Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Dental — Predicate Candidate Screening
12,644 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
157 daysmedian FDA review time
367 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | 2026-08-07 | 444 | 0 |
| K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | 2026-08-07 | 58 | 0 |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging | Nobel Biocare AB | 2026-08-06 | 234 | 0 |
| K261456 | Ruthinium Disc | Dental Manufacturing S.p.A. | 2026-08-05 | 96 | 0 |
| K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026-07-31 | 53 | 0 |
| K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | 2026-07-31 | 253 | 0 |
| K262681 | NanoCeram Resin | 3BFAB TEKNOLOJI A.S. | 2026-07-31 | 1 | 0 |
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026-07-30 | 29 | 0 |
| K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | 2026-07-25 | 302 | 0 |
| K261728 | One-Fil LC | Mediclus Co., Ltd. | 2026-07-21 | 56 | 0 |
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | 2026-07-17 | 108 | 0 |
| K261166 | DIA-CEM | DiaDent Group International | 2026-07-09 | 91 | 0 |
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026-07-08 | 1 | 0 |
| K253317 | Cytrans™ Elashield | GC America, Inc. | 2026-07-06 | 279 | 0 |
| K261847 | iTero Lumina™ Pro | Align Technology , Ltd. | 2026-07-02 | 29 | 0 |
| K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | 2026-07-02 | 135 | 0 |
| K261129 | OrthoFit | Spident Co., Ltd. | 2026-07-02 | 87 | 0 |
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | 2026-07-01 | 57 | 0 |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | 2026-07-01 | 58 | 0 |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | 2026-07-01 | 1 | 0 |
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-07-01 | 85 | 0 |
| K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | 2026-06-30 | 1 | 0 |
| K260918 | Zolid Lunaris | Amann Girrbach AG | 2026-06-29 | 102 | 0 |
| K261415 | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. | 2026-06-29 | 60 | 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 |
| K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | 2026-06-25 | 434 | 0 |
| K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 2026-06-18 | 266 | 0 |
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | 2026-06-18 | 422 | 0 |
| K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | 2026-06-18 | 204 | 0 |
| K261246 | SRGC-06 | GC America, Inc. | 2026-06-18 | 63 | 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 |
| K253723 | BOSS | Medpark Co., Ltd. | 2026-06-16 | 204 | 0 |
| K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-06-15 | 189 | 0 |
| K261366 | Virtus | Somnomed, Inc. | 2026-06-12 | 46 | 0 |
| K253052 | Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. | 2026-06-11 | 262 | 0 |
| K261251 | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | 2026-06-11 | 56 | 0 |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omn | Smart Denture Conversions, LLC | 2026-06-11 | 171 | 0 |
| K260859 | Rosetta SM, Rosetta SP | Hass Corp. | 2026-06-11 | 87 | 0 |
| K260564 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-06-09 | 110 | 0 |
| K261840 | BracePaste Prime Plus | American Orthodontics | 2026-06-03 | 1 | 0 |
| K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | 2026-06-03 | 2 | 0 |
| K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | 2026-06-03 | 265 | 0 |
| K261093 | DIAFIL | DiaDent Group International | 2026-06-02 | 61 | 0 |
| K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026-06-02 | 103 | 0 |
| K260367 | Portable Dental X-ray System Model PDX nova | PDX Co., Ltd. | 2026-05-27 | 112 | 0 |
| K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | 2026-05-21 | 237 | 0 |
| K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | 2026-05-20 | 175 | 0 |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill | DiaDent Group International | 2026-05-19 | 48 | 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