510(k) K142890
- Device
- Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS E.max CAD MO Coping, IPS E.max CAD LT Crown, IPS E.max CAD HT Crown, Coron CoCr
- Applicant
- STRAUMANN USA, LLC
- 510(k) number
- K142890
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-09
- Date received
- 2014-10-03
- 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
- No
Applicant Contact#
- Contact
- Jennifer M. Jackson
- Address
- 60 Minuteman Rd. Andover MA US 01810 01810
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 |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | 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 |
Legacy Summary#
summary
FDA Review#
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