Crown, Preformed
The Preformed Crown is a prefabricated stainless steel, polycarbonate, or other material crown designed to be trimmed and adapted chairside to fit over a prepared tooth or primary tooth, providing temporary or permanent protection, particularly for pediatric patients following pulp therapy or significant tooth structure loss. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is ELZ, regulated under 21 CFR 872.3330 in the Dental (DE) specialty.
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Basic Information
- Product Code
- ELZ
- Device Class
- FDA class 1
- Regulation Number
- 872.3330
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091362 | CERAMIC PEDATRIC PREFORMED CROWN | Jun 29, 2009 | Substantially Equivalent | Ez-Pedo, Inc. |
| K932759 | TEMPOARY POLYCARBONATE CROWNS | Jul 22, 1994 | Substantially Equivalent | South American Dental Exporting Corp. |
| K931352 | PEDO JACKETS OR PJ'S | Jul 21, 1993 | Substantially Equivalent | George M. Wilson, Dds |
| K913152 | WHITER BITER CROWN | Sep 30, 1991 | Substantially Equivalent | George M. Wilson, Dds |
| K912686 | WHITER BITER CROWN | Sep 16, 1991 | Substantially Equivalent | George M. Wilson, Dds |
| K892893 | SDI POLYCARBONATE CROWN, SCHEIN'S | Jun 06, 1989 | Substantially Equivalent | Svenska Dental Instruments AB |
| K883325 | PERFORMED CROWN (STAINLESS STEEL) | Sep 16, 1988 | Substantially Equivalent | Whitecap Dental Co. |
| K771128 | NEKO CERAMIC CONVENIENCE CROWNS | Jul 15, 1977 | Substantially Equivalent | Sterndent Corp. |
| K770684 | CROWN, ACRYLIC, CORAL BRAND, PREFORMED | Apr 26, 1977 | Substantially Equivalent | Parker Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 127 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 127 registration numbers. Click on an entry to view related FDA registrations.