510(k) K162044
- Device
- Dentca Denture Base II
- Applicant
- DENTCA, Inc.
- 510(k) number
- K162044
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-03-03
- Date received
- 2016-07-25
- Regulation
- 872.3760
- Classification name
- Resin, Denture, Relining, Repairing, Rebasing
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jason Lee
- Address
- 357 Van Ness Way #250 Torrance CA US 90501 90501
FDA Registration Numbers#
- 3005459236
- 3008757014
- 3012421607
- 3005665377
- 2183301
- 3011649314
- 9681356
- 1417846
- 3025124
- 3005344553
- 3011824442
- 3003310824
- 8030452
- 3008912871
- 1316408
- 3013934196
- 9610902
- 3027303702
- 2087259
- 3020841418
- 3005904906
- 9612300
- 3002789526
- 3015532223
- 8030870
- 3002807050
- 3009727738
- 3017374693
- 1223843
- 3004966444
- 3008910197
- 3010664129
- 3032727
- 3006542438
- 3030515618
- 2133714
- 1415367
- 3038718579
- 8010638
- 2023950
- 3009432160
- 9681199
- 3010368334
- 9616065
- 2921595
- 3011511773
- 3014270094
- 3024749697
- 8010711
- 3021381014
- 3020093493
- 9681210
- 3009496224
- 2244842
- 3014289665
- 3003621174
- 1000486347
- 3004003391
- 8031054
- 3040605150
- 3009440973
- 9680144
- 3010564008
- 3010002722
- 9680348
- 3003756493
- 3022545323
- 1000118628
- 2436918
- 2032112
- 3017450159
- 3008347275
- 3012389497
- 3027616
- 2081055
- 3007791519
- 8010908
- 3016237718
- 3013551048
- 3006694515
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026-06-02 |
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | 2026-05-06 |
| K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025-11-25 |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | Graphy, Inc. | 2025-11-21 |
| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | 2025-11-20 |
| K252430 | Freeprint® denture flex | Detax GmbH | 2025-10-30 |
| K252035 | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | Kamemizu Chemical Industry Co., Ltd. | 2025-09-17 |
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | 2025-06-25 |
| K242897 | Partial Flex | Clemde SA DE CV | 2025-06-03 |
| K250489 | FP3D | Keystone Industries | 2025-05-20 |
| K250617 | Apex Flex | Sprintray, Inc. | 2025-04-29 |
| K243356 | Asiga DentaBASE | Asiga Pty, Ltd. | 2025-04-11 |
| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-03-31 |
| K243103 | Denture Base | Riton 3D Technology Co., Ltd. | 2024-12-23 |
| K243336 | Lucitone Digital Print Denture™ System | Dentsply Sirona, Inc. | 2024-12-17 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases