510(k) K151798
- Device
- Inclusive Titanium Abutments Compatible With: Straumann SynOcta Implant System
- Applicant
- PRISMATIK DENTALCRAFT, INC.
- 510(k) number
- K151798
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-16
- Date received
- 2015-07-02
- 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
- ARMIN ZEHTABCHI
- Address
- 2212 Dupont Dr., Suite P Irvine CA US 92612 92612
FDA Registration Numbers#
- 3030039110
- 3005121682
- 3031529635
- 3006110126
- 3007362683
- 3008791019
- 3004884150
- 3040978916
- 3015775866
- 8010591
- 3014129047
- 3013111980
- 2027062
- 3014142650
- 3002807050
- 3009742323
- 3009514134
- 3007521935
- 3012422693
- 3012187973
- 3011390931
- 3009482100
- 3035532394
- 2530808
- 3038136479
- 2183828
- 3015383403
- 3014329459
- 3006948193
- 3010948854
- 3010876315
- 3008517893
- 3045005836
- 3008496301
- 3008088588
- 1054986
- 3010251542
- 2024024
- 3009432160
- 3014174860
- 2433919
- 3036779616
- 3010160527
- 3009840806
- 1222315
- 3017125693
- 3009217531
- 3005126636
- 3015194291
- 3007515069
- 1410097
- 8044131
- 3002808227
- 3009848796
- 3012635238
- 3006017180
- 3010287685
- 3008347275
- 3003310824
- 3017399129
- 3008409772
- 8043971
- 3009732568
- 3025338240
- 3029906226
- 3014112268
- 3009795022
- 3010363503
- 3024185724
- 3012421607
- 3015218457
- 3013527433
- 8031058
- 3013465593
- 3005952241
- 3013167159
- 9613953
- 3030690317
- 3009551666
- 1220477
Source Documents#
Other 510(k) Records For Product Code NHA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-07-01 |
| K261122 | MIST IC | Imagine Milling Technologies, LLC | 2026-06-27 |
| K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026-06-26 |
| K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-06-15 |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026-06-11 |
| K260564 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-06-09 |
| 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 |
| K243732 | Multi-Unit DAS System | Talladium España, SL | 2026-01-29 |
Legacy Summary#
summary
FDA Review#
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