Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EBG — Predicate Candidate Screening
189 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
254 days90th percentile
189clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-17 | 1 | 0 |
| K253380 | “FLNT Base” and “FLNT Temp” | Liaoning Upcera Co., Ltd. | 2026-03-02 | 153 | 0 |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | 2025-06-23 | 60 | 0 |
| K243370 | DentaTOOTH | Asiga Pty, Ltd. | 2025-05-05 | 187 | 0 |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | 2025-04-22 | 151 | 0 |
| K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | 2025-02-21 | 60 | 0 |
| K231859 | PrimmaArt | Dentscare Ltda | 2024-11-26 | 522 | 0 |
| K242559 | Digital Temp | Sprintray, Inc. | 2024-11-26 | 90 | 0 |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | 2024-07-19 | 144 | 0 |
| K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | 2024-05-31 | 29 | 0 |
| K233868 | dima Print Teeth & Temp | Kulzer, LLC | 2024-05-23 | 169 | 0 |
| K223706 | PMMA BLOCK | Huliang(Shanghai) Bio-Tech Co., Ltd. | 2023-05-12 | 151 | 0 |
| K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-02-16 | 90 | 0 |
| K202965 | CURA-Temp | Mgnewton , Ltd. | 2022-12-21 | 812 | 0 |
| K214071 | Hexa-Temp | Spident Co., Ltd. | 2022-03-10 | 73 | 0 |
| K213643 | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. | 2022-01-14 | 57 | 0 |
| K210817 | C&B 5.0 Hybrid | Arum Dentistry Co., Ltd. | 2021-12-08 | 265 | 0 |
| K211101 | E-Temp | Envisiontec GmbH | 2021-06-14 | 62 | 0 |
| K201563 | PuRE PMMA Disc | Quest Dental USA Corp. | 2021-04-09 | 303 | 0 |
| K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020-12-17 | 682 | 0 |
| K201827 | GR-17 Resin System | Pro3Dure Medical GmbH | 2020-11-05 | 126 | 0 |
| K201683 | PMMA Block | Huge Dental Material Co., Ltd. | 2020-11-03 | 134 | 0 |
| K200273 | FREEPRINT temp | Detax GmbH & Co. KG | 2020-10-27 | 266 | 0 |
| K201090 | Structur CAD | Voco GmbH | 2020-09-09 | 139 | 0 |
| K192830 | Bright Temporary C&B | Dmp Dental Industry S.A. | 2020-09-02 | 336 | 0 |
| K200039 | P pro Crown & Bridge | Deltamed GmbH | 2020-07-31 | 205 | 0 |
| K193113 | GC Temp Print | GC America, Inc. | 2020-07-09 | 240 | 0 |
| K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | Zirkonzahn Srl | 2020-07-08 | 114 | 0 |
| K193553 | VarseoSmile Temp | Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG | 2020-05-18 | 150 | 0 |
| K191590 | AA temp temporary restoration 3D printing photoreactive resi | Enlighten Materials Co., Ltd. | 2020-05-05 | 326 | 0 |
| K192022 | DiaTemp Flow | DiaDent Group International | 2020-02-13 | 199 | 0 |
| K192158 | DiaTemp | DiaDent Group International | 2020-02-13 | 188 | 0 |
| K192806 | DENTCA Crown and Bridge | Dentca, Inc. | 2020-02-05 | 127 | 0 |
| K192153 | Portux CAD/CAM Disc | New Stetic, SA | 2019-11-07 | 90 | 0 |
| K191843 | Ceramill A-Temp | Amann Girrbach AG | 2019-10-04 | 87 | 0 |
| K191619 | TurboTemp EZ | Zest Anchors, LLC | 2019-09-11 | 85 | 0 |
| K190930 | SmarTemp X1 | Parkell, Inc. | 2019-09-05 | 148 | 0 |
| K190724 | MD-Temp Plus | Meta Biomed Co., Ltd. | 2019-07-03 | 105 | 0 |
| K183337 | LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 | DMG Chemisch-Pharmazeutische Fabrik GmbH | 2019-05-29 | 177 | 0 |
| K182065 | EVOLUX CAD/CAM PMMA BLOCKS | Blue Dent Dental | 2018-12-13 | 134 | 0 |
| K180578 | Harvest Dental Polymer Blocks | Harvest Dental Products, LLC | 2018-12-12 | 282 | 0 |
| K180657 | Resin for Temporary Crown & Bridge | Dentis Co., Ltd. | 2018-12-07 | 269 | 0 |
| K180562 | TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATU | Zirkonzahn GmbH | 2018-06-28 | 115 | 0 |
| K171729 | Fixtemp C&B | Dreve Dentamid GmbH | 2017-12-13 | 184 | 0 |
| K172281 | PuRE PMMA Disc | Quest Dental USA Corp. | 2017-10-19 | 83 | 0 |
| K153490 | DD medical polymers | Dental Direkt GmbH | 2016-05-13 | 161 | 0 |
| K152443 | Vericore Gradient Temporary Disc | Whip Mix Corporation | 2016-05-11 | 258 | 0 |
| K153753 | TelioCAD Multi | Ivoclar Vivadent, Inc. | 2016-04-12 | 105 | 0 |
| K152215 | DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR | Dentalplus GmbH | 2016-01-19 | 165 | 0 |
| K151764 | YAMAHACHI PMMA DISKS | Yamahachi Dental Products USA, Inc. | 2015-11-23 | 146 | 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