Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EBI · Predicate Candidate Screening
333 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
203 days90th percentile
333clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262681 | NanoCeram Resin | 3BFAB TEKNOLOJI A.S. | 2026-07-31 | 1 | 0 |
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026-07-08 | 1 | 0 |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | 2026-07-01 | 58 | 0 |
| K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026-06-02 | 103 | 0 |
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | 2026-05-06 | 90 | 0 |
| K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025-11-25 | 56 | 0 |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture ( | Graphy, Inc. | 2025-11-21 | 0 | 0 |
| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | 2025-11-20 | 51 | 0 |
| K252430 | Freeprint® denture flex | Detax GmbH | 2025-10-30 | 90 | 0 |
| K252035 | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DEN | Kamemizu Chemical Industry Co., Ltd. | 2025-09-17 | 79 | 0 |
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | 2025-06-25 | 142 | 0 |
| K242897 | Partial Flex | Clemde SA DE CV | 2025-06-03 | 253 | 0 |
| K250489 | FP3D | Keystone Industries | 2025-05-20 | 90 | 0 |
| K250617 | Apex Flex | Sprintray, Inc. | 2025-04-29 | 60 | 0 |
| K243356 | Asiga DentaBASE | Asiga Pty, Ltd. | 2025-04-11 | 164 | 0 |
| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-03-31 | 3 | 0 |
| K243103 | Denture Base | Riton 3D Technology Co., Ltd. | 2024-12-23 | 84 | 0 |
| K243336 | Lucitone Digital Print Denture™ System | Dentsply Sirona, Inc. | 2024-12-17 | 54 | 0 |
| K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-11-22 | 60 | 0 |
| K241089 | KeyPrint KeyDenture Base | Keystone Industries | 2024-10-24 | 188 | 0 |
| K241493 | Glidewell™ 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2024-09-12 | 107 | 0 |
| K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | 2024-09-04 | 138 | 0 |
| K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | 2024-06-20 | 99 | 0 |
| K233859 | BASIS FLOW II | YAMAHACHI DENTAL MFG., Co. | 2024-03-05 | 90 | 0 |
| K233995 | Ivotion Base Print | Ivoclar Vivadent, Inc. | 2024-02-23 | 67 | 0 |
| K233171 | PF Keep; Cad Cam Keep Block | Clemde SA DE CV | 2023-11-27 | 60 | 0 |
| K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023-10-20 | 142 | 0 |
| K231388 | NextDent Base | Vertex-Dental B.V. | 2023-10-20 | 161 | 0 |
| K232691 | Polibond | Zirkonzahn Srl | 2023-09-05 | 4 | 0 |
| K231389 | Harvest Dental HD Gum Strip | Harvest Dental Products, LLC | 2023-08-16 | 96 | 0 |
| K230445 | OnX Tough | Sprintray, Inc. | 2023-07-14 | 143 | 0 |
| K230410 | DD medical polymers (PMMA) | Dental Direkt GmbH | 2023-06-23 | 128 | 0 |
| K222489 | Harvest Printable Resin | Harvest Dental Products, LLC | 2023-05-12 | 268 | 0 |
| K230098 | Trusana™ | Myerson, LLC | 2023-04-13 | 90 | 0 |
| K230341 | ACRIFIX | Deltamed GmbH | 2023-04-06 | 57 | 0 |
| K230115 | Denture Base Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-03-17 | 59 | 0 |
| K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Dentca, Inc. | 2022-11-17 | 316 | 0 |
| K221678 | SprintRay High Impact Denture Base | Sprintray, Inc. | 2022-11-10 | 154 | 0 |
| K220236 | V-Print dentbase | Voco GmbH | 2022-09-21 | 237 | 0 |
| K220979 | SprintRay Denture Base | Sprintray, Inc. | 2022-09-14 | 163 | 0 |
| K220680 | Denture Base Polymers | Shandong Huge Dental Material Corporation | 2022-08-12 | 157 | 0 |
| K222414 | TERA HARZ DENTURE | Graphy, Inc. | 2022-08-11 | 1 | 0 |
| K220771 | Stratasys TrueDent | Stratasys, Ltd. | 2022-07-07 | 113 | 5 |
| K220743 | CediTEC | Voco GmbH | 2022-07-05 | 113 | 0 |
| K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2022-06-22 | 203 | 0 |
| K213994 | Flexible Block | Shandong Huge Dental Material Corporation | 2022-03-04 | 73 | 0 |
| K212541 | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture F | Deltamed GmbH | 2022-01-10 | 151 | 0 |
| K210189 | Pac-Dent Denture Base Resin | Pac-Dent, Inc. | 2021-07-28 | 184 | 0 |
| K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | 2021-05-05 | 91 | 0 |
| K203641 | E-Denture Pro | Envisiontec GmbH | 2021-03-30 | 106 | 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