Wax, Dental, Intraoral
Regulation 872.6890
0510(k)s in 12 months (25 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EGD
| Company | 510(k)s | Recalls |
|---|---|---|
| Pemaco, Inc. | 7 | 0 |
| Columbus Dental Mfg. Co. | 3 | 0 |
| The Hygenic Corp. | 3 | 0 |
| Dentsply Intl. | 2 | 0 |
| Heraeus Kulzer, Inc. | 2 | 0 |
| Modern Materials | 2 | 0 |
| Glenroe Technologies | 1 | 0 |
| Howmedica Corp. | 1 | 0 |
| Kulzer, Inc. | 1 | 0 |
| Orion Diagnostica, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 2002 | K020009 | BRACE EZE Udent, Inc. | EGD |
| Jan 27, 1995 | K945535 | GLENROE ORTHO-SIL Glenroe Technologies | EGD |
| Nov 17, 1992 | K924024 | ORTHO WAX Heraeus Kulzer, Inc. | EGD |
| Sep 29, 1992 | K923586 | BURNOUT MATERIAL Dentsply Intl. | EGD |
| Sep 2, 1992 | K914892 | SALIVA-STIM Orion Diagnostica, Inc., FI | EGD |
| Jun 16, 1992 | K922380 | BITE RIM WAX Dentsply Intl. | EGD |
| Mar 19, 1992 | K914513 | PALAVIT G Heraeus Kulzer, Inc. | EGD |
| Aug 21, 1991 | K910676 | INTRAORAL DENTAL WAX Pemaco, Inc. | EGD |
| Jun 6, 1991 | K904928 | PALAVIT GLC Kulzer, Inc. | EGD |
| Nov 6, 1989 | K895566 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT Pemaco, Inc. | EGD |
| Nov 6, 1989 | K895564 | PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD Pemaco, Inc. | EGD |
| Nov 6, 1989 | K895563 | PEMACO BITE WAX SHEETS Pemaco, Inc. | EGD |
| Nov 6, 1989 | K895562 | PEMACO 2000 INTRAORAL DENTAL WAX Pemaco, Inc. | EGD |
| Nov 6, 1989 | K895561 | PEMACO 3000 INTRAORAL DENTAL WAX Pemaco, Inc. | EGD |
| Oct 24, 1989 | K895565 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD Pemaco, Inc. | EGD |
| Mar 31, 1988 | K880607 | UTILITY WAX STRIPS, SPEARMINT Columbus Dental Mfg. Co. | EGD |
| Mar 24, 1988 | K880606 | UTILITY WAX STRIPS, CINNAMON Columbus Dental Mfg. Co. | EGD |
| Oct 7, 1986 | K863758 | ORTHO-BITE WAX WAFER Columbus Dental Mfg. Co. | EGD |
| Mar 10, 1986 | K854529 | INLAY WAX REGULAR The Hygenic Corp. | EGD |
| Mar 4, 1986 | K854530 | PREMIUM FLEXI-TOUGH The Hygenic Corp. | EGD |
| Mar 4, 1986 | K854527 | STICKY WAX The Hygenic Corp. | EGD |
| Apr 16, 1985 | K850915 | WAX BITE IMPRESSION WAFER Toothprints, Inc. | EGD |
| Jan 26, 1982 | K812804 | MODERN MATERIALS' INLAY CSTG. WAXES,A-C Modern Materials | EGD |
| Jan 12, 1982 | K812805 | STEELE'S ECON. PINK BASEPL. WAXES, I-III Modern Materials | EGD |
| Aug 27, 1980 | K801911 | HOWMEDICA BITE BLOCK Howmedica Corp. | EGD |
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