510(k) K210828
- Device
- DIOnavi-Denture02
- Applicant
- DIO Corporation
- 510(k) number
- K210828
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-23
- Date received
- 2021-03-19
- 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
- Yes
Applicant Contact#
- Contact
- Ji-Ae Park
- Address
- 66 Centumseo-Ro, Haeundae-Gu Busan KR 48058 48058
FDA Registration Numbers#
- 3009482106
- 1223843
- 3009432160
- 8044164
- 3011511773
- 3012421607
- 3027494823
- 3003621174
- 9681531
- 3022545323
- 9680954
- 3043226252
- 3004935484
- 1410097
- 2436918
- 2024312
- 2411797
- 3015491441
- 9612352
- 3026312357
- 1000277456
- 3008254125
- 3012623144
- 9616065
- 3005344553
- 3008347275
- 3044819802
- 3024227208
- 3027526455
- 3012389497
- 3011203516
- 3010664129
- 3006697692
- 3027303702
- 3017183443
- 1417322
- 3015674635
- 3004086252
- 3011532731
- 9680144
- 3010564008
- 3017374693
- 8030452
- 3009426332
- 3012441963
- 8010638
- 1417846
- 3013343038
- 3005665377
- 3006942327
- 3015532223
- 3004905070
- 3010279788
- 2515379
- 3008494285
- 3004003391
- 3009440973
- 1483306
- 8010711
- 3003756493
- 8031054
- 3016237718
- 2424472
- 2133714
- 3030686055
- 3003928050
- 2921595
- 3039433962
- 3014888923
- 9681356
- 3010368334
- 3006542438
- 3016074824
- 3020841418
- 2087259
- 9680348
- 3013934196
- 3040605150
- 8030870
Source Documents#
Other 510(k) Records For Product Code EBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250617 | Apex Flex | Sprintray, Inc. | 2025-04-29 |
Legacy Summary#
summary
FDA Review#
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