510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161604Substantially Equivalent

OSSTEM Implant System

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

K161604 is the FDA 510(k) clearance record for OSSTEM Implant System, a class II device, cleared for Osstem Implant Co., Ltd. on under FDA product code DZE (Implant, Endosseous, Root-Form). FDA records list 68 510(k) clearances for Osstem Implant Co., Ltd., from to . As of , FDA records show no recalls naming K161604.

Clearance record

Decision date
Received
(129 days to decision)
Product code
DZE Implant, Endosseous, Root-Form
Regulation
21 CFR 872.3640
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 DZE

Trailing 12 months
19 clearances under product code DZE in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code DZE, trailing twelve months
MonthClearances
November 20251
December 20254
January 20261
February 20262
March 20264
April 20260
May 20261
June 20264
July 20260
August 20261
September 20261
October 20260