The following data is part of a premarket notification filed by Tooth Aid Lab, Inc. with the FDA for Complete Denture Repair Kit.
| Device ID | K850927 |
| 510k Number | K850927 |
| Device Name: | COMPLETE DENTURE REPAIR KIT |
| Classification | Denture Repair Kit |
| Applicant | TOOTH AID LAB, INC. 4737 E. HOLLAND Fresno, CA 93726 |
| Contact | Norman Dean |
| Correspondent | Norman Dean TOOTH AID LAB, INC. 4737 E. HOLLAND Fresno, CA 93726 |
| Product Code | EBO |
| CFR Regulation Number | 872.3570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-05 |
| Decision Date | 1985-07-02 |