510(k) K142890
- Device
- Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS E.max CAD MO Coping, IPS E.max CAD LT Crown, IPS E.max CAD HT Crown, Coron CoCr
- Applicant
- STRAUMANN USA, LLC
- 510(k) number
- K142890
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-09
- Date received
- 2014-10-03
- 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
- Jennifer M. Jackson
- Address
- 60 Minuteman Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 3009848796
- 3009217531
- 3005497913
- 3011891801
- 1054986
- 3005597557
- 3010251542
- 3011461101
- 3038549074
- 1038806
- 3013111692
- 1226544
- 3005106408
- 1223843
- 2921595
- 1000461041
- 3018662547
- 3003477135
- 3023535580
- 3015456817
- 3017833095
- 3017013344
- 3009727738
- 3005121682
- 2219920
- 3023878501
- 3009779268
- 3013960456
- 3003847101
- 3010407203
- 3031303433
- 3009432160
- 3021630667
- 3017450159
- 3024859204
- 3005126636
- 3010610960
- 1423662
- 3003394081
- 3015160953
- 3026444199
- 8044131
- 1222928
- 3006540014
- 9617542
- 3039397999
- 3009737865
- 3013034344
- 3031162123
- 3013376795
- 3005643710
- 3007126709
- 3016099073
- 3032439351
- 3014270094
- 3033519161
- 3009201148
- 1000244346
- 2024024
- 3031553803
- 3013950969
- 3010393542
- 3021076825
- 3013551048
- 3004201263
- 3010730876
- 3007515069
- 3004638532
- 3012121192
- 3008252251
- 3007529467
- 2436986
- 3013701115
- 3002963873
- 3014270103
- 3008910197
- 3011936113
- 3002807310
- 3030089802
- 3024185724
Source Documents#
Other 510(k) Records For Product Code NHA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB | 2026-08-06 |
| 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 |
Legacy Summary#
summary
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