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FDA 510(k) Applications for Medical Device:
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| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K050318 | BIOENVELOP AGRO, INC. |
1129 BLOOMFIELD AVENUE | WEST CALDWELL | NJ | 07006 |
| K010935 | BRITESMILE, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K040797 | BRITESMILE, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K151945 | DENALI CORPORATION |
134 OLD WASHINGTON STREET | HANOVER | MA | 02339 |
| K043301 | GC AMERICA, INC. |
3737 WEST 127TH ST. | ALSIP | IL | 60803 |
| K972775 | INTERDENT, INC. |
2230 SOUTH BARRINGTON | LOS ANGELES | CA | 90064 |
| K983227 | KREATIV, INC. |
9025 BALBOA AVE. | SAN DIEGO | CA | 92123 |
| K182118 | Mavrik Dental Systems Ltd |
25 Ha Haroshet Street, 6th floor | Raanana | ||
| K021524 | PRIME DENTAL MANUFACTURING, INC. |
3735 WEST BELMONT AVE. | CHICAGO | IL | 60618 |
| K022522 | PULPDENT CORPORATION |
80 OAKLAND ST. | WATERTOWN | MA | 02472 |
| K021613 | SHOFU DENTAL CORP. |
1225 STONE DR. | SAN MARCOS | CA | 92078 |
| K954990 | THE HYGENIC CORP. |
1245 HOME AVE. | AKRON | OH | 44310 |
| K961472 | WORLDWIDE DENTAL, INC. |
100 MAIN ST. | CONCORD | MA | 01742 |