Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osstem Implant Co., Ltd. — Predicate Candidate Screening
68 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
156 daysmedian FDA review time
313 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251434 | Healing Abutment System | Osstem Implant Co., Ltd. | 2026-03-04 | 300 | 0 |
| K251569 | Bone Screw | Osstem Implant Co., Ltd. | 2025-08-13 | 83 | 0 |
| K242521 | Estar-ZE | Osstem Implant Co., Ltd. | 2024-11-20 | 89 | 0 |
| K233806 | T2 Plus | Osstem Implant Co., Ltd. | 2024-09-06 | 282 | 1 |
| K233194 | TS Abutment System | Osstem Implant Co., Ltd. | 2024-02-20 | 145 | 0 |
| K232220 | SS Abutment System | Osstem Implant Co., Ltd. | 2023-12-05 | 132 | 0 |
| K232012 | N1 | Osstem Implant Co., Ltd. | 2023-11-28 | 145 | 0 |
| K222778 | Osstem Implant System | Osstem Implant Co., Ltd. | 2023-09-23 | 374 | 0 |
| K221684 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2022-09-08 | 90 | 0 |
| K212303 | T2 | Osstem Implant Co., Ltd. | 2021-09-21 | 60 | 1 |
| K210097 | Estar-Z | Osstem Implant Co., Ltd. | 2021-07-02 | 169 | 0 |
| K210041 | HySil Plus Impression Materials | Osstem Implant Co., Ltd. | 2021-03-18 | 70 | 0 |
| K192941 | HySil Super Fast Impression Materials | Osstem Implant Co., Ltd. | 2020-01-30 | 104 | 0 |
| K183347 | K3 | Osstem Implant Co., Ltd. | 2019-09-04 | 275 | 0 |
| K183475 | T1-CS, T1-C | Osstem Implant Co., Ltd. | 2019-08-30 | 256 | 1 |
| K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2019-08-09 | 298 | 0 |
| K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019-07-12 | 343 | 0 |
| K181854 | OssBuilder System | Osstem Implant Co., Ltd. | 2019-05-07 | 300 | 0 |
| K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2018-09-13 | 126 | 0 |
| K172354 | OssBuilder System | Osstem Implant Co., Ltd. | 2018-03-26 | 235 | 0 |
| K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2017-06-07 | 89 | 0 |
| K161689 | OSSTEM Implant System - Abutment | Osstem Implant Co., Ltd. | 2017-05-22 | 336 | 2 |
| K163557 | SS SA Fixture | Osstem Implant Co., Ltd. | 2017-05-15 | 147 | 0 |
| K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017-04-25 | 411 | 0 |
| K163088 | TSIII BA Fixture | Osstem Implant Co., Ltd. | 2017-04-21 | 168 | 0 |
| K152830 | K3 | Osstem Implant Co., Ltd. | 2017-04-20 | 569 | 0 |
| K161103 | US SA Implant System | Osstem Implant Co., Ltd. | 2017-02-02 | 289 | 0 |
| K161197 | Orthodontic Screw | Osstem Implant Co., Ltd. | 2016-12-21 | 237 | 0 |
| K153015 | Transfer & Angled Abutment | Osstem Implant Co., Ltd. | 2016-12-05 | 417 | 0 |
| K160519 | Link Abutment for CEREC | Osstem Implant Co., Ltd. | 2016-10-28 | 246 | 0 |
| K161604 | OSSTEM Implant System | Osstem Implant Co., Ltd. | 2016-10-17 | 129 | 0 |
| K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. | 2015-09-21 | 131 | 0 |
| K141497 | PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) | Osstem Implant Co., Ltd. | 2014-08-26 | 81 | 0 |
| K140600 | SB ANCHOR | Osstem Implant Co., Ltd. | 2014-08-21 | 164 | 0 |
| K140507 | HIOSSEN PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | 2014-08-20 | 174 | 0 |
| K130662 | ET PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | 2014-01-10 | 304 | 4 |
| K130840 | SMARTBUILDER SYSTEM (SB1) | Osstem Implant Co., Ltd. | 2013-09-18 | 175 | 0 |
| K122124 | PORTABLE X-RAY SYSTEM | Osstem Implant Co., Ltd. | 2013-05-16 | 302 | 0 |
| K123755 | MULTI ANGLED ABUTMENT | Osstem Implant Co., Ltd. | 2013-04-26 | 140 | 0 |
| K121585 | TS IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2013-01-07 | 221 | 0 |
| K121843 | NP-CAST ABUTMENT SYSTEM | Osstem Implant Co., Ltd. | 2012-12-11 | 169 | 0 |
| K121995 | TS FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2012-11-29 | 143 | 0 |
| K122171 | MS SA IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2012-11-16 | 116 | 0 |
| K120951 | SMARTBUILDER SYSTEM | Osstem Implant Co., Ltd. | 2012-10-03 | 187 | 0 |
| K120847 | ET/SS IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2012-08-10 | 143 | 0 |
| K110308 | PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | 2011-10-03 | 243 | 0 |
| K103105 | ORTHODONTIC SCREW | Osstem Implant Co., Ltd. | 2011-03-25 | 156 | 0 |
| K100245 | HS/HG PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | 2010-08-17 | 202 | 0 |
| K091208 | GS III SYSTEM | Osstem Implant Co., Ltd. | 2010-03-03 | 313 | 0 |
| K091678 | HG II SHORT FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2010-02-18 | 253 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda