FDA.report

510(k) K253804

Device
DESS Dental Smart Solutions
Applicant
Terrats Medical SL
510(k) number
K253804
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-16
Date received
2025-11-28
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
N

Related Records

Applicant Contact

Contact
Roger Terrats
Address
Carrer Mogoda 75-99 Barbera Del Valles Barcelona ES 08210 08210

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K260555LOCATOR® Angled AbutmentZest Anchors, LLC2026-04-09
K251434Healing Abutment SystemOsstem Implant Co., Ltd.2026-03-04
K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley2026-02-10
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K253315Straumann Variobase Abutments XC for Bridge/BarInstitut Straumann AG2026-01-22
K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.2026-01-22
K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.2026-01-07
K253341Custom Abutments ASMedentika GmbH2025-12-23
K253312OrangeCAD Med AbutmentsOrangecad Med GmbH2025-12-23
K252320SIMDA AbutmentsSimda Co., Ltd.2025-12-18
K252343Atlantis® Abutments in TitaniumDentsply Sirona2025-12-09
K252248CEREC Tessera Abutment SystemDentsply Sirona2025-11-26