510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182672Substantially Equivalent

ROSA Bracket

Gni Co., Ltd., Hwaseong, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182672 is the FDA 510(k) clearance record for ROSA Bracket, a class II device, cleared for Gni Co., Ltd. on under FDA product code NJM (Bracket, Ceramic, Orthodontic). FDA's definition for product code NJM reads: "An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position". FDA records list 3 510(k) clearances for Gni Co., Ltd., from to . As of , FDA records show no recalls naming K182672.

Clearance record

Decision date
Received
(415 days to decision)
Product code
NJM Bracket, Ceramic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Gni Co., Ltd. 5f 501, 63-12 Dongtancheomdansaneop 1-Ro, Hwaseong, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NJM

Trailing 12 months

FDA records hold no clearances under product code NJM in the trailing twelve months.

FDA records show no clearances under product code NJM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NJM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260