510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OSSTEM Implant Co., Ltd.

Haeundae-gu Busan, KR

OSSTEM IMPLANT CO., LTD. appears in FDA device records in Haeundae-gu Busan, KR. FDA records list 68 510(k) clearances between and , no PMA records and 5 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
68
PMA records
0
Recall records
3
Registered establishments
5

510(k) clearance history

Showing 50 of 68

FDA records hold 68 510(k) clearances for OSSTEM Implant Co., Ltd. between 2006 and 2026. The busiest year on record is 2008, with 11. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for OSSTEM Implant Co., Ltd., by decision year
YearClearances
20063
20072
200811
20092
20103
20112
20125
20134
20144
20151
20164
20177
20182
20195
20201
20213
20221
20233
20243
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251434Healing Abutment SystemNHASubstantially Equivalent
K251569Bone ScrewDZLSubstantially Equivalent
K242521Estar-ZEEIHSubstantially Equivalent
K233806T2 PlusOASSubstantially Equivalent
K233194TS Abutment SystemNHASubstantially Equivalent
K232220SS Abutment SystemNHASubstantially Equivalent
K232012N1EHDSubstantially Equivalent
K222778Osstem Implant SystemDZESubstantially Equivalent
K221684Osstem Abutment SystemNHASubstantially Equivalent
K212303T2OASSubstantially Equivalent
K210097Estar-ZEIHSubstantially Equivalent
K210041HySil Plus Impression MaterialsELWSubstantially Equivalent
K192941HySil Super Fast Impression MaterialsELWSubstantially Equivalent
K183347K3EIASubstantially Equivalent
K183475T1-CS, T1-COASSubstantially Equivalent
K182881Bone Screw, Bone TackDZLSubstantially Equivalent
K182091Osstem Abutment SystemNHASubstantially Equivalent
K181854OssBuilder SystemDZLSubstantially Equivalent
K181236HySil Impression MaterialsELWSubstantially Equivalent
K172354OssBuilder SystemJEYSubstantially Equivalent
K170736HySil Impression MaterialsELWSubstantially Equivalent
K161689OSSTEM Implant System - AbutmentNHASubstantially Equivalent
K163557SS SA FixtureDZESubstantially Equivalent
K160670ET US SS Prosthetic systemNHASubstantially Equivalent
K163088TSIII BA FixtureDZESubstantially Equivalent
K152830K3EIASubstantially Equivalent
K161103US SA Implant SystemDZESubstantially Equivalent
K161197Orthodontic ScrewOATSubstantially Equivalent
K153015Transfer & Angled AbutmentNHASubstantially Equivalent
K160519Link Abutment for CERECNHASubstantially Equivalent
K161604OSSTEM Implant SystemDZESubstantially Equivalent
K151262Hyflex Heavy, Hyflex Mono, Hyflex LightELWSubstantially Equivalent
K141497PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)EHDSubstantially Equivalent
K140600SB ANCHORNHASubstantially Equivalent
K140507HIOSSEN PROSTHETIC SYSTEMNHASubstantially Equivalent
K130662ET PROSTHETIC SYSTEMNHASubstantially Equivalent
K130840SMARTBUILDER SYSTEM (SB1)JEYSubstantially Equivalent
K122124PORTABLE X-RAY SYSTEMEHDSubstantially Equivalent
K123755MULTI ANGLED ABUTMENTNHASubstantially Equivalent
K121585TS IMPLANT SYSTEMDZESubstantially Equivalent
K121843NP-CAST ABUTMENT SYSTEMNHASubstantially Equivalent
K121995TS FIXTURE SYSTEMDZESubstantially Equivalent
K122171MS SA IMPLANT SYSTEMDZESubstantially Equivalent
K120951SMARTBUILDER SYSTEMJEYSubstantially Equivalent
K120847ET/SS IMPLANT SYSTEMDZESubstantially Equivalent
K110308PROSTHETIC SYSTEMNHASubstantially Equivalent
K103105ORTHODONTIC SCREWOATSubstantially Equivalent
K100245HS/HG PROSTHETIC SYSTEMNHASubstantially Equivalent
K091208GS III SYSTEMDZESubstantially Equivalent
K091678HG II SHORT FIXTURE SYSTEMDZESubstantially Equivalent

Registered establishments

FDA registered establishments for OSSTEM Implant Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30033940813003394081OSSTEM IMPLANT CO., LTD.66-16, Bansong-ro 513beon-gil,, Haeundae-gu Busan 48002 KR2026and 6 more, listed in full below
30149804693014980469OSSTEM IMPLANT CO., LTD.2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si Gyeonggi 15079 KR2026
30153327843015332784OSSTEM IMPLANT CO., LTD.A-DONG, 51, MAYU-RO 238BEON-GIL, SIHEUNG Gyeonggi 15079 KR2026
30318867963031886796OSSTEM IMPLANT CO., LTD.3, Magokjungang 12-ro, Gangseo-gu Seoul 07789 KR2026and 16 more, listed in full below
30458169483045816948OSSTEM IMPLANT CO.,LTD.104 Cheomdan-daero, Yeonsu-gu Incheon 21989 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0315-2026Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.Class IIOpen, Classified
Z-0314-2026Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.Class IIOpen, Classified
Z-0313-2026Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain