510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181854Substantially Equivalent

OssBuilder System

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

K181854 is the FDA 510(k) clearance record for OssBuilder System, a class II device, cleared for Osstem Implant Co., Ltd. on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 68 510(k) clearances for Osstem Implant Co., Ltd., from to . As of , FDA records show no recalls naming K181854.

Clearance record

Decision date
Received
(300 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Osstem Implant Co., Ltd. 66-16, Bansong-Ro 513beon-Gil, Haeundae-Gu, Busan, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZL

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