510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K940845Substantially Equivalent

System 1

Sybron Dental Specialties, Inc., Glendora CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940845 is the FDA 510(k) clearance record for SYSTEM 1, a class II device, cleared for Sybron Dental Specialties, Inc. on under FDA product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). FDA records list 176 510(k) clearances for Sybron Dental Specialties, Inc., from to . As of , FDA records show no recalls naming K940845.

Clearance record

Decision date
Received
(36 days to decision)
Product code
DYH Adhesive, Bracket And Tooth Conditioner, Resin
Regulation
21 CFR 872.3750
Device class
Class II
Review panel
Dental
Applicant
Sybron Dental Specialties, Inc. 1332 S. Lone Hill Ave., Glendora CA
510(k) summary
Summary
Third party review
No

Clearances, product code DYH

Trailing 12 months
3 clearances under product code DYH in the twelve months to November 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DYH, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20261
November 20260