510(k) K222269
- Device
- DESS Dental Smart Solutions
- Applicant
- Terrats Medical SL
- 510(k) number
- K222269
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-26
- Date received
- 2022-07-28
- 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
- Roger Terrats
- Address
- Carrer Mogoda 75-99 Barberá Del Vallés ES 08210 08210
FDA Registration Numbers#
- 3024852742
- 3012422333
- 3006948193
- 1226544
- 3009217531
- 3010392243
- 3031462380
- 3019793783
- 9613662
- 3013934196
- 3016172557
- 3011891801
- 2433919
- 8031058
- 1038806
- 3015194291
- 3001295407
- 3012690648
- 3004417597
- 3010162973
- 3027494823
- 3011545243
- 3024859204
- 3009528809
- 1000244346
- 2087481
- 9681199
- 3013701115
- 3007536957
- 3011461101
- 3005383085
- 3012106319
- 3004884150
- 3038136479
- 3008309654
- 3036779616
- 8020776
- 3035532393
- 3017125693
- 3031553803
- 3011936113
- 3003394081
- 3006411780
- 3019252621
- 9613866
- 3032439351
- 3006110126
- 3009496224
- 3011276344
- 3005952241
- 3013578168
- 1222315
- 9612300
- 3004638532
- 3005497913
- 3014290448
- 3031303433
- 3006017180
- 3006473685
- 3003394627
- 3011808221
- 1222928
- 3007728094
- 3008494722
- 3005941719
- 3005115116
- 3007518363
- 3005730680
- 3008770646
- 3009201148
- 3006540014
- 1036836
- 3013111980
- 3038549074
- 1060818
- 3002963873
- 3011221537
- 3001617766
- 3012421607
- 3005663340
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#
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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