CERAMIC PEDATRIC PREFORMED CROWN
FDA 510(k) clearance K091362 · decided 2009-06-29
Clearance details
- K-number
- K091362
- Device name
- CERAMIC PEDATRIC PREFORMED CROWN
- Applicant
- Ez-Pedo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-08
- Decision date
- 2009-06-29
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- ELZ
- Device class
- 1
- Regulation number
- 872.3330
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Roseville, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.