The following data is part of a premarket notification filed by Dentmed Ltd. with the FDA for Dentolock.
| Device ID | K921071 |
| 510k Number | K921071 |
| Device Name: | DENTOLOCK |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | DENTMED LTD. 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer DENTMED LTD. 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-06 |
| Decision Date | 1992-03-26 |