Product code ELZ
- Device name
- Crown, Preformed
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3330
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091362 | CERAMIC PEDATRIC PREFORMED CROWN | Ez-Pedo, Inc. | 2009-06-29 |
| K932759 | TEMPOARY POLYCARBONATE CROWNS | South American Dental Exporting Corp. | 1994-07-22 |
| K931352 | PEDO JACKETS OR PJ'S | George M. Wilson, Dds | 1993-07-21 |
| K913152 | WHITER BITER CROWN | George M. Wilson, Dds | 1991-09-30 |
| K912686 | WHITER BITER CROWN | George M. Wilson, Dds | 1991-09-16 |
| K892893 | SDI POLYCARBONATE CROWN, SCHEIN'S | Svenska Dental Instruments AB | 1989-06-06 |
| K883325 | PERFORMED CROWN (STAINLESS STEEL) | Whitecap Dental Co. | 1988-09-16 |
| K771128 | NEKO CERAMIC CONVENIENCE CROWNS | Sterndent Corp. | 1977-07-15 |
| K770684 | CROWN, ACRYLIC, CORAL BRAND, PREFORMED | Parker Laboratories, Inc. | 1977-04-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800012411144 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411373 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411366 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411359 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411342 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411335 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411328 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411311 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411304 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411298 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411281 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411274 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411175 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411168 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411151 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012410970 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411137 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411120 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411113 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411106 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411090 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411083 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411076 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411069 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411052 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411045 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411021 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012411014 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012410994 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |
| 08800012410987 | Hu-Friedy | HU-FRIEDY MFG. CO., LLC | 2024-10-14 |