510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151262Substantially Equivalent

Hyflex Heavy, Hyflex Mono, Hyflex Light

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

K151262 is the FDA 510(k) clearance record for Hyflex Heavy, Hyflex Mono, Hyflex Light, a class II device, cleared for Osstem Implant Co., Ltd. on under FDA product code ELW (Material, Impression). FDA records list 68 510(k) clearances for Osstem Implant Co., Ltd., from to . As of , FDA records show no recalls naming K151262.

Clearance record

Decision date
Received
(131 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
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 ELW

Trailing 12 months
3 clearances under product code ELW in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ELW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20262
October 20260