The following data is part of a premarket notification filed by Professional Dental Studios with the FDA for Safe Tdent.
| Device ID | K820245 |
| 510k Number | K820245 |
| Device Name: | SAFE TDENT |
| Classification | Denture Repair Kit |
| Applicant | PROFESSIONAL DENTAL STUDIOS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBO |
| CFR Regulation Number | 872.3570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-29 |
| Decision Date | 1982-04-09 |