The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Dental Root Elevator.
| Device ID | K892255 |
| 510k Number | K892255 |
| Device Name: | DENTAL ROOT ELEVATOR |
| Classification | Denture Preformed (partially Prefabricated Denture) |
| Applicant | ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Anthony Zinnanti |
| Correspondent | Anthony Zinnanti ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | EKO |
| CFR Regulation Number | 872.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-04 |
| Decision Date | 1989-05-01 |