510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152125Substantially Equivalent

Oral Surgery System and Accessories

Bonart Co. Ltd., Xinzhuang Dist., TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K152125 is the FDA 510(k) clearance record for Oral Surgery System and Accessories, a class II device, cleared for Bonart Co., Ltd. on under FDA product code DZI (Drill, Bone, Powered). FDA records list 14 510(k) clearances for Bonart Co., Ltd., from to . As of , FDA records show no recalls naming K152125.

Clearance record

Decision date
Received
(381 days to decision)
Product code
DZI Drill, Bone, Powered
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Bonart Co., Ltd. 4f-1, # 3 Wuquan 1st Rd., Xinzhuang Dist., TW
510(k) summary
Statement
Third party review
No

Clearances, product code DZI

Trailing 12 months
3 clearances under product code DZI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260