The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Apex Finder Models 7005.
Device ID | K962803 |
510k Number | K962803 |
Device Name: | APEX FINDER MODELS 7005 |
Classification | Locator, Root Apex |
Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
Contact | Willian R Pike |
Correspondent | Willian R Pike SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
Product Code | LQY |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-18 |
Decision Date | 1996-10-08 |
Summary: | summary |