FDA 510(k) Applications for Medical Device:
Coating, Filling Material, Resin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K223365 | Belport Company, Inc., Gingi-Pak |
4825 Calle Alto | Camarillo | CA | 93012 |
| K051999 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K030354 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K043168 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K030585 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K024046 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K021503 | BISCO, INC. |
1100 WEST IRVING PARK RD. | SCHAUMBURG | IL | 60193 |
| K240735 | Bredent GmbH & Co. KG |
Weissenhorner Str. 2 | Senden | 89250 | |
| K980298 | COSMEDENT, INC. |
5419 NORTH SHERIDAN RD. | CHICAGO | IL | 60640 |
| K011239 | COSMEDENT, INC. |
401 N. MICHIGAN AVE. | CHICAGO | IL | 60611 |
| K974494 | COSMEDENT, INC. |
5419 NORTH SHERIDAN RD. | CHICAGO | IL | 60640 |
| K070306 | DENTSPLY INTERNATIONAL, INC. |
SUSQUEHANNA COMMERCE CTR., 221 | YORK | PA | 17404 |
| K013179 | DMG USA, INC. |
414 SOUTH STATE ST. | DOVER | DE | 19901 |
| K162408 | DREVE DENTAMID GMBH |
MAX-PLANCK-STRASSE 31 | UNNA | 59423 | |
| K093019 | ENAMELITE LLC |
8708 CAPEHART COVE | AUSTIN | TX | 78733 |
| K133836 | GC AMERICA INC. |
3737 W. 127TH STREET | ALSIP | IL | 60803 |
| K052462 | GC AMERICA, INC. |
3737 WEST 127TH ST. | ALSIP | IL | 60803 |
| K250804 | ID KOREA CO., LTD. |
405, 150, Donggyecheon-ro | Dong-gu | 61436 | |
| K123761 | INNOVATION MEDITECH GMBH |
3150 E. BIRCH ST. | BREA | CA | 92821 |
| K030646 | KERR DENTAL MATERIALS CENTER |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K992067 | KERR DENTAL MATERIALS CENTER |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K063228 | KURARAY AMERICA, INC. |
600 LEXINGTON AVE. | NEW YORK | NY | 10022 |
| K080549 | PARKELL, INC. |
300 EXECUTIVE DR. | EDGEWOOD | NY | 11717 |
| K040599 | PARKELL, INC. |
155 SCHMITT BLVD. | FARMINGDALE | NY | 11735 |
| K073243 | RELIANCE ORTHODONTIC PRODUCTS, INC. |
1540 WEST THORNDALE AVE. | ITASCA | IL | 60143 |
| K984037 | ROYDENT DENTAL PRODUCTS, INC. |
1010 WEST HAMLIN RD. | ROCHESTER HILLS | MI | 48309 |
| K163568 | Shofu Dental Corporation |
1225 Stone Drive | San Marcos | CA | 92078 |
| K211854 | VITA Zahnfabrik GmbH H Rauter & Co |
Spitelgasse 3 | Bad Sackingen | D-79713 | |
| K082285 | VOCO GMBH |
ANTON-FLETTNER-STRASSE 1-3 | CUXHAVEN | D-27472 |
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