic and Technological Development Zone | Qinhuangdao | 066000 | |
| K223477 | Aidite (Qinhuangdao) Technology Co., Ltd. |
No.56 Tianchi Road, Economic and Technological | Qinhuangdao | 066004 | |
| K191843 | Amann Girrbach AG |
Herrschaftswiesen 1 | Koblach | 6842 | |
| K023079 | ANAXDENT GMBH |
1730 PENNSYLVANIA N.W. | WASHINGTON | DC | 20006 |
| K210817 | Arum Dentistry Co., Ltd |
44, Techno 8-ro, Yuseong-gu | Daejeon | 34028 | |
| K243370 | Asiga Pty Ltd |
Unit 2, 19-21 Bourke Road | Alexandria | 2015 | |
| K193553 | BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG |
Wilhelm-Herbst-Str. 1 | Bremen | 28359 | |
| K112186 | BIOLOREN SRL |
VIA ALESSANDRO VOLTA 59 | SARONNO | -- | |
| K073263 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K103514 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K182065 | Blue Dent Dental |
Rua: Joaquim Jorge Port 1272 | Pirassununga | 13636142 | |
| K052781 | BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT |
SCHWARZWALDSTR 11 | TUTTLINGEN | 78532 | |
| K101814 | CANDULOR USA, INC. |
7462 N. FIGUEROA STREET | LOS ANGELES | CA | 90041 |
| K123638 | CENDRES & METAUX SA |
RUE DE BOUJEAN 122 | BIEL/BIENNE | 2501 | |
| K041098 | COLTENE AG |
1349 LEXINGTON AVE. | NEW YORK | NY | 10128 |
| K980799 | COSMEDENT, INC. |
5419 NORTH SHERIDAN RD. | CHICAGO | IL | 60640 |
| K060881 | COSMEDENT, INC. |
401 NORTH MICHIGAN AVE. | CHICAGO | IL | 60611 |
| K102753 | DANVILLE MATERIALS, INC. |
3420 FOSTORIA WAY, SUITE A-200 | SAN RAMON | CA | 94583 |
| K102776 | DELTAMED GMBH |
RAIFFEISENSTR. 8A | FRIEDBERG | D-61169 | |
| K200039 | DeltaMed GmbH |
Raiffeisenstrasse 8a | Friedberg | 61169 | |
| K153490 | DENTAL DIREKT GMBH |
INDUSTRIEZENTRUM 106-108 | SPENGE | 32139 | |
| K000894 | DENTAL VENTURES OF AMERICA, INC. |
217 LEWIS CT. | CORONA | CA | 91720 |
| K152215 | DENTALPLUS GMBH |
KOHLGRUB 5 | SAMERBERG | 83122 | |
| K192806 | Dentca, Inc. |
357 Van Ness Way #250 | Torrance | CA | 90501 |
| K180657 | Dentis Co., Ltd. |
6, Yuram-ro, Dong-gu | Daegu | 41065 | |
| K231859 | DentsCare LTDA |
Av. Edgar Nelson Meister, 474 | Joinville | 89219-501 | |
| K061264 | DENTSPLY INTERNATIONAL, INC. |
221 W. PHILADELPHIA ST., SE 60 | YORK | PA | 17404 |
| K060293 | DENTSPLY INTERNATIONAL, INC. |
SUSQUEHANNA COMMERCE CTR., 221 | YORK | PA | 17404 |
| K080311 | DENTSPLY INTERNTIONAL |
221 W. PHILADELPHIA ST. STE.60 | YORK | PA | 17404 |
| K994012 | DETAX GMBH & CO. KG |
7707 E. 201 TERR | BELTON | MO | 64012 |
| K200273 | DETAX GmbH & Co.KG |
Carl-Zeiss-Strasse 4 | Ettlingen | 76275 | |
| K192158 | Diadent Group International |
16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu | Cheongji-si | 28161 | |
| K192022 | Diadent Group International |
16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu | Cheongju-si | 28161 | |
| K183337 | DMG Chemisch-Pharmazeutische Fabrik GmbH |
Elbgaustrasse 248 | Hamburg | 22547 | |
| K000951 | DMG USA, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K033227 | DMG USA, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K101710 | DMG USA, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K013674 | DMG USA, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K052800 | DMG USA, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K192830 | DMP Dental Industry S.A. |
Kalyvion Avenue | Markopoulo | 19003 | |
| K241226 | Dreve Denatmid GmbH |
Max-Planck-Strasse 31 | Nordrhein-Westfalen | ||
| K171729 | Dreve Dentamid GmbH |
Max-Planck-StraBe 31 | Unna | 59423 | |
| K191590 | Enlighten Materials Co., Ltd |
8F., NO.138, Sec.2, Jinshan S. Rd., Da-an Dist | Taipei | 10642 | |
| K211101 | EnvisionTEC GmbH |
Bruesseler Stra▀e 51 | Gladbeck | D-45968 | |
| K002364 | ESPE DENTAL AG |
ESPE PLATZ | SEEFELD, BAVARIA | D-82229 | |
| K243621 | Evoden Ind·stria ComΘrcio Importaτπo e Exportaτπo |
de Produtos Odontol≤gicos Ltda. | Pirassununga | 13633-428 | |
| K102917 | EXACTA DENTAL DIRECT, INC |
1151 HOPE STREET | STAMFORD | CT | 06907-1659 |
| K001884 | FLEXIBLE DIMENSIONS LLC. |
21911 ERIE LN. | LAKE FOREST | CA | 92630 |
| K240538 | Formlabs Ohio, Inc. |
27800 Lemoyne Rd | Millbury | OH | 43447 |
| K193113 | GC America Inc. |
3737 W. 127th Street | Alsip | IL | 60803 |
| K141562 | GC AMERICA, INC. |
3737 WEST 127TH ST. | ALSIP | IL | 60803 |
| K003817 | GC AMERICA, INC. |
3737 WEST 127TH ST. | ALSIP | IL | 60803 |
| K073106 | GC AMERICA, INC. |
3737 WEST 127TH ST. | ALSIP | IL | 60803 |
| K213643 | Guangzhou Heygears Imc. Inc |
Block B2, 501, 601, Enterprise Accelerator, Kaifa District | Guangzhou | 510700 | |
| K961198 | HARRY J. BOSWORTH CO. |
7227 NORTH HAMLIN AVE. | SKOKIE | IL | 60076 |
| K961199 | HARRY J. BOSWORTH CO. |
7227 NORTH HAMLIN AVE. | SKOKIE | IL | 60076 |
| K180578 | Harvest Dental Products, LLC |
905 Columbia Street | Brea | CA | 92821 |
| K132937 | HARVEST DENTAL PRODUCTS, LLC |
4281 EXPRESS LANE STE # L4094 | SARASOTA | FL | 34238 |
| K954976 | HEALEX PRODUCTS, INC. |
243 ELMWOOD AVE. | PROVIDENCE | RI | 02907 |
| K972198 | HEALTH-DENT INTL., INC. |
122-A KIRKLAND CIRCLE | OSWEGO | IL | 60543 |
| K201683 | Huge Dental Material Co., Ltd. |
Middle Shanhai Road | Rizhao City | 276800 | |
| K223706 | Huliang(shanghai) Bio-Tech Co., Ltd. |
Room 303, Building 5, Lane2388, Xiu Pu Road, Pudong | Shanghai | ||
| K033432 | IMTEC CORP. |
2401 NORTH COMMERCE | ARDMORE | OK | 73401 |
| K024282 | INOVATIV, LLC |
1155 TWIN HILLS DR. | JEFFERSON | OR | 97352 |
| K022030 | INOVATIV, LLC |
1155 TWIN HILLS DR. | JEFFERSON | OR | 97352 |
| K003377 | IVOCLAR NORTH AMERICA, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K003374 | IVOCLAR NORTH AMERICA, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K040951 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K013869 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K042820 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K093708 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K103379 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K153753 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DRIVE | AMHERST | NY | 14228 |
| K020157 | J. MORITA USA, INC. |
601 13TH STREET, N.W. | WASHINGTON | DC | 20005 |
| K991564 | J.F. JELENKO & CO., INC. |
99 BUSINESS PARK DR. | ARMONK | NY | 10504 |
| K063624 | KAVO AMERICA |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K001309 | KAY SEE DENTAL MFG. CO. |
124 EAST MISSOURI AVE. | KANSAS CITY | MO | 64106-1294 |
| K110747 | KERR CORPORATION |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K020178 | KERR DENTAL MATERIALS CENTER |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K000346 | KERR DENTAL MATERIALS CENTER |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K020092 | KERR DENTAL MATERIALS CENTER |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K122039 | KETTENBACH GMBH & CO KG |
IM HEERFELD 7 | ESCHENBURG | 35713 | |
| K122025 | KTK MEDICAL SUPPLIES GMBH |
INDUSTRIESTR. 16 | GERMERING | D-821110 | |
| K233868 | Kulzer, LLC |
4315 S. Lafayette Blvd | South Bend | IN | 46614 |
| K081705 | LANG DENTAL MFG. CO., INC. |
175 MESSNER DR. | WHEELING | IL | 60090-0969 |
| K083195 | LANG DENTAL MFG. CO., INC. |
175 MESSNER DR. | WHEELING | IL | 60090-0969 |
| K082700 | MAJOR PRODOTTI DENTARI S.P.A. |
VIA LUIGI EINAUDI 23 | MONACALIERI (TORINO) | I-10024 | |
| K080556 | MERZ DENTAL GMBH |
5616 MARIOLA PL NE | ALBUQUERQUE | NM | 87111 |
| K061809 | MERZ DENTAL GMBH |
4235 PROVIDENCE LN | TUCKER | GA | 30084 |
| K071548 | MERZ DENTAL GMBH |
5616 MARIOLA PL NE | ALBUQUERQUE | NM | 87111 |
| K190724 | Meta Biomed Co., Ltd |
270, Osong Saengmyeong 1-ro, | Cheongju-si | 28161 | |
| K061530 | META BIOMED CO., LTD. |
414-12 MOCHOONG-DONG | CHEONGJU CITY, CHUNGBUK | 361-140 | |
| K202965 | Mgnewton LTD. |
472, Hanjanggun-ro, Jain-myeon | Gyeongsan-si | 38552 | |
| K103474 | MICERIUM S.P.A. |
VIA MARCONI 83 | AVENGO | 16030 | |
| K093380 | MYCONE DENTAL SUPPLY CO., INC. |
616 HOLLYWOOD AVE. | CHERRY HILL | NJ | 08002 |
| K111666 | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
611 WEST 5TH STREET | AUSTIN | TX | 78701 |
| K192153 | New Stetic S.A. |
Carrera 53 No. 50 - 09 | Guarne - Antioquia | ||
| K110484 | NOVOCOL, INC. |
416 SOUTH TAYLOR AVE. | LOUISVILLE | CO | 80027 |
| K012360 | PARKELL, INC. |
155 SCHMITT BLVD. | FARMINGDALE | NY | 11735 |
| K991270 | PARKELL, INC. |
155 SCHMITT BLVD. | FARMINGDALE | NY | 11735 |
| K190930 | Parkell, Inc. |
300 Executive Drive | Edgewood | NY | 11717 |
| K021457 | PENTRON CORP. |
53 NORTH PLAINS INDUSTRIAL RD. | WALLINGFORD | CT | 06492 |
| K112967 | POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY |
VOLCJA DRAGA 42 | VOLCJA DRAGA | 5293 | |
| K201827 | Pro3dure Medical GmbH |
Am Burgberg 13 | Iserlohn | 58642 | |
| K081810 | PULPDENT CORPORATION |
80 OAKLAND ST. | WATERTOWN | MA | 02472 |
| K120784 | PULPDENT CORPORATION |
80 Oakland St | WATERTOWN | MA | 02472 |
| K172281 | Quest Dental USA Corp. |
17865 Sky Park Circle | Irvine | CA | 92614 |
| K201563 | Quest Dental USA Corp. |
17865 Sky Park Circle, Suite L1 | Irvine | CA | 92614 |
| K251271 | Rizhao HuGe Biomaterials Company, Ltd. |
No.2 North Zhaoyang Road, District of Donggang | Rizhao City | 276800 | |
| K141421 | RIZHAO HUGE DENTAL INDUSTRY CO., LTD |
ROOM 302, NO. 21 BLDG, KAIYU GARDEN, XISHAN SOUTH ROAD | WENZHOU, ZHEJIANG | 325000 | |
| K010012 | S & C POLYMER GMBH |
ROBERT-BOSCH-STRASSE 5 | ELMSHORN | D-25335 | |
| K133268 | SCHUTZ-DENTAL GMBH |
DIESELSTRASSE 5-6 | ROSBACH, HESSEN | DE 61191 | |
| K964691 | SCICAN |
1440 DON MILLS RD. | TORONTO, ONTARIO | M3B 3P9 | |
| K041886 | SCIENTIFIC PHARMACEUTICALS, INC. |
3221 PRODUCER WAY | POMONA | CA | 91768-3916 |
| K960938 | SILICON-UND COMPOSITE SPEZIALITATEN GMBH |
OFFENAUER WEG 19 | BOKHOLT-HANREDDER | D-25335 | |
| K214071 | SPIDENT CO., LTD. |
203 & 312, Korea Industrial Complex, 722 | Gojan-Dong, Namdong-Gu | 405-821 | |
| K242559 | SprintRay Inc. |
2710 Media Center Drive, Suite #100A | Los Angeles | CA | 90065 |
| K955331 | SYBRON DENTAL SPECIALTIES, INC. |
1332 SOUTH LONE HILL AVE. | GLENDORA | CA | 91740 |
| K031476 | SYBRON DENTAL SPECIALTIES, INC. |
1717 W. COLLINS AVE. | ORANGE | CA | 92867 |
| K013895 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K964981 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92667 |
| K963786 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K982459 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K243951 | Taiwan Dental Materials CO., LTD. |
11F., No. 136, Sec. 3, Zhongxiao E. Rd., DaÆan Dist. | Taipei | 106671 | |
| K142371 | TALLADIUM, INC. |
27360 WEST MUIRFIELD LN. | VALENCIA | CA | 91355 |
| K140894 | THE ARGEN CORPORATION |
5855 OBERLIN DRIVE | SAN DIEGO | CA | 92121 |
| K150432 | UNION DENTAL S.A. |
PASEO DE LA ESTACION, 4. | TIELMES | 28550 | |
| K102341 | VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE |
5401 S. COTTONWOOD COURT | GREENWOOD VILLAGE | CO | 80121 |
| K070991 | VITA |
3150 E.BIRCH ST | BREA | CA | 92821 |
| K040769 | VOCO GMBH |
19379 BLUE LAKE LOOP | BEND | OR | 97702 |
| K120779 | VOCO GMBH |
ANTON-FLETTNER-STRASSE 1-3 | CUXHAVEN | D-27472 | |
| K201090 | VOCO GmbH |
Anton-Flettner-Str. 1-3 | Cuxhaven | 27472 | |
| K091894 | VOCO GMBH |
ANTON-FLETTNER-STRASSE 1-3 | CUXHAVEN | D-27472 | |
| K960122 | WALLACE A. ERICKSON & CO. |
1920 NORTH CLYBOURN AVE. | CHICAGO | IL | 60614 |
| K152443 | WHIP MIX CORPORATION |
361 FARMINGTON AVENUE | LOUISVILLE | KY | 40217 |
| K131664 | WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG |
361 FARMINGTON AVENUE | LOUISVILLE | KY | 40217 |
| K080182 | WIELAND DENTAL + TECHNIK GMBH & CO. KG |
SCHWENNINGER STRABE 13 | PFORZHEIM | D-75179 | |
| K151764 | YAMAHACHI DENTAL PRODUCTS USA, INC. |
160 PARK AVENUE | NUTLEY | NJ | 07110 |
| K191619 | Zest Anchors, LLC |
2875 Loker Avenue East | Carlsbad | CA | 92010 |
| K180562 | Zirkonzahn Gmbh |
Gewerbegebiet - Zona Industriale An der Ahr 7 | Gais | 39030 | |
| K200676 | Zirkonzahn srl |
Via An der Ahr 7 | Gais | 39030 |
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