The following data is part of a premarket notification filed by Svenska Dental Instruments Ab with the FDA for S-file, S-finder, S-engine File.
| Device ID | K892894 |
| 510k Number | K892894 |
| Device Name: | S-FILE, S-FINDER, S-ENGINE FILE |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | SVENSKA DENTAL INSTRUMENTS AB P.O. BOX 1432 S-171 27 SOLNA Sweden, SE |
| Contact | Area Manager |
| Correspondent | Area Manager SVENSKA DENTAL INSTRUMENTS AB P.O. BOX 1432 S-171 27 SOLNA Sweden, SE |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-20 |
| Decision Date | 1989-05-24 |