Syringe, Restorative And Impression Material
Regulation 872.4565
0510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in EID
| Company | 510(k)s | Recalls |
|---|---|---|
| Centrix, Inc. | 2 | 0 |
| Dentsply Intl. | 2 | 0 |
| Espe GmbH (Us) | 2 | 0 |
| Bio-Interfaces, Inc. | 1 | 0 |
| Caulk Co., Div. Dentsply | 1 | 0 |
| Cavitron Corp. | 1 | 0 |
| Coltene, Inc. | 1 | 0 |
| G-C Intl. Corp. | 1 | 0 |
| Lee Pharmaceuticals | 1 | 0 |
| Ultradent Products, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 12, 1994 | K941431 | BONE GRAFT DELIVERY SYRINGES Bio-Interfaces, Inc. | EID |
| Feb 25, 1992 | K913974 | ACCESS IMPRESSION BARREL Centrix, Inc. | EID |
| Sep 16, 1987 | K873153 | CAULK'S VPS CARTRIDGE SYSTEM Dentsply Intl. | EID |
| Jun 5, 1987 | K871937 | IMPRESSION SYRINGE Dentsply Intl. | EID |
| Oct 30, 1986 | K863998 | COLTENE JET-MIXER Coltene, Inc. | EID |
| Aug 23, 1985 | K853282 | CENTRIX RIBBON TUBES Centrix, Inc. | EID |
| Apr 29, 1985 | K851386 | UNITEK DISPOSABLE IMPRESSION SYRINGE Unitek Corp. | EID |
| Oct 6, 1981 | K812680 | G-C IMPRESSION SYRINGE G-C Intl. Corp. | EID |
| Sep 8, 1981 | K812277 | PRISMA-FIL COMPULES Caulk Co., Div. Dentsply | EID |
| Jul 28, 1981 | K811582 | THE PLACER Cavitron Corp. | EID |
| Dec 20, 1978 | K781977 | APPLICATOR, LEE IMPRESSION Lee Pharmaceuticals | EID |
| Jun 3, 1977 | K770931 | APPLIC SYSTEM APPLIER, ESPE Espe GmbH (Us) | EID |
| Jun 2, 1977 | K770941 | APPLIC SYSTEM ACTIVATOR, ESPE Espe GmbH (Us) | EID |
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