510(k) K130618
- Device
- SFI-ANCHOR
- Applicant
- CENDRES & METAUX SA
- 510(k) number
- K130618
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-03-03
- Date received
- 2013-03-07
- 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
- TANJA BONGNI
- Address
- Rue De Boujean 122 Biel/Bienne CH 2501 2501
FDA Registration Numbers#
- 3007689689
- 3007515069
- 3015456817
- 3008812251
- 3013701115
- 9613953
- 3009482100
- 3024852742
- 1000577893
- 3007740664
- 3016733895
- 3007529467
- 1627417
- 3009201148
- 3006540014
- 3003618527
- 3025338240
- 3007233968
- 3006473685
- 3012354669
- 3004730368
- 3016954909
- 3010251542
- 3017833095
- 3027665899
- 3019793783
- 9680939
- 2087481
- 3014843857
- 3032802037
- 3005663340
- 3034686762
- 3018501314
- 3014112268
- 3010869261
- 3014118611
- 3021076825
- 9617542
- 3009514134
- 3013527433
- 3017013344
- 1226544
- 8043971
- 3003477135
- 2032098
- 3005126636
- 3045005836
- 3012187973
- 9614977
- 3013173272
- 3002807310
- 2523430
- 3007218081
- 9681199
- 9613348
- 3013111692
- 9613866
- 9613283
- 3008870565
- 3001110146
- 3003394627
- 3008517893
- 3005115116
- 3009840806
- 3005739655
- 1000461041
- 3002963873
- 3011656326
- 1000244346
- 3035532394
- 3007597023
- 3010363503
- 1222315
- 1526534
- 3006973441
- 2918719
- 3013960655
- 3030255892
- 3004748290
- 3002808227
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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