510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K061252Substantially Equivalent

Pre-Cemented Orthodontic Bracket System

Primus Consulting, Bradenton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061252 is the FDA 510(k) clearance record for PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM, a class II device, cleared for Primus Consulting on under FDA product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). FDA records list one 510(k) clearance for Primus Consulting. As of , FDA records show no recalls naming K061252.

Clearance record

Decision date
Received
(284 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
Primus Consulting 7046 Owl'S Nest Ter., Bradenton FL
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