510(k) K260564
- Device
- DESS Dental Smart Solutions
- Applicant
- Terrats Medical SL
- 510(k) number
- K260564
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-09
- Date received
- 2026-02-19
- 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
- N
Applicant Contact#
- Contact
- Roger Terrats
- Address
- Carrer Mogoda 75-99 Barbera Del Valles Barcelona ES 08210 08210
FDA Registration Numbers#
- 3008910197
- 3008186372
- 3001110146
- 2023950
- 1221541
- 8010591
- 1000625496
- 9617542
- 2523430
- 3012422333
- 3007031098
- 3014107733
- 3038715999
- 3008388248
- 3013034344
- 3004578807
- 3009325911
- 3031162123
- 9613662
- 3004883837
- 3003781339
- 2087481
- 9611992
- 2433919
- 1054986
- 3018097239
- 3011587077
- 3014290448
- 3042227762
- 3006540014
- 3000279043
- 3006411780
- 3006973441
- 3014142650
- 3012690648
- 3015383403
- 3016172557
- 1057425
- 3030089802
- 3013934196
- 1000244346
- 3008886124
- 3013111980
- 9612352
- 3005739655
- 3008088588
- 3010303805
- 3003310824
- 3006473685
- 3009496224
- 2183744
- 3031025053
- 3018077122
- 3007728094
- 3005674514
- 3004036186
- 3004417597
- 3011824442
- 1060818
- 9680939
- 3009779268
- 3016447764
- 3013547803
- 3012421607
- 3045005836
- 3017980266
- 9613866
- 3013578168
- 3007135442
- 3015218457
- 3012635238
- 3023852420
- 3035532393
- 3032802037
- 9614404
- 8043792
- 3009761487
- 3001617766
- 3030488649
Source Documents#
Other 510(k) Records For Product Code NHA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261327 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2026-09-30 |
| K262207 | Cemented Plus Abutment | Unidental Co., Ltd. | 2026-09-23 |
| K260940 | BellaTek Bars | ZimVie US Corp, LLC | 2026-09-21 |
| 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 |
| 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 |