510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893396Substantially Equivalent

An Alternative Direct Bonding Ortho. System

American Orthodontics, Sheboygan WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893396 is the FDA 510(k) clearance record for AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM, a class II device, cleared for American Orthodontics on under FDA product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). FDA records list 46 510(k) clearances for American Orthodontics, from to . As of , FDA records show no recalls naming K893396.

Clearance record

Decision date
Received
(53 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
American Orthodontics 1714 Cambridge Ave., Sheboygan WI
Third party review
No

Clearances, product code DYH

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