The following data is part of a premarket notification filed by Astron Dental Corp. with the FDA for Astron 77 Injection Denture Resin.
| Device ID | K833270 |
| 510k Number | K833270 |
| Device Name: | ASTRON 77 INJECTION DENTURE RESIN |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | ASTRON DENTAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-21 |
| Decision Date | 1984-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8101180MFT11 | K833270 | 000 |
| D8101180LFT11 | K833270 | 000 |
| D8101180EC11 | K833270 | 000 |