The following data is part of a premarket notification filed by Whitecap Dental Co. with the FDA for Performed Crown (stainless Steel).
| Device ID | K883325 |
| 510k Number | K883325 |
| Device Name: | PERFORMED CROWN (STAINLESS STEEL) |
| Classification | Crown, Preformed |
| Applicant | WHITECAP DENTAL CO. BOX AB Swarthmore, PA 19081 |
| Contact | Lester E Burgess |
| Correspondent | Lester E Burgess WHITECAP DENTAL CO. BOX AB Swarthmore, PA 19081 |
| Product Code | ELZ |
| CFR Regulation Number | 872.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-05 |
| Decision Date | 1988-09-16 |