The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Tek-lube.
| Device ID | K925080 |
| 510k Number | K925080 |
| Device Name: | TEK-LUBE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | CLINICAL TECHNOLOGY CORP. 9735 NORTH 90TH PLACE, SUITE 100 Scottsdale, AZ 85258 |
| Contact | Ed Hayes |
| Correspondent | Ed Hayes CLINICAL TECHNOLOGY CORP. 9735 NORTH 90TH PLACE, SUITE 100 Scottsdale, AZ 85258 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-07 |
| Decision Date | 1994-01-31 |