The following data is part of a premarket notification filed by Tycom Dental with the FDA for Quantec Series 2000 Endodontic Files.
| Device ID | K962031 |
| 510k Number | K962031 |
| Device Name: | QUANTEC SERIES 2000 ENDODONTIC FILES |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | TYCOM DENTAL 17802 FITCH AVE. Irvine, CA 92714 |
| Contact | Carol L Patterson |
| Correspondent | Carol L Patterson TYCOM DENTAL 17802 FITCH AVE. Irvine, CA 92714 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-24 |
| Decision Date | 1996-06-04 |
| Summary: | summary |