The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Tf Rotary Nickel Titanium File.
| Device ID | K062856 |
| 510k Number | K062856 |
| Device Name: | TF ROTARY NICKEL TITANIUM FILE |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | ORMCO CORP. 100 BAYVIEW CIRCLE SUITE 6000 Newport Beach, CA 92660 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell ORMCO CORP. 100 BAYVIEW CIRCLE SUITE 6000 Newport Beach, CA 92660 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-25 |
| Decision Date | 2006-12-13 |
| Summary: | summary |