The following data is part of a premarket notification filed by Astron Dental Corp. with the FDA for Modified Vinylac Press Pack Denture Resin.
| Device ID | K864757 |
| 510k Number | K864757 |
| Device Name: | MODIFIED VINYLAC PRESS PACK DENTURE RESIN |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | ASTRON DENTAL CORP. 280 HOLDBROOK DR. Wheeling, IL 60090 |
| Contact | Robert E Muller |
| Correspondent | Robert E Muller ASTRON DENTAL CORP. 280 HOLDBROOK DR. Wheeling, IL 60090 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-05 |
| Decision Date | 1987-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D810LCSE11 | K864757 | 000 |
| H66896347401 | K864757 | 000 |
| H66871105091 | K864757 | 000 |
| H66891431001 | K864757 | 000 |
| H66891431301 | K864757 | 000 |
| H66891431601 | K864757 | 000 |
| H66891431701 | K864757 | 000 |
| H66891432101 | K864757 | 000 |
| H66891432401 | K864757 | 000 |
| D810LCH818 | K864757 | 000 |
| D810LCHE11 | K864757 | 000 |
| D810LCS818 | K864757 | 000 |
| H66896346001 | K864757 | 000 |