510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K081575Substantially Equivalent

Hu/hs/hg Prosthetic System

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

K081575 is the FDA 510(k) clearance record for HU/HS/HG PROSTHETIC SYSTEM, a class II device, cleared for Osstem Implant Co., Ltd. on under FDA product code NHA (Abutment, Implant, Dental, Endosseous). FDA's definition for product code NHA reads: "To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation". FDA records list 68 510(k) clearances for Osstem Implant Co., Ltd., from to . As of , FDA records show no recalls naming K081575.

Clearance record

Decision date
Received
(89 days to decision)
Product code
NHA Abutment, Implant, Dental, Endosseous
Regulation
21 CFR 872.3630
Device class
Class II
Review panel
Dental
Applicant
Osstem Implant Co., Ltd. 85 Ben Fairless Dr., Fariless Hills PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHA

Trailing 12 months
27 clearances under product code NHA in the twelve months to November 2026, June 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code NHA, trailing twelve months
MonthClearances
December 20254
January 20265
February 20261
March 20261
April 20262
May 20263
June 20266
July 20261
August 20261
September 20263
October 20260
November 20260