510(k) K230218
- Device
- DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
- Applicant
- Dental Direkt GmbH
- 510(k) number
- K230218
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-25
- Date received
- 2023-01-26
- 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
- Patrick Berz
- Address
- Industriezentrum 106-108 Spenge DE 32139 32139
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 |