The following data is part of a premarket notification filed by Dental Power, Inc. with the FDA for Nt Swift; Ti\tec; Gates Glidden Drills; Dental Power Endodontic Hand Files.
| Device ID | K004031 |
| 510k Number | K004031 |
| Device Name: | NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES |
| Classification | File, Pulp Canal, Endodontic |
| Applicant | DENTAL POWER, INC. 24422 DEL PRADO # 11 Dana Point, CA 92629 |
| Contact | John Schoeffel |
| Correspondent | John Schoeffel DENTAL POWER, INC. 24422 DEL PRADO # 11 Dana Point, CA 92629 |
| Product Code | EKS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-28 |
| Decision Date | 2001-03-28 |