510(k) K143486
- Device
- Ufi Gel Hard C
- Applicant
- VOCO GMBH
- 510(k) number
- K143486
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-07
- Date received
- 2014-12-08
- Regulation
- 872.3760
- Classification name
- Resin, Denture, Relining, Repairing, Rebasing
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- M.Th. Plaumann
- Address
- Anton-Flettner-Str 1-3 Cuxhaven DE D-27472 D-27472
FDA Registration Numbers#
- 3005665377
- 3030515618
- 2950685
- 3005350578
- 3003231822
- 8030452
- 1410097
- 3023346365
- 3026312357
- 3011824442
- 8010019
- 1483306
- 3027616
- 9680348
- 3017374693
- 8010711
- 2280629
- 3008912871
- 1221541
- 1038806
- 3010664129
- 2032807
- 2433919
- 2436918
- 3011511773
- 3014888923
- 3003928050
- 3043226252
- 3006694515
- 3022068322
- 3009482106
- 3004003391
- 2411797
- 1417322
- 3008569063
- 3012623144
- 1000243214
- 3004905070
- 2081055
- 2244842
- 3005459236
- 3011532731
- 3030686055
- 2530024
- 2133714
- 3017183443
- 3020841418
- 3004966444
- 9612352
- 3012187973
- 3007233968
- 9681356
- 3002789526
- 2424472
- 3012421607
- 2023950
- 3003103749
- 3027303702
- 3012441963
- 3014289665
- 1000277456
- 3024749697
- 2087259
- 3009440973
- 9680144
- 3027526455
- 3007126709
- 2515379
- 3010002722
- 9616065
- 3005344553
- 2024312
- 3009727738
- 3008347275
- 9612300
- 3009312537
- 2916735
- 3008757014
- 3006942327
- 4565
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261802 | Glidewell™ Denture Base Resin | Prismatik Dentalcraft, Inc. | 2026-08-27 |
| K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | 2026-08-13 |
| K262681 | NanoCeram Resin | 3BFAB TEKNOLOJI A.S. | 2026-07-31 |
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026-07-08 |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | 2026-07-01 |
| 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 |
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