510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093221Substantially Equivalent

Pre-Cemented Orthodontic Bracket System Extension II

Dentsply Intl., York PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093221 is the FDA 510(k) clearance record for PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II, a class II device, cleared for Dentsply Intl., Inc. on under FDA product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). FDA records list 291 510(k) clearances for Dentsply Intl., Inc., from to . As of , FDA records show no recalls naming K093221.

Clearance record

Decision date
Received
(17 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
Dentsply Intl., Inc. Susquehanna Commerce Center, York PA
510(k) summary
Summary PDF
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