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 |