Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DZE — Predicate Candidate Screening
1,547 FDA 510(k) clearances under this product code; the 50 most recent screened below.
156 daysmedian FDA review time
399 days90th percentile
1,547clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | 2026-06-25 | 434 | 0 |
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | 2026-06-18 | 422 | 0 |
| K250806 | Dental Implant System | A.B. Dental Devices , Ltd. | 2026-06-18 | 458 | 0 |
| K260006 | INOSS System | Inosys, Inc. | 2026-06-17 | 166 | 0 |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano S | Promimic AB | 2026-05-12 | 257 | 0 |
| K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems , Ltd. | 2026-03-23 | 266 | 0 |
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026-03-16 | 167 | 0 |
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | 2026-03-10 | 243 | 0 |
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | 2026-03-04 | 128 | 0 |
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | 2026-02-18 | 219 | 0 |
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | 2026-02-02 | 194 | 0 |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026-01-08 | 146 | 0 |
| K252145 | GEN5™ and GEN5+™ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | 2025-12-23 | 167 | 0 |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025-12-23 | 307 | 0 |
| K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025-12-22 | 209 | 0 |
| K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-12-12 | 163 | 0 |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | 2025-11-07 | 210 | 0 |
| K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | 2025-10-30 | 128 | 0 |
| K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. | 2025-10-10 | 375 | 0 |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2025-09-29 | 280 | 0 |
| K251262 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-09-26 | 156 | 0 |
| K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl | 2025-09-25 | 164 | 0 |
| K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare AB | 2025-08-25 | 255 | 0 |
| K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Impl | Dentsply Sirona, Inc. | 2025-08-21 | 84 | 0 |
| K250271 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-08-18 | 200 | 0 |
| K251046 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-08-13 | 132 | 0 |
| K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | 2025-08-12 | 193 | 0 |
| K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2025-07-24 | 87 | 0 |
| K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025-07-23 | 173 | 0 |
| K251280 | DESS® Dental Implants | Terrats Medical SL | 2025-07-23 | 90 | 0 |
| K243731 | HEXIM Implant; Samwon General Abutments | P&A USA | 2025-07-09 | 217 | 0 |
| K243255 | URIS Long Implant & Abutments | Truabutment, Inc. | 2025-07-03 | 261 | 0 |
| K251660 | T3 Pro Implants– ZimVie Packaging System | Biomet 3i, LLC | 2025-06-27 | 28 | 0 |
| K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. | 2025-06-18 | 86 | 0 |
| K243002 | MBA Biotech Implant System | MBA Biotech Co., Ltd. | 2025-06-06 | 253 | 0 |
| K242072 | CeraRoot TL Implant System (TL) | Ceraroot SL | 2025-05-14 | 302 | 0 |
| K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | 2025-05-08 | 587 | 0 |
| K250176 | DAND Dental Implant System | D.A.N.D. Metal Industries North, Ltd. | 2025-04-21 | 89 | 0 |
| K241703 | SD Implant System | Arum Dentistry Co., Ltd. | 2025-02-24 | 256 | 0 |
| K241462 | LONGY Implant and LONGY-N Implant | Noris Medical , Ltd. | 2025-02-11 | 264 | 0 |
| K242217 | Surcam Dental Implant System | Surcam Medical Devices and Developments, Ltd. | 2025-01-29 | 184 | 0 |
| K242661 | TRI-matrix® X-Force Implants | Tri Dental Implants Int. AG | 2025-01-08 | 126 | 0 |
| K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025-01-06 | 116 | 0 |
| K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024-12-27 | 248 | 0 |
| K241972 | BLUEDIAMOND IMPLANT | Megagen Implant Co., Ltd. | 2024-12-27 | 175 | 0 |
| K240435 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH | 2024-12-20 | 310 | 0 |
| K243094 | Quickdent Dental Implant System | Quickdent Devices Private , Ltd. | 2024-12-19 | 80 | 0 |
| K243066 | Dental Implants and Abutments | Ditron Dental, Ltd. | 2024-12-16 | 80 | 0 |
| K241391 | Straumann® PURE Ceramic Implants | Institut Straumann AG | 2024-12-10 | 209 | 0 |
| K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2024-11-25 | 166 | 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