FDA product code EGG: Attachment, Precision, All
EGG is the FDA product code for attachment, precision, all. It is a Class I device, regulated under 21 CFR 872.3165 and reviewed by the Dental panel. FDA has cleared 24 510(k) submissions under EGG, from 19 different applicants. The average 510(k) review took 106 days (median 68). FDA has posted 1 recall for EGG devices.
Classification
| Field | Value |
|---|---|
| Device name | Attachment, Precision, All |
| Device class | Class I |
| Regulation | 21 CFR 872.3165 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EGG clearance
Top EGG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zest Anchors, Inc. | 3 | 1994-04-07 |
| Metalor Dental USA Corp. | 2 | 1991-08-28 |
| Interpore Intl. | 2 | 1990-07-26 |
| Howmedica Corp. | 2 | 1979-10-22 |
| Steco-System-Technik GmbH & Cokg | 1 | 1999-09-03 |
14 more applicants have EGG clearances. See the full list in Caduvo.
Most recent EGG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990979 | Steco-System-Technik GmbH & Cokg | STECO-TITANMAGNETICS | 1999-09-03 | 164 |
| K950259 | Dr. Joseph E. Grasso, D.D.S. | COUPLING DEVICE FOR DENTAL PROSTHESIS | 1996-12-06 | 683 |
| K925700 | Zest Anchors, Inc. | ZEST ANCHOR ADVANCED GENERATION | 1994-04-07 | 511 |
| K915299 | Cogan Corp. | COGAN CORP KITS OF DENTAL HAND INSTRUMENTS | 1992-01-31 | 73 |
| K912435 | Metalor Dental USA Corp. | DENTAL CONNECTOR PRECISION ATTACHMENT | 1991-08-28 | 86 |
Recalls for EGG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-01-10.
Frequently asked questions
What is FDA product code EGG?
EGG is the FDA product code for attachment, precision, all. It is a Class I device, regulated under 21 CFR 872.3165 and reviewed by the Dental panel.
What device class is EGG?
Class I, regulation 21 CFR 872.3165. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EGG?
Across 24 cleared submissions the average was 106 days from receipt to decision (median 68).
Which companies have the most EGG clearances?
Zest Anchors, Inc. (3); Metalor Dental USA Corp. (2); Interpore Intl. (2); Howmedica Corp. (2); Steco-System-Technik GmbH & Cokg (1).
Have EGG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-01-10.
Next steps
- Run an FDA pathway report with predicate devices for product code EGG
- Run a recall and safety report across every EGG manufacturer
- Watch product code EGG 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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