EGD · Wax, Dental, Intraoral
Dental · 21 CFR 872.6890 · Class 1
Overview
| Product Code | EGD |
|---|---|
| Device Name | Wax, Dental, Intraoral |
| Regulation | 21 CFR 872.6890 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K020009 | BRACE EZE | Udent, Inc. | Feb 11, 2002 | SESE |
| K945535 | GLENROE ORTHO-SIL | Glenroe Technologies | Jan 27, 1995 | SESE |
| K924024 | ORTHO WAX | Heraeus Kulzer, Inc. | Nov 17, 1992 | SESE |
| K923586 | BURNOUT MATERIAL | Dentsply Intl. | Sep 29, 1992 | SESE |
| K914892 | SALIVA-STIM | Orion Diagnostica, Inc. | Sep 2, 1992 | SESE |
| K922380 | BITE RIM WAX | Dentsply Intl. | Jun 16, 1992 | SESE |
| K914513 | PALAVIT G | Heraeus Kulzer, Inc. | Mar 19, 1992 | SESE |
| K910676 | INTRAORAL DENTAL WAX | Pemaco, Inc. | Aug 21, 1991 | SESE |
| K904928 | PALAVIT GLC | Kulzer, Inc. | Jun 6, 1991 | SESE |
| K895566 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT | Pemaco, Inc. | Nov 6, 1989 | SESE |
| K895564 | PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD | Pemaco, Inc. | Nov 6, 1989 | SESE |
| K895563 | PEMACO BITE WAX SHEETS | Pemaco, Inc. | Nov 6, 1989 | SESE |
| K895562 | PEMACO 2000 INTRAORAL DENTAL WAX | Pemaco, Inc. | Nov 6, 1989 | SESE |
| K895561 | PEMACO 3000 INTRAORAL DENTAL WAX | Pemaco, Inc. | Nov 6, 1989 | SESE |
| K895565 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD | Pemaco, Inc. | Oct 24, 1989 | SESE |
| K880607 | UTILITY WAX STRIPS, SPEARMINT | Columbus Dental Mfg. Co. | Mar 31, 1988 | SESE |
| K880606 | UTILITY WAX STRIPS, CINNAMON | Columbus Dental Mfg. Co. | Mar 24, 1988 | SESE |
| K863758 | ORTHO-BITE WAX WAFER | Columbus Dental Mfg. Co. | Oct 7, 1986 | SESE |
| K854529 | INLAY WAX REGULAR | The Hygenic Corp. | Mar 10, 1986 | SESE |
| K854530 | PREMIUM FLEXI-TOUGH | The Hygenic Corp. | Mar 4, 1986 | SESE |
Top Applicants
- Pemaco, Inc. — 7 clearances
- The Hygenic Corp. — 3 clearances
- Columbus Dental Mfg. Co. — 3 clearances
- Modern Materials — 2 clearances
- Heraeus Kulzer, Inc. — 2 clearances
