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 |
|---|---|---|---|
| 08906154842539 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154843444 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154843376 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154843369 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154843352 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842638 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842621 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842614 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842607 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842591 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842584 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842577 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842560 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842553 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842546 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842522 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842515 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842508 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842492 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842485 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842478 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842461 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842454 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842447 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842430 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842423 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842416 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842409 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 08906154842393 | Bioflx Crown | KIDS-E-DENTAL LLP | 2026-05-30 |
| 07630031703408 | NA | Institut Straumann AG | 2023-07-27 |