FDA 510(k) Applications for Medical Device:
Denture, Plastic, Teeth
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K101064 | BREDENT GMBH & CO.KG |
SCHWARZWALDSTRASSE 5 | TUTTLINGEN, BAWU | 78532 | |
| K122852 | CANDULOR USA, INC. |
175 PINEVIEW DRIVE | AMHERST | NY | 14228 |
| K060720 | CURATIVE, LLC |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K984128 | DAVIS SCHOTTLANDER & DAVIS, LTD. |
54 RIVERVIEW AVE. | TONAWANDA | NY | 14150-5260 |
| K984134 | DAVIS SCHOTTLANDER & DAVIS, LTD. |
54 RIVERVIEW AVE. | TONAWANDA | NY | 14150-5260 |
| K013824 | DENTAL MANUFACTURING S.P.A |
13 RED FOX LN. | LITTLETON | CO | 80127 |
| K022300 | DENTAL VIPI LTDA |
13 RED FOX LN. | LITTLETON | CO | 80127 |
| K092231 | GEBDI DENTAL-PRODUCTS GMBH |
INDUSTRIESTR 3A | ENGEN BAWU | 78234 | |
| K033628 | HERAEUS KULZER, INC. |
4315 SOUTH LAFAYETTE BLVD. | SOUTH BEND | IN | 46614-2517 |
| K060994 | HERAEUS KULZER, INC. |
4315 SOUTH LAFAYETTE BLVD. | SOUTH BEND | IN | 46614 |
| K011130 | HERAEUS KULZER, INC. |
99 BUSINESS PARK DR. | ARMONK | NY | 10504 |
| K101029 | HUGE DENTAL MATERIAL CO., LTD. |
3500 SOUTH DUPONT HIGHWAY | DOVER | DE | 19901 |
| K962456 | IVOCLAR NORTH AMERICA, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K120736 | IVOCLAR VIVADENT AG |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K060565 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K093331 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K132984 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K023035 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K000213 | J.F. JELENKO & CO. |
99 BUSINESS PARK DR. | ARMONK | NY | 10504 |
| K010160 | JENSEN INDUSTRIES, INC. |
50 STILLMAN RD. | NORTH HAVEN | CT | 06473 |
| K992854 | MASTERDENT LTDA. |
7150 N.W. 72 AVE. | MIAMI | FL | 33166 |
| K030588 | MERZ DENTAL GMBH |
100 MAIN ST. | CONCORD | MA | 01742 |
| K120404 | MERZ DENTAL GMBH |
5616 MARIOLA PL NE | ALBUQUERQUE | NM | 87111 |
| K122925 | NEW STETIC |
445 APOLLO BEACH BLVD | APOLLO BEACH | FL | 33572 |
| K022299 | RUTHIBRAS IMP. EXP. COM. DE MATERIAIS ODONTOLOGICO |
13 RED FOX LN. | LITTLETON | CO | 80127 |
| K121749 | SHOFU DENTAL CORPORATION |
1225 STONE DRIVE | SAN MARCOS | CA | 92078 |
| K113426 | SHOFU DENTAL CORPORATION |
1225 STONE DRIVE | SAN MARCOS | CA | 92078 |
| K070591 | UNION DENTAL S.A./UNIDESA.ODI |
PASEO DE LA ESTACION, 4 | TIELMES, MADRID | 28550 | |
| K060507 | VALPLAST INTL. CORP. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K122955 | WRIGHT HEALTH GROUP LTD. |
30 NORTHPORT ROAD | SOUND BEACH | NY | 11764 |
| K061337 | XPDENT CORP. |
12145 S.W. 131ST AVE. | MIAMI | FL | 33186 |
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