FDA product code ELZ: Crown, Preformed
ELZ is the FDA product code for crown, preformed. It is a Class I device, regulated under 21 CFR 872.3330 and reviewed by the Dental panel. FDA has cleared 9 510(k) submissions under ELZ, from 7 different applicants. The average 510(k) review took 97 days (median 52). FDA has posted 4 recalls for ELZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Crown, Preformed |
| Device class | Class I |
| Regulation | 21 CFR 872.3330 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ELZ clearance
Top ELZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| George M. Wilson, Dds | 3 | 1993-07-21 |
| Ez-Pedo, Inc. | 1 | 2009-06-29 |
| South American Dental Exporting Corp. | 1 | 1994-07-22 |
| Svenska Dental Instruments AB | 1 | 1989-06-06 |
| Whitecap Dental Co. | 1 | 1988-09-16 |
2 more applicants have ELZ clearances. See the full list in Caduvo.
Most recent ELZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091362 | Ez-Pedo, Inc. | CERAMIC PEDATRIC PREFORMED CROWN | 2009-06-29 | 52 |
| K932759 | South American Dental Exporting Corp. | TEMPOARY POLYCARBONATE CROWNS | 1994-07-22 | 409 |
| K931352 | George M. Wilson, Dds | PEDO JACKETS OR PJ'S | 1993-07-21 | 126 |
| K913152 | George M. Wilson, Dds | WHITER BITER CROWN | 1991-09-30 | 75 |
| K912686 | George M. Wilson, Dds | WHITER BITER CROWN | 1991-09-16 | 90 |
Recalls for ELZ devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-08-05.
Frequently asked questions
What is FDA product code ELZ?
ELZ is the FDA product code for crown, preformed. It is a Class I device, regulated under 21 CFR 872.3330 and reviewed by the Dental panel.
What device class is ELZ?
Class I, regulation 21 CFR 872.3330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ELZ?
Across 9 cleared submissions the average was 97 days from receipt to decision (median 52).
Which companies have the most ELZ clearances?
George M. Wilson, Dds (3); Ez-Pedo, Inc. (1); South American Dental Exporting Corp. (1); Svenska Dental Instruments AB (1); Whitecap Dental Co. (1).
Have ELZ devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2013-08-05.
Next steps
- Run an FDA pathway report with predicate devices for product code ELZ
- Run a recall and safety report across every ELZ manufacturer
- Watch product code ELZ 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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