510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081143Substantially Equivalent

Biomers Translucent Orthodontic Wire

Biomers Product, LLC, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081143 is the FDA 510(k) clearance record for BIOMERS TRANSLUCENT ORTHODONTIC WIRE, a class II device, cleared for Biomers Product, LLC on under FDA product code DYW (Bracket, Plastic, Orthodontic). FDA records list one 510(k) clearance for Biomers Product, LLC. As of , FDA records show no recalls naming K081143.

Clearance record

Decision date
Received
(10 days to decision)
Product code
DYW Bracket, Plastic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Biomers Product, LLC 2316 Pine Ridge Rd., Naples FL
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