FDA 510(k) Applications for Medical Device:
Sealant, Pit And Fissure, And Conditioner
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K992326 | 3M COMPANY |
3M CENTER | ST. PAUL | MN | 55144-1000 |
| K091632 | 3M COMPANY |
3M CENTER,BLDG. 275-2W-08 | ST. PAUL | MN | 55144-1000 |
| K991099 | AMERICAN DENTAL PRODUCTS, INC. |
603-B COUNTRY CLUB DR. | BENSENVILLE | IL | 60106-1329 |
| K190998 | Apex Dental Materials, Inc. |
330 Telser Road | Lake Zurich | IL | 60047 |
| K162598 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K991902 | BOSWORTH CO. |
7227 NORTH HAMLIN AVE. | SKOKIE | IL | 60076-3999 |
| K053089 | CAO GROUP, INC. |
8683 SOUTH 700 WEST | SANDY | UT | 84070 |
| K062886 | CAO GROUP, INC. |
4628 WEST SKYHAWK DRIVE | WEST JORDAN | UT | 84084 |
| K961190 | CENTRIX, INC. |
770 RIVER RD. | SHELTON | CT | 06484-5458 |
| K093059 | CLASSONE ORTHODONTICS, INC. |
5064 50TH ST. | LUBBOCK | TX | 79414 |
| K042823 | COSMEDENT, INC. |
401 NORTH MICHIGAN AVE. | CHICAGO | IL | 60611 |
| K071158 | DENALI CORPORATION |
134 OLD WASHINGTON STREET | HANOVER | MA | 02339 |
| K083473 | DENALI R&D CORPORATION |
134 OLD WASHINGTON STREET | HANOVER | MA | 02339 |
| K050959 | DENTSPLY INTERNATIONAL |
221 W. PHILADELPHIA ST. | YORK | PA | 17404 |
| K982564 | DENTSPLY INTL. |
570 WEST COLLEGE AVE. | YORK | PA | 17405-0872 |
| K991909 | DENTSPLY INTL. |
570 WEST COLLEGE AVE. | YORK | PA | 17405-0872 |
| K992516 | DENTSPLY INTL. |
570 WEST COLLEGE AVE. | YORK | PA | 17405-0872 |
| K992519 | DENTSPLY INTL. |
570 WEST COLLEGE AVE. | YORK | PA | 17405-0872 |
| K992518 | DENTSPLY INTL. |
570 WEST COLLEGE AVE. | YORK | PA | 17405-0872 |
| K100062 | DMG USA, INC. |
23 FRANK MOSSBERG DRIVE | ATTLEBORO | MA | 02703 |
| K081493 | DMG USA, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K102252 | DMP LTD |
KALYVION AVENUE | MARKOPOULO, ATTIKI | 19003 | |
| K954867 | FOREMOST DENTAL MFG., INC. |
242 SOUTH DEAN ST. | ENGLEWOOD | NJ | 07631 |
| K012542 | GC AMERICA, INC. |
3737 WEST 127TH ST. | ALSIP | IL | 60803 |
| K033751 | HARRY J. BOSWORTH CO. |
7227 NORTH HAMLIN AVE. | SKOKIE | IL | 60076 |
| K051224 | HARRY J. BOSWORTH CO. |
7227 NORTH HAMLIN AVE. | SKOKIE | IL | 60076 |
| K031811 | HARRY J. BOSWORTH CO. |
7227 NORTH HAMLIN AVE. | SKOKIE | IL | 60076 |
| K091635 | HERAEUS KULZER, LLC |
300 HERAEUS WAY | SOUTH BEND | IN | 46614 |
| K122521 | ITENA CLINICAL |
500 BOUL CARTIER WEST | LAVAL | H7V 5B7 | |
| K011491 | IVOCLAR NORTH AMERICA, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K190339 | Ivoclar Vivadent, AG |
Bendererstrasse 2 | Schaan | FL-9494 | |
| K990306 | KAY SEE DENTAL MFG. CO. |
124 EAST MISSOURI AVE. | KANSAS CITY | MO | 64106-1294 |
| K011908 | KERR DENTAL MATERIALS CENTER |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K965091 | KURARAY COMPANY, LTD. |
200 PARK AVE. | NEW YORK | NY | 10166-3098 |
| K012742 | KURARAY MEDICAL INC. |
30TH FL. METLIFE BUILDING | NEW YORK | NY | 10166 |
| K973541 | MEDENTAL INTL. |
1246 CLEAR CREEK RD. | EVERGREEN | CO | 80434 |
| K171330 | Nanova Biomaterials Inc |
3806 Mojave Ct | Columbia | MO | 65202 |
| K110058 | NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC |
416 S. TAYLOR AVE | LOUISVILLE | CO | 80027 |
| K141717 | PAC-DENT INTERNATIONAL, INC. |
21038 Commerce Pointe Dr. | Walnut | CA | 91789 |
| K161580 | PREMIER DENTAL COMPANY PRODUCTS |
1710 ROMANO DRIVE | PLYMOUTH MEETING | PA | 19462 |
| K061997 | PREMIER DENTAL PRODUCTS CO. |
1710 ROMANO DR. | PLYMOUTH MEETING | PA | 19462 |
| K012761 | PRIME DENTAL MANUFACTURING, INC. |
3735 WEST BELMONT AVE. | CHICAGO | IL | 60618 |
| K963921 | PULPDENT CORP. |
80 OAKLAND ST. | WATERTOWN | MA | 02472 |
| K020287 | PULPDENT CORPORATION |
80 OAKLAND ST. | WATERTOWN | MA | 02472 |
| K052281 | PULPDENT CORPORATION |
80 OAKLAND ST. | WATERTOWN | MA | 02472 |
| K113818 | PULPDENT CORPORATION |
80 Oakland St | WATERTOWN | MA | 02472 |
| K172169 | Pulpdent Corporation |
80 Oakland Street | Watertown | MA | 02472 |
| K011822 | RITE-DENT MANUFACTURING CORP. |
1056 EAST 33RD ST. | HIALEAH | FL | 33013-3526 |
| K230455 | Rizhao HuGe Biomaterials Company, Ltd. |
No.2 North Zhaoyang Road, District of Donggang | Rizhao City | 276800 | |
| K111782 | SHOFU DENTAL CORPORATION |
1225 STONE DRIVE | SAN MARCOS | CA | 92078 |
| K990650 | SOUTHERN DENTAL INDUSTRIES, INC. |
246 FIRST ST., SUITE 204 | SAN FRANCISCO | CA | 94105 |
| K050871 | SOUTHERN DENTAL INDUSTRIES, INC. |
5 BRUNSDON ST 3125 | BAYSWATER VI 3125 | ||
| K954827 | SYBRON DENTAL SPECIALTIES, INC. |
1332 SOUTH LONE HILL AVE. | GLENDORA | CA | 91740 |
| K232498 | Ultradent Product, Inc. |
505 West Ultradent Drive (10200 South) | South Jordan | UT | 84095 |
| K101245 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K112517 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K993846 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K103121 | VERICOM CO., LTD. |
#606,5TH DONGYOUNG VENTURESTEL | ANYANG-SI, GYEONGGI-DO | 430-817 | |
| K021844 | VOCO GMBH |
19379 BLUE LAKE LOOP | BEND | OR | 97702 |
| K061823 | VOCO GMBH |
ANTON-FLETTNER-STRASSE 1-3 | CUXHAVEN | D-27472 | |
| K021842 | VOCO GMBH |
19379 BLUE LAKE LOOP | BEND | OR | 97702 |
| K130485 | VOCO GMBH |
ANTON-FLETTNER-STRASSE 1-3 | CUXHAVEN | D-27472 | |
| K062344 | VOCO GMBH |
ANTON-FLETTNER-STRASSE 1-3 | CUXHAVEN | D-27472 |
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