ELZ
9 FDA 510(k) clearances · Product code
52 daysmedian time to decision
409 days90th percentile
9clearances measured
FDA profile
- Official device name
- Crown, Preformed
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3330
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1995: 1 · 2001: 1 · 2003: 2 · 2008: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CERAMIC PEDATRIC PREFORMED CROWN (K091362) | Ez-Pedo, Inc. | 2009-06-29 |
| TEMPOARY POLYCARBONATE CROWNS (K932759) | South American Dental Exporting Corp. | 1994-07-22 |
| PEDO JACKETS OR PJ'S (K931352) | George M. Wilson, Dds | 1993-07-21 |
| WHITER BITER CROWN (K913152) | George M. Wilson, Dds | 1991-09-30 |
| WHITER BITER CROWN (K912686) | George M. Wilson, Dds | 1991-09-16 |
| SDI POLYCARBONATE CROWN, SCHEIN'S (K892893) | Svenska Dental Instruments AB | 1989-06-06 |
| PERFORMED CROWN (STAINLESS STEEL) (K883325) | Whitecap Dental Co. | 1988-09-16 |
| NEKO CERAMIC CONVENIENCE CROWNS (K771128) | Sterndent Corp. | 1977-07-15 |
| CROWN, ACRYLIC, CORAL BRAND, PREFORMED (K770684) | Parker Laboratories, Inc. | 1977-04-26 |
Track ELZ automatically
Every clearance here is in the API, with alerts when new ones post.