510(k) K233995
- Device
- Ivotion Base Print
- Applicant
- Ivoclar Vivadent, Inc.
- 510(k) number
- K233995
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-23
- Date received
- 2023-12-18
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Anderjeet Gulati
- Address
- 175 Pineview Dr. Amherst NY US 14228 14228
FDA Registration Numbers#
- 1221541
- 3009496224
- 3010564008
- 3005904906
- 3014289665
- 3004966444
- 3012623144
- 3027494823
- 3025124
- 3012441963
- 3007791519
- 3013934196
- 3009727738
- 3040605150
- 2242866
- 3003310824
- 8021851
- 3023346365
- 9681356
- 3003928050
- 1416675
- 1417322
- 3016074824
- 3027616
- 1043617
- 3012187973
- 1223843
- 8010019
- 2032112
- 3008757014
- 2086043
- 3015674635
- 3008254125
- 1000243214
- 3005459236
- 3038718579
- 8044164
- 9610902
- 3022068322
- 3032727
- 9681199
- 2515379
- 3003231822
- 3009482106
- 3009426332
- 8010711
- 3008569063
- 2523320
- 3003103749
- 8031054
- 3011203516
- 9613953
- 3006694515
- 9681210
- 3001389926
- 9680144
- 2280629
- 3017374693
- 2424472
- 2950685
- 3008320092
- 1483306
- 3010002722
- 9612352
- 3014270094
- 1316408
- 3005344553
- 3012389497
- 3011824442
- 3010664129
- 3008347275
- 9681531
- 3011649314
- 9710611
- 3013551048
- 1000303432
- 3030686055
- 3004935484
- 3008912871
- 3014888923
Source Documents#
Other 510(k) Records For Product Code EBI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |