The following data is part of a premarket notification filed by Tycom Dental with the FDA for Nt Series Endodontic Files, Mac Series Endodontic Files.
| Device ID | K971319 |
| 510k Number | K971319 |
| Device Name: | NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | TYCOM DENTAL 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson TYCOM DENTAL 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-05-22 |
| Summary: | summary |