510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891372Substantially Equivalent

Orthodontic Plastic Bracket

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

K891372 is the FDA 510(k) clearance record for ORTHODONTIC PLASTIC BRACKET, a class II device, cleared for American Orthodontics on under FDA product code DYW (Bracket, Plastic, Orthodontic). FDA records list 46 510(k) clearances for American Orthodontics, from to . As of , FDA records show no recalls naming K891372.

Clearance record

Decision date
Received
(22 days to decision)
Product code
DYW Bracket, Plastic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
American Orthodontics 1714 Cambridge Ave., Sheboygan WI
Third party review
No

Clearances, product code DYW

Trailing 12 months
1 clearance under product code DYW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DYW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260