510(k) K151608
- Device
- 4plus6Line Abutment System
- Applicant
- OT MEDICAL GMBH
- 510(k) number
- K151608
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-04-13
- Date received
- 2015-06-15
- 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
- Martina Behlau
- Address
- Konsul-Smidt-Str. 8b Bremen DE D-28217 D-28217
FDA Registration Numbers#
- 3004203816
- 3015456817
- 3017125693
- 3012481042
- 3011390931
- 1627417
- 3013934196
- 2133778
- 1423662
- 3033519161
- 3008309654
- 3012187973
- 3004730368
- 3017980266
- 3009325911
- 3007362683
- 3009840806
- 3031162123
- 3012422333
- 2244478
- 3026365523
- 3010876315
- 3005409899
- 9613348
- 3009687180
- 8010516
- 3017548645
- 3010303805
- 1036836
- 3005115116
- 3009528826
- 3008693672
- 3013111980
- 3004711948
- 3010869261
- 3031303433
- 3043585140
- 2183828
- 3006411780
- 3030089802
- 3004556094
- 1222802
- 2918719
- 2183744
- 3010363503
- 3016954909
- 3013701115
- 3012421607
- 3016447764
- 3004443656
- 3007740664
- 3010948854
- 3024858450
- 3007521935
- 3024852742
- 3014107733
- 3008186372
- 3009196578
- 3015160953
- 3024859204
- 1410097
- 3015218457
- 3040978916
- 3013264549
- 3008910197
- 3010287685
- 2921595
- 3014938434
- 3026444199
- 3035532394
- 3009847764
- 3033524692
- 2219920
- 8044131
- 3008261720
- 3033781108
- 3031886796
- 3008496301
- 1054986
- 3021630667
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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