ELZ · Crown, Preformed
Dental · 21 CFR 872.3330 · Class 1
Overview
| Product Code | ELZ |
|---|---|
| Device Name | Crown, Preformed |
| Regulation | 21 CFR 872.3330 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A preformed crown is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be affixed temporarily to a tooth after removal of, or breakage of, the natural crown (that portion of the tooth that normally protrudes above the gums). It is intended for use as a functional restoration until a permanent crown is constructed. The device also may be intended for use as a functional restoration for a badly decayed deciduous (baby) tooth until the adult tooth erupts.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091362 | CERAMIC PEDATRIC PREFORMED CROWN | Ez-Pedo, Inc. | Jun 29, 2009 | SESE |
| K932759 | TEMPOARY POLYCARBONATE CROWNS | South American Dental Exporting Corp. | Jul 22, 1994 | SESE |
| K931352 | PEDO JACKETS OR PJ'S | George M. Wilson, Dds | Jul 21, 1993 | SESE |
| K913152 | WHITER BITER CROWN | George M. Wilson, Dds | Sep 30, 1991 | SESE |
| K912686 | WHITER BITER CROWN | George M. Wilson, Dds | Sep 16, 1991 | SESE |
| K892893 | SDI POLYCARBONATE CROWN, SCHEIN'S | Svenska Dental Instruments AB | Jun 6, 1989 | SESE |
| K883325 | PERFORMED CROWN (STAINLESS STEEL) | Whitecap Dental Co. | Sep 16, 1988 | SESE |
| K771128 | NEKO CERAMIC CONVENIENCE CROWNS | Sterndent Corp. | Jul 15, 1977 | SESE |
| K770684 | CROWN, ACRYLIC, CORAL BRAND, PREFORMED | Parker Laboratories, Inc. | Apr 26, 1977 | SESE |
Top Applicants
- George M. Wilson, Dds — 3 clearances
- Whitecap Dental Co. — 1 clearance
- Svenska Dental Instruments AB — 1 clearance
- Sterndent Corp. — 1 clearance
- South American Dental Exporting Corp. — 1 clearance
