Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NHA — Predicate Candidate Screening
713 FDA 510(k) clearances under this product code; the 50 most recent screened below.
141 daysmedian FDA review time
304 days90th percentile
713clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging | Nobel Biocare AB | 2026-08-06 | 234 | 0 |
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-07-01 | 85 | 0 |
| K261122 | MIST IC | Imagine Milling Technologies, LLC | 2026-06-27 | 85 | 0 |
| K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026-06-26 | 169 | 0 |
| K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-06-15 | 189 | 0 |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omn | Smart Denture Conversions, LLC | 2026-06-11 | 171 | 0 |
| K260564 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-06-09 | 110 | 0 |
| K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | 2026-06-03 | 265 | 0 |
| K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | 2026-05-20 | 175 | 0 |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Hea | Hiossen, Inc. | 2026-05-14 | 226 | 0 |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutment | Institut Straumann AG | 2026-05-07 | 85 | 0 |
| K253804 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-04-16 | 139 | 0 |
| K260555 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2026-04-09 | 50 | 0 |
| K251434 | Healing Abutment System | Osstem Implant Co., Ltd. | 2026-03-04 | 300 | 0 |
| K251515 | Solidex® Ti-Links and Screws | CreoDent Hudson Valley | 2026-02-10 | 270 | 0 |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | 2026-01-29 | 266 | 0 |
| K243732 | Multi-Unit DAS System | Talladium España, SL | 2026-01-29 | 421 | 0 |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | 2026-01-22 | 115 | 0 |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | 2026-01-22 | 114 | 0 |
| K252727 | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-01-07 | 132 | 0 |
| K253341 | Custom Abutments AS | Medentika GmbH | 2025-12-23 | 84 | 0 |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 2025-12-23 | 84 | 0 |
| K252320 | SIMDA Abutments | Simda Co., Ltd. | 2025-12-18 | 146 | 0 |
| K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025-12-09 | 134 | 0 |
| K252248 | CEREC Tessera Abutment System | Dentsply Sirona | 2025-11-26 | 131 | 0 |
| K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neoden | Dentsply Sirona | 2025-11-21 | 217 | 0 |
| K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONEL | Prismatik Dentalcraft, Inc. | 2025-11-18 | 95 | 0 |
| K251547 | DESS Dental Smart Solutions | Terrats Medical SL | 2025-10-31 | 163 | 0 |
| K252384 | DESS® Dental Smart Solutions | Terrats Medical SL | 2025-10-23 | 84 | 0 |
| K252266 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-10-17 | 88 | 0 |
| K250178 | Adin Customized Abutments | Adin Dental Implant Systems , Ltd. | 2025-10-17 | 268 | 0 |
| K251497 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2025-10-16 | 154 | 0 |
| K251294 | Bonafix Implant Abutments | Zentek Medical, LLC | 2025-10-15 | 173 | 0 |
| K252944 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025-10-15 | 30 | 0 |
| K242287 | SFIT Abutment | Cowellmedi Co., Ltd. | 2025-09-16 | 410 | 0 |
| K242768 | Customized Abutment and Screw | Chengdu Besmile Medical Technology Co., Ltd. | 2025-09-02 | 354 | 0 |
| K251471 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2025-08-20 | 99 | 0 |
| K250721 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025-08-20 | 163 | 0 |
| K251220 | NUVENTUS NV.C™ Prosthetic Components | Infinitum Eta, Ltd. | 2025-07-28 | 98 | 0 |
| K241183 | ISO Abutment | Seum Medi Co., Ltd. | 2025-07-28 | 455 | 0 |
| K250967 | Sherlock | Open Implants, LLC | 2025-06-26 | 87 | 0 |
| K243009 | MIST IC | Imagine Milling Technologies, LLC | 2025-06-24 | 271 | 0 |
| K242978 | Geo Abutment | Geomedi Co,., Ltd. | 2025-06-16 | 263 | 0 |
| K243530 | Dynamic TiBase | Talladium España, SL | 2025-05-30 | 197 | 0 |
| K250614 | Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2025-05-27 | 88 | 0 |
| K250639 | DESS Dental Smart Solutions | Terrats Medical SL | 2025-05-22 | 80 | 0 |
| K243824 | Preat Abutments | Preat Corporation | 2025-05-08 | 147 | 0 |
| K243521 | Conical Ti Base abutments | BioHorizons Implant Systems, Inc. | 2025-05-01 | 169 | 0 |
| K250295 | Dentsply Sirona Titanium Bases system | Dentsply Sirona | 2025-04-30 | 89 | 0 |
| K242542 | Medentika CAD/CAM Abutments | Medentika GmbH | 2025-04-22 | 239 | 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