510(k) K253315
- Device
- Straumann Variobase Abutments XC for Bridge/Bar
- Applicant
- Institut Straumann AG
- 510(k) number
- K253315
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-22
- Date received
- 2025-09-30
- Regulation
- 872.3630
- Classification name
- Abutment, Implant, Dental, Endosseous
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Olivier Russo
- Address
- Peter Merian-Weg 12 P.O. Box Basel CH 4002 4002
FDA Registration Numbers#
- 3031462380
- 3003394627
- 1054986
- 3011824442
- 3031553803
- 1526534
- 1000244346
- 3013102320
- 2087259
- 9612300
- 3013271380
- 3005663340
- 3009727738
- 1223843
- 3004883837
- 3015527825
- 2029005
- 3005512166
- 3004748290
- 3007597023
- 3030690317
- 3038715999
- 9681199
- 3010160527
- 3007218081
- 3009611645
- 3014270094
- 3005952241
- 3014142650
- 2244842
- 3008693672
- 3012205930
- 3008793310
- 3007362683
- 3011936113
- 3011656326
- 2530808
- 3011808221
- 3014540272
- 3012354669
- 3008347275
- 3000279043
- 3003781339
- 3039397999
- 3015160953
- 3013551048
- 3006948193
- 9613348
- 3039641923
- 3014107733
- 3008409772
- 3007649394
- 3011390931
- 3014843857
- 3022316560
- 3005503242
- 9611993
- 3016172557
- 3023852420
- 1627417
- 3017980266
- 3007126709
- 3009632672
- 3003184527
- 8010591
- 1000625496
- 3015978392
- 3009756327
- 3015383403
- 3012106319
- 3021076825
- 9611992
- 3001110146
- 3009779268
- 3007689689
- 3010162973
- 3009551666
- 3016447764
- 3032439351
- 9613662
Source Documents#
Other 510(k) Records For Product Code NHA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | 2026-06-03 |
| K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | 2026-05-20 |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | 2026-05-14 |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | 2026-05-07 |
| K253804 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-04-16 |
| K260555 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2026-04-09 |
| K251434 | Healing Abutment System | Osstem Implant Co., Ltd. | 2026-03-04 |
| K251515 | Solidex® Ti-Links and Screws | CreoDent Hudson Valley | 2026-02-10 |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | 2026-01-29 |
| K243732 | Multi-Unit DAS System | Talladium España, SL | 2026-01-29 |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | 2026-01-22 |
| K252727 | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-01-07 |
| K253341 | Custom Abutments AS | Medentika GmbH | 2025-12-23 |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 2025-12-23 |
| K252320 | SIMDA Abutments | Simda Co., Ltd. | 2025-12-18 |