FDA 510(k) Applications for Medical Device:
Liner, Cavity, Calcium Hydroxide
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K230270 | 3M ESPE Dental Products |
2510 Conway Avenue | St. Paul | MN | 55144 |
| K143292 | Bisco Inc |
1100 West Irving Park Road | Schaumburg | IL | 60193 |
| K033521 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K180344 | Bisco, Inc. |
1100 West Irving Park Road | Schaumburg | IL | 60193 |
| K063237 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K001050 | CENTRIX, INC. |
770 RIVER RD. | SHELTON | CT | 06484-5458 |
| K021146 | CENTRIX, INC. |
770 RIVER RD. | SHELTON | CT | 06484-5458 |
| K060365 | IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. | AMHERST | NY | 14228 |
| K131068 | KURARAY NORITAKE DENTAL INC. |
OTE CENTER BLDG 7F | CHIYODA-KU | 100-0004 | |
| K122421 | KURARAY NORITAKE DENTAL INC. |
OTE CENTER BLDG 7F | CHIYODA-KU | 100-0004 | |
| K201799 | Maruchi |
2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan | Wonju-si | 26311 | |
| K022025 | MILTON HODOSH, M.D. |
243 ELWOOD AVE. | PROVIDENCE | RI | 02907 |
| K111668 | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
611 WEST 5TH STREET | AUSTIN | TX | 78701 |
| K191103 | Parkell, Inc. |
300 Executive Drive | Edgewood | NY | 11717 |
| K983477 | PHOENIX DENTAL, INC. |
3452 WEST THOMPSON RD. | FENTON | MI | 48430 |
| K212475 | Prevest Denpro Limited |
Export Promotion Industrial Park | Bari Brahmana | 181133 | |
| K113711 | PULPDENT CORPORATION |
80 Oakland St | WATERTOWN | MA | 02472 |
| K120003 | PULPDENT CORPORATION |
80 Oakland St | WATERTOWN | MA | 02472 |
| K973539 | ROEKO USA, INC. |
100 MAIN STREET,STE. 120 | CONCORD | MA | 01742 |
| K141047 | S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN |
ROBERT-BOSCH-STRASSE 2 | ELMSHORN, SCHLESWIG-HOLSTEIN | 25335 | |
| K202413 | S&C Polymer Silicon- und Composite Spezialitaten GmbH |
Robert-Bosch-Str. 2 | Elmshorn | 25335 | |
| K134022 | SPIDENT CO., LTD. |
2115 LINWOOD AVE | FORT LEE | NJ | 07024 |
| K010176 | STEPHEN M. KORAL, D.M.D. |
2006 BROADWAY | BOULDER | CO | 80302 |
| K150559 | SYBRON DENTAL SPECIALTIES |
1717 W. COLLINS AVENUE | ORANGE | CA | 92867 |
| K964191 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K012717 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K961708 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K970113 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K970114 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
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