510(k) K122348
- Device
- QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW
- Applicant
- RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)
- 510(k) number
- K122348
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-10-15
- Date received
- 2012-08-03
- 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
- MANH-QUYNH CHU
- Address
- 3 Rue Louis Neel St. Egreve FR 38120 38120
FDA Registration Numbers#
- 3024227208
- 4565
- 2954315
- 3012441963
- 1416675
- 3038718579
- 3008494285
- 1415367
- 3014778017
- 3006542438
- 2523320
- 2244842
- 8030870
- 3005350578
- 1000625496
- 3017183443
- 9681199
- 8010711
- 3013343038
- 3004578725
- 1221541
- 2081055
- 8031054
- 8010638
- 3010564008
- 2023950
- 3014888923
- 1000118628
- 3007126709
- 2411797
- 1223843
- 3005598536
- 3014289665
- 3039433962
- 3008320092
- 8010908
- 3002789526
- 3005343849
- 1410097
- 3003231822
- 2032807
- 2435952
- 3002807050
- 2921595
- 3011649314
- 3021381014
- 3004130302
- 3004003391
- 3011532731
- 3020093493
- 3009727738
- 3013425656
- 3017374693
- 8044164
- 3011824442
- 3027616
- 9612300
- 3008912871
- 3021024355
- 3040605150
- 3008590411
- 3022068322
- 3012623144
- 3039359767
- 3012421607
- 3003621174
- 3033085428
- 3006694515
- 2424472
- 3010664129
- 3013934196
- 3005665377
- 2086043
- 9680954
- 3009312537
- 8030452
- 3010002722
- 3015532223
- 3027494823
- 3030515618
Source Documents#
Other 510(k) Records For Product Code EBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-11-22 |
Legacy Summary#
summary
FDA Review#
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