FDA product code EGD: Wax, Dental, Intraoral
EGD is the FDA product code for wax, dental, intraoral. It is a Class I device, regulated under 21 CFR 872.6890 and reviewed by the Dental panel. FDA has cleared 25 510(k) submissions under EGD, from 12 different applicants. The average 510(k) review took 90 days (median 61).
Classification
| Field | Value |
|---|---|
| Device name | Wax, Dental, Intraoral |
| Device class | Class I |
| Regulation | 21 CFR 872.6890 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EGD clearance
Top EGD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pemaco, Inc. | 7 | 1991-08-21 |
| Columbus Dental Mfg. Co. | 3 | 1988-03-31 |
| The Hygenic Corp. | 3 | 1986-03-10 |
| Heraeus Kulzer, Inc. | 2 | 1992-11-17 |
| Dentsply Intl. | 2 | 1992-09-29 |
7 more applicants have EGD clearances. See the full list in Caduvo.
Most recent EGD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020009 | Udent, Inc. | BRACE EZE | 2002-02-11 | 40 |
| K945535 | Glenroe Technologies | GLENROE ORTHO-SIL | 1995-01-27 | 74 |
| K924024 | Heraeus Kulzer, Inc. | ORTHO WAX | 1992-11-17 | 98 |
| K923586 | Dentsply Intl. | BURNOUT MATERIAL | 1992-09-29 | 71 |
| K914892 | Orion Diagnostica, Inc. | SALIVA-STIM | 1992-09-02 | 307 |
Recalls for EGD devices
openFDA lists no recalls for product code EGD.
Frequently asked questions
What is FDA product code EGD?
EGD is the FDA product code for wax, dental, intraoral. It is a Class I device, regulated under 21 CFR 872.6890 and reviewed by the Dental panel.
What device class is EGD?
Class I, regulation 21 CFR 872.6890. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EGD?
Across 25 cleared submissions the average was 90 days from receipt to decision (median 61).
Which companies have the most EGD clearances?
Pemaco, Inc. (7); Columbus Dental Mfg. Co. (3); The Hygenic Corp. (3); Heraeus Kulzer, Inc. (2); Dentsply Intl. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code EGD
- Run a recall and safety report across every EGD manufacturer
- Watch product code EGD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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