510(k) K130680
- Device
- ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
- Applicant
- DENTSOLL, INC.
- 510(k) number
- K130680
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-07-26
- Date received
- 2013-03-13
- 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
- DAVID C FURR
- Address
- 8708 Capehart Cove Austin TX US 78733 78733
FDA Registration Numbers#
- 3009496224
- 3008347275
- 4565
- 3012187973
- 1483306
- 3008320092
- 3015674635
- 3004905070
- 2424472
- 2515379
- 2023950
- 3040605150
- 1000486347
- 3039433962
- 8030452
- 3005665377
- 3001389926
- 3030686055
- 9680348
- 3024749697
- 2087259
- 3027494823
- 3013551048
- 3043226252
- 3027303702
- 1038806
- 3009312537
- 1410097
- 3015532223
- 3003310824
- 3017183443
- 3004966444
- 3020702076
- 1000625496
- 3033085428
- 2133714
- 3004935484
- 3044819802
- 3009440973
- 9681356
- 2954315
- 3008494285
- 2523320
- 3006542438
- 3004578725
- 3046274075
- 3004086252
- 2435952
- 3005459236
- 3011511773
- 1223843
- 9613953
- 3039359767
- 2081055
- 3004003391
- 3005904906
- 3013343038
- 3021381014
- 3003756493
- 9610902
- 1221541
- 9710611
- 3013425656
- 1000303432
- 3005350578
- 3007791519
- 3045857207
- 1316408
- 3003231822
- 2411797
- 2280629
- 3002807050
- 3027616
- 3016074824
- 2014676
- 3002789526
- 3014778017
- 3008757014
- 3012441963
- 3014289665
Source Documents#
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#
summary
FDA Review#
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