The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travenol Disposable Dental Scalers/curettes.
| Device ID | K854168 |
| 510k Number | K854168 |
| Device Name: | TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES |
| Classification | Instrument, Hand, Calculus Removal |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Brian Stembal |
| Correspondent | Brian Stembal TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | ELA |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-15 |
| Decision Date | 1986-03-13 |