510(k) K090723
- Device
- HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,
- Applicant
- ZIMMER DENTAL INC.
- 510(k) number
- K090723
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-04-07
- Date received
- 2009-03-09
- Regulation
- 872.3630
- Classification name
- Abutment, Implant, Dental, Endosseous
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM FISHER
- Address
- 1900 Aston Ave. Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 3030690317
- 3005512166
- 3014540272
- 3013173272
- 3014142650
- 2023950
- 3005562917
- 3024852742
- 3010303805
- 3023878501
- 9611992
- 3009737865
- 3004370612
- 3010860907
- 3013547803
- 3021076825
- 3005998060
- 3017125693
- 3004443656
- 3011649314
- 3020144887
- 3004884150
- 9613866
- 3007536957
- 3011824442
- 3013111980
- 3008886124
- 3009847764
- 3005554774
- 3011187779
- 3009514134
- 3003184527
- 3015383403
- 3009761487
- 3016733895
- 3013111692
- 3027595870
- 3027494823
- 3011461101
- 3031162123
- 3008261720
- 8031058
- 3003310824
- 3009646999
- 1222802
- 3015194291
- 3005106408
- 3011545243
- 3004860162
- 9612352
- 3013264549
- 3012690648
- 3013551048
- 3001082453
- 3008812251
- 3010730876
- 3018662547
- 3023265483
- 2530808
- 3022316560
- 3014107733
- 3031886796
- 8010516
- 3004556094
- 3030089802
- 3006540014
- 3025338240
- 9613953
- 3012187973
- 3011575197
- 3038549074
- 9611993
- 3003847101
- 3010407203
- 3009551666
- 3009482100
- 3004417597
- 3005121682
- 3030255892
Source Documents#
Other 510(k) Records For Product Code NHA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | 2026-01-22 |
| 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 |
Legacy Summary#
summary
FDA Review#
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