510(k) K953119
- Device
- BOSWORTH RESIN II
- Applicant
- BOSWORTH CO.
- 510(k) number
- K953119
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-08-28
- Date received
- 1995-07-03
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MILDRED M GOLDSTEIN
- Address
- 7227 N. Hamlin Ave. Skokie IL US 60076 60076
FDA Registration Numbers#
- 3004130302
- 1038806
- 3021381014
- 1000243214
- 3014778017
- 3005598536
- 3003310824
- 3004578725
- 3015674635
- 3008578884
- 3045857207
- 3010002722
- 4565
- 3030515618
- 2244842
- 3003103749
- 9612352
- 9680348
- 2242866
- 3043226252
- 2435952
- 1415367
- 1410097
- 3023346365
- 2086043
- 3005343849
- 2916735
- 1316408
- 3008494285
- 8030452
- 9681531
- 8010908
- 9616065
- 3011511773
- 9680954
- 2436918
- 3021024355
- 3022545323
- 1000118628
- 2515379
- 3013425656
- 2424472
- 3006694515
- 3013343038
- 3014289665
- 3027526455
- 3030686055
- 3009482106
- 3012389497
- 1000486347
- 1420052
- 3007126709
- 3004966444
- 8030870
- 2433919
- 3006542438
- 8021851
- 9613953
- 3012623144
- 3015532223
- 3017183443
- 3024749697
- 8010019
- 3008912871
- 8044164
- 3032727
- 3014270094
- 9612300
- 3005344553
- 3008910197
- 3008320092
- 3003756493
- 3001389926
- 1000303432
- 3039359767
- 3017374693
- 9610902
- 3016074824
- 3003928050
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#
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