FDA 510(k) Applications for Medical Device:
Mouthguard, Prescription
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K151933 | 12TH MAN TECHNOLOGIES, INC. |
7245 GARDEN GROVE BLVD., | GARDEN GROVE | CA | 92841 |
| K202465 | 3D Diagnostix Inc. |
24 Denby Road | Allston | MA | 02134 |
| K161884 | 3Shape A/S |
Holmens Kanal 7 | Copenhagen | 1060 | |
| K182820 | Advanced Facialdontics LLC |
325 Lake Ave. Unit 759 | St. James | NY | 11780 |
| K061122 | ALPINE ORAL CARE, LLC |
4003 LEELAND | HOUSTON | TX | 77003 |
| K191836 | Amann Girrbach AG |
Herrschaftswiesen 1 | Koblach | 6842 | |
| K210011 | Ampower Dental Laboratories, LLC |
3423 Investment Blvd Suite 11 Hayward | Hayward | CA | 94545 |
| K090472 | ARCHTEK, INC. |
1705 SOUTH CAPITOL OF TEXAS HW | AUSTIN | TX | 78746 |
| K091880 | ASCENTIA HEALTH INCORPORATED |
8473 RIPPLED CREEK COURT | SPRINGFIELD | VA | 22153 |
| K111828 | ASTRON DENTAL CORPORATION |
815 OAKWOOD RD. UNIT G | LAKE ZURICH | IL | 60047 |
| K231793 | Belport Company, Inc., Gingi-Pak |
4825 Calle Alto | Camarillo | CA | 93012 |
| K241311 | Bernhard F÷rster GmbH |
Westliche Karl-Friedrich-Strasse 151 | Pforzheim | 75172 | |
| K181361 | Brux Night Guard |
8201 Canoga Ave. #9066 | Canoga Park | CA | 91309 |
| K030832 | COSMEDENT, INC. |
401 NORTH MICHIGAN AVE. | CHICAGO | IL | 60611 |
| K955701 | CYCURA CORP. |
P.O. BOX 364 | ROCKLIN | CA | 95677 |
| K024261 | DENTAL CONCEPTS LLC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K053580 | DENTAL CONCEPTS LLC. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K063483 | DENTEK ORAL CARE, INC. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K222604 | dentona AG |
Otto-Hahn-Strasse 27 | Dortmund | 44227 | |
| K072522 | DENTSPLY INTERNATIONAL, INC. |
221 W. PHILADELPHIA ST. | YORK | PA | 17404 |
| K062828 | DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER | YORK | PA | 17404 |
| K232448 | Detax GmbH |
Carl-Zeiss-Strasse 4 | Ettingen | D-76275 | |
| K210940 | DMG Digital Enterprises SE |
Elbgaustrasse 248 | Hamburg | 22547 | |
| K112868 | DREAMGARD, INC. |
1601 K STREET, NW | WASHINGTON | DC | 20006 |
| K201173 | EnvisionTEC GmbH |
Brusseler Strabe 51 | Gladbeck | D-45968 | |
| K220894 | EnvisionTEC GmbH |
Brusseler Stra▀e 51 | Gladbeck | D-45968 | |
| K200125 | Erkodent Erich Kopp GmbH |
Siemensstrasse 3 | Pfalzgrafenweiler | 72285 | |
| K222061 | Formlabs Ohio, Inc. |
27800 Lemoyne Rd | Millbury | OH | 43447 |
| K232087 | Formlabs Ohio, Inc. |
27800 Lemoyne Rd | Millbury | OH | 43447 |
| K222845 | Frey Oral Technologies LLC |
433 North Camden Drive, Suite 1070 | Beverly Hills | CA | 90210 |
| K121365 | GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP |
2181 DUPONT DR. | IRVINE | CA | 92612 |
| K082723 | GRIND GUARD TECHNOLOGIES, LLC |
342 E. MAIN STREET | LEOLA | PA | 17540 |
| K243516 | GrindGuard Inc |
155 Jackson St | San Francisco | CA | 94111 |
| K981546 | HERAEUS KULZER, INC. |
4315 SOUTH LAFAYETTE BLVD. | SOUTH BEND | IN | 46614-2517 |
| K230237 | Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. |
3-3, No. 10, Tiangui Road, Mudong Town, Banan District | Chongqing | 401338 | |
| K014079 | INVENTIVE RESOURCES, INC. |
200 GREGORY LN. | PLEASANT HILL | CA | 94523-3389 |
| K980953 | JEROME M. SIMON |
1500 SUMMER ST. | STAMFORD | CT | 06905 |
| K183598 | Keystone Industries |
480 S. Democrat Rd | Gibbstown | NJ | 08027 |
| K241369 | Lijia LLC |
1520 Brookhollow Dr | Santa Ana | CA | 92705 |
| K230592 | LuxCreo Inc. |
940 Old County Road | Belmont | CA | 94002 |
| K040315 | MCI-MYOHEALTH SYSTEMS |
26552 TAMPICO PLACE | MISSION VIEJO | CA | 92691 |
| K230495 | Meris Investment Group |
1145 Quentin Ave S | Lakeland | MN | 55043 |
| K134015 | MERZ DENTAL GMBH |
5616 MARIOLA PL NE | ALBUQUERQUE | NM | 87111 |
| K111066 | MIGRATHERAPY LLC |
4403 MANCHESTER AVENUE, | ENCINITAS | CA | 92024 |
| K203000 | Mycone Dental Supply Co. Inc. (DBA Keystone Industries) |
480 S. Democrat Road | Gibbstown | NJ | 08027 |
| K230548 | Myohealth Technologies, LLC |
13765 NW Cornell Rd Suite 150 | Portland | OR | 97229 |
| K203596 | Panthera Dental Inc. |
9105, rue John-Simons | Quebec | G2B 0S6 | |
| K022809 | POWER PRODUCTS, INC.-SPLINTEK |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K071404 | POWER PRODUCTS, INC.-SPLINTEK |
9755 RIDGE DRIVE | LENEXA | KS | 66219 |
| K214102 | Prismatik Dentalcraft, Inc. |
2144 Michelson Drive | Irvine | CA | 92612 |
| K223798 | Prismatik Dentalcraft, Inc. |
2144 Michelson Drive | Irvine | CA | 92612 |
| K231775 | Pro3dure Medical |
Am Burgberg 13 | Iserlohn | 58642 | |
| K211415 | Pro3dure Medical GmbH |
Am Burgberg 13 | Iserlohn | 58642 | |
| K212017 | Pro3dure Medical GmbH |
Am Burgberg 13 | Iserlohn | 58642 | |
| K110468 | RANDMARK DENTAL PRODUCTS, LLC |
9109 COPENHAVER DRIVE | POTOMAC | MD | 20854 |
| K143623 | RESMED SAS |
292, ALLEE JACQUES, MONOD | SAINT-PRIEST CEDEX | 69791 | |
| K022627 | SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP |
1801 K ST. NW | WASHINGTON | DC | 20006 |
| K143655 | SICAT GMBH & CO. KG |
BRUNNENALLEE 6 | BONN | 53177 | |
| K240463 | Slow Wave Inc. |
26100 Countryside Dr. | Spicewood | TX | 78669 |
| K123161 | SMARTGUARD, INC. |
601 BRICKELL KEY DRIVE | MIAMI | FL | 33131 |
| K102909 | SOMNOMED INC |
7460 WARREN PARKWAY | FRISCO | TX | 75034 |
| K212767 | Splintek, Inc. |
15555 West 108th Street | Lenexa | KS | 66219 |
| K212448 | SprintRay Inc |
2705 Media Center Drive, Suite 100A | Los Angeles | CA | 90065 |
| K170985 | TMJ Services, LLC |
2009 Mallory Lane | Franklin | TN | 37067 |
| K221022 | Vertex-Dental BV |
Centurionbaan 190 | Soesterberg | 3769AV | |
| K201091 | VOCO GmbH |
Anton-Flettner-Str. 1-3 | Cuxhaven | 27472 | |
| K241729 | Whip Mix Corporation |
361 Farmington Avenue | Louisville | KY | 40209 |
| K190107 | Whip Mix Corporation |
361 Farmington Avenue | Louisville | KY | 40217 |
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