510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170596Substantially Equivalent

TN-Brush

GENOSS Co., Ltd., Suwon-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K170596 is the FDA 510(k) clearance record for TN-Brush, a class II device, cleared for Genoss Co., Ltd. on under FDA product code ELB (Scaler, Rotary). FDA records list 23 510(k) clearances for Genoss Co., Ltd., from to . As of , FDA records show no recalls naming K170596.

Clearance record

Decision date
Received
(195 days to decision)
Product code
ELB Scaler, Rotary
Regulation
21 CFR 872.4840
Device class
Class II
Review panel
Dental
Applicant
Genoss Co., Ltd. 1f, Gyeonggi R&Db Center, 105 Gwanggyo-Ro,, Suwon-Si, KR
510(k) summary
Statement
Third party review
No

Clearances, product code ELB

Trailing 12 months

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

FDA records show no clearances under product code ELB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELB, 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