510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251196Substantially Equivalent

Composite Orthodontic Brackets and Buttons

EC Certification Service GmbH, Sankt Veit An Der Glan, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251196 is the FDA 510(k) clearance record for Composite Orthodontic Brackets and Buttons, a class II device, cleared for Ec Certification Service GmbH on under FDA product code DYW (Bracket, Plastic, Orthodontic). FDA records list one 510(k) clearance for Ec Certification Service GmbH. As of , FDA records show no recalls naming K251196.

Clearance record

Decision date
Received
(4 days to decision)
Product code
DYW Bracket, Plastic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Ec Certification Service GmbH Sandgasse 39a, Sankt Veit An Der Glan, AT
510(k) summary
Summary PDF
Third party review
Yes

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