510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053055Substantially Equivalent

Orthodontic Polymer Composite Bracket

Gestenco International AB, Goteborg, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K053055 is the FDA 510(k) clearance record for ORTHODONTIC POLYMER COMPOSITE BRACKET, a class II device, cleared for Gestenco International AB on under FDA product code DYW (Bracket, Plastic, Orthodontic). FDA records list one 510(k) clearance for Gestenco International AB. As of , FDA records show no recalls naming K053055.

Clearance record

Decision date
Received
(52 days to decision)
Product code
DYW Bracket, Plastic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Gestenco International AB 14 Fridkullagatan, Goteborg, SE
510(k) summary
Statement
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