FDA Product Code
FDA Product Code EGD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.6890
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K020009 | BRACE EZE | Udent, Inc. | 2002-02-11 | Traditional | PDF ↗ |
| K945535 | GLENROE ORTHO-SIL | Glenroe Technologies | 1995-01-27 | Traditional | PDF ↗ |
| K924024 | ORTHO WAX | Heraeus Kulzer, Inc. | 1992-11-17 | Traditional | PDF ↗ |
| K923586 | BURNOUT MATERIAL | Dentsply Intl. | 1992-09-29 | Traditional | PDF ↗ |
| K914892 | SALIVA-STIM | Orion Diagnostica, Inc. | 1992-09-02 | Traditional | PDF ↗ |
| K922380 | BITE RIM WAX | Dentsply Intl. | 1992-06-16 | Traditional | PDF ↗ |
| K914513 | PALAVIT G | Heraeus Kulzer, Inc. | 1992-03-19 | Traditional | PDF ↗ |
| K910676 | INTRAORAL DENTAL WAX | Pemaco, Inc. | 1991-08-21 | Traditional | PDF ↗ |
| K904928 | PALAVIT GLC | Kulzer, Inc. | 1991-06-06 | Traditional | PDF ↗ |
| K895563 | PEMACO BITE WAX SHEETS | Pemaco, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K895564 | PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD | Pemaco, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K895561 | PEMACO 3000 INTRAORAL DENTAL WAX | Pemaco, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K895566 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT | Pemaco, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K895562 | PEMACO 2000 INTRAORAL DENTAL WAX | Pemaco, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K895565 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD | Pemaco, Inc. | 1989-10-24 | Traditional | PDF ↗ |
| K880607 | UTILITY WAX STRIPS, SPEARMINT | Columbus Dental Mfg. Co. | 1988-03-31 | Traditional | PDF ↗ |
| K880606 | UTILITY WAX STRIPS, CINNAMON | Columbus Dental Mfg. Co. | 1988-03-24 | Traditional | PDF ↗ |
| K863758 | ORTHO-BITE WAX WAFER | Columbus Dental Mfg. Co. | 1986-10-07 | Traditional | PDF ↗ |
| K854529 | INLAY WAX REGULAR | The Hygenic Corp. | 1986-03-10 | Traditional | PDF ↗ |
| K854530 | PREMIUM FLEXI-TOUGH | The Hygenic Corp. | 1986-03-04 | Traditional | PDF ↗ |
| K854527 | STICKY WAX | The Hygenic Corp. | 1986-03-04 | Traditional | PDF ↗ |
| K850915 | WAX BITE IMPRESSION WAFER | Toothprints, Inc. | 1985-04-16 | Traditional | PDF ↗ |
| K812804 | MODERN MATERIALS' INLAY CSTG. WAXES,A-C | Modern Materials | 1982-01-26 | Traditional | PDF ↗ |
| K812805 | STEELE'S ECON. PINK BASEPL. WAXES, I-III | Modern Materials | 1982-01-12 | Traditional | PDF ↗ |
| K801911 | HOWMEDICA BITE BLOCK | Howmedica Corp. | 1980-08-27 | Traditional | PDF ↗ |
Product code EGD · Class I · Dental. Data: openFDA.