510(k) K202144
- Device
- A.B. Dental Devices Dental Implants System
- Applicant
- A.B. Dental Device Ltd.
- 510(k) number
- K202144
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-09-23
- Date received
- 2020-07-31
- 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
- Gabi Krauss
- Address
- 19 Hayalomim St. Ashdod IL 7761117 7761117
FDA Registration Numbers#
- 3009528826
- 3003781339
- 1424263
- 3007597023
- 3001082453
- 3011649314
- 9614404
- 1000577893
- 3017833095
- 3004370612
- 3001617766
- 3023265483
- 3007366413
- 3026365523
- 3013934196
- 3043585140
- 3013960456
- 3010178296
- 3002808227
- 3008791019
- 3013102320
- 3005663340
- 3008102042
- 1222802
- 3013343038
- 3007031098
- 3031886796
- 9617542
- 3012187973
- 3007728094
- 3006796211
- 3011187779
- 3009848796
- 3013376795
- 3010407203
- 3034686762
- 3007536957
- 3009217531
- 3018097239
- 9681199
- 8020776
- 3004748290
- 2246552
- 3039641923
- 3038715999
- 3015620565
- 3009732568
- 3004860162
- 1036836
- 3005121682
- 3005383085
- 3016954909
- 3003394081
- 3008261720
- 3011221537
- 3013562441
- 3012690648
- 3022316560
- 3017980266
- 3029906226
- 3030039110
- 3033708818
- 2027971
- 9613953
- 8043792
- 3012465917
- 1226544
- 3011587077
- 2249649
- 3005941719
- 3031529635
- 9612352
- 3013547803
- 3005497913
- 3013271380
- 3007518363
- 3005674514
- 3013701115
- 1222928
- 3033519161
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases