S.I.N. Implant System Ltda.

Certificat C751660

Rév. 2Modifié

Valide jusqu'au: 4 déc. 2030

Le certificat C751660 est un certificat Système de management de la qualité valide délivré à S.I.N. Implant System Ltda. et enregistré dans EUDAMED. Valable jusqu'au 4 décembre 2030. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: C751660
Type de certificat: Système de management de la qualité
Statut du certificat: Modifié
Législation applicable: MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]
Version: 2
Identifiant du certificat: 2460C7516602

Validité

Délivré le: 10 juin 2026
Valide à partir du: 10 juin 2026
Valide jusqu'au: 4 déc. 2030

Organisme notifié

Organisme notifié: DNV Product Assurance AS
SRN de l'organisme notifié: 2460
Pays de l'organisme notifié: Norvège

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

Stérile: Oui
Tissus humains: Non
Tissus animaux: Non
Diagnostic in vitro: Non
Enregistrement initial: Non
Dispositif nouveau: Non
Élimination autorisée: Non
RSCP activé: Oui
Mécanisme de contrôle: Non
Destination médicale: Non
RSCP applicable: Non
Conditions applicables: Non
MOS hors EUDAMED: Non
Type SMQ/MOS: Classe IIb uniquement

Historique

Changements de statut

Modifié

Remplace

C751660Système de management de la qualitéDélivré5 déc. 2025 → 4 déc. 2030

Périmètre de couverture

Classe IIb18Classe IIa14

32 périmètres

The purpose is to replace missing, condemned teeth or conventional prostheses, with the aim of restoring aesthetics and masticatory function, stopping bone resorption and reducing overload on remaining teeth. They are based on the mechanical principles of load transmission system assembly.
Classe IIb
The purpose is to replace missing, condemned teeth or conventional prostheses, with the aim of restoring aesthetics and masticatory function, stopping bone resorption and reducing overload on remaining teeth. They are based on the mechanical principles of load transmission system assembly.
Classe IIb
The purpose is to replace missing teeth, condemned teeth or conventional prostheses, with the aim of recovering aesthetics and chewing function, curbing bone resorption and reducing the overload on remaining teeth. They are based on the mechanical principles of load transmission system assembly.
Classe IIb
The purpose is to replace missing, condemned teeth or conventional prostheses, with the aim of restoring aesthetics and masticatory function, stopping bone resorption and reducing overload on remaining teeth.
Classe IIb
Its purpose is to form the emergence profile for correct seating of the prosthesis, besides protecting the interior of the implant from intra-oral contamination. They are based on the principle of stabilization and epithelialization of the gum tissue.
Classe IIa
Its purpose is to form the emergence profile for correct seating of the prosthesis, besides protecting the interior of the implant from intra-oral contamination. They are based on the principle of stabilization and epithelialization of the gum tissue.
Classe IIa
It has the finality of forming the emergency profile for correct seating of the prosthesis, in addition to protecting the interior of the implant from intra-oral contamination.They are based on the principle of stabilization and epithelialization of gingival tissue.
Classe IIa
It has the finality of, together with the implant, transmitting the strength of mastication to the bone board, in which they are surgically implanted. The Interfaces are based on the mechanical principles of assembling the load transmission system.
Classe IIb
It has the purpose of fixing the prosthesis to the implant, and thus transmitting the chewing force to the bone plate, in which they are surgically implanted. The principle of operation is the combined effect of rotation and pressure. The torque force exerted on the distal (wider) end, with the help of the driver, is transferred throughout the component body, fixing the assembly on which the screw is inserted.
Classe IIb
It has the finality of, together with the implant, transmitting the strength of mastication to the bone board, in which they are surgically implanted. The Interfaces are based on the mechanical principles of assembling the load transmission system.
Classe IIb
Its purpose is to form a set with the implant and thus transmit the chewing forces to the bone board.They are based on the mechanical principles of assembling the load transmission system.The pre milled abutment is used for making dental protheses unitary, cemented oy screwed by the CAD-CAM system.
Classe IIb
Its purpose is, together with the implant, to transmit the force of mastication to the bone plate. They are based on the mechanical principles of load transmission system assembly.
Classe IIb
Drills without DLC and Drills with DLC
Classe IIa
Driver without DLC and Driver with DLC
Classe IIa
Screw Tap
Classe IIa
KIT Surgical Instruments
Classe IIa
DENTAL IMPLANTS WITHOUT HIDROXOPATITE IMPLANT TRYON – External Hexagon & Cone Morse Connection IMPLANT STRONG SW – External Hexagon, Internal Hexagon & Cone Morse Connection IMPLANT EPIKUT - External Hexagon & Cone Morse Connection
Classe IIb
DENTAL IMPLANTS WITH HIDROXOPATITE IMPLANT STRONG SW PLUS- External Hexagon, Internal Hexagon & Cone Morse Connection IMPLANT UNITITE-Cone Morse Connection IMPLANT EPIKUT PLUS–External Hexagon & Cone Morse Connection
Classe IIb
ZYGOMATIC DENTAL IMPLANTS WITHOUT HYDROXYAPATITE IMPLANT ZYGOMATIC - External Hexagon Connection
Classe IIb
ZYGOMATIC DENTAL IMPLANTS WITH HYDROXYAPATITE IMPLANT ZYGOMATIC PLUS - Cone Morse Connection
Classe IIb

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Documents

LanguesEN

Périmètre de couverture

Classe IIb18Classe IIa14

32 périmètres

The purpose is to replace missing, condemned teeth or conventional prostheses, with the aim of restoring aesthetics and masticatory function, stopping bone resorption and reducing overload on remaining teeth. They are based on the mechanical principles of load transmission system assembly.
Classe IIb
The purpose is to replace missing, condemned teeth or conventional prostheses, with the aim of restoring aesthetics and masticatory function, stopping bone resorption and reducing overload on remaining teeth. They are based on the mechanical principles of load transmission system assembly.
Classe IIb
The purpose is to replace missing teeth, condemned teeth or conventional prostheses, with the aim of recovering aesthetics and chewing function, curbing bone resorption and reducing the overload on remaining teeth. They are based on the mechanical principles of load transmission system assembly.
Classe IIb
The purpose is to replace missing, condemned teeth or conventional prostheses, with the aim of restoring aesthetics and masticatory function, stopping bone resorption and reducing overload on remaining teeth.
Classe IIb
Its purpose is to form the emergence profile for correct seating of the prosthesis, besides protecting the interior of the implant from intra-oral contamination. They are based on the principle of stabilization and epithelialization of the gum tissue.
Classe IIa
Its purpose is to form the emergence profile for correct seating of the prosthesis, besides protecting the interior of the implant from intra-oral contamination. They are based on the principle of stabilization and epithelialization of the gum tissue.
Classe IIa
It has the finality of forming the emergency profile for correct seating of the prosthesis, in addition to protecting the interior of the implant from intra-oral contamination.They are based on the principle of stabilization and epithelialization of gingival tissue.
Classe IIa
It has the finality of, together with the implant, transmitting the strength of mastication to the bone board, in which they are surgically implanted. The Interfaces are based on the mechanical principles of assembling the load transmission system.
Classe IIb
It has the purpose of fixing the prosthesis to the implant, and thus transmitting the chewing force to the bone plate, in which they are surgically implanted. The principle of operation is the combined effect of rotation and pressure. The torque force exerted on the distal (wider) end, with the help of the driver, is transferred throughout the component body, fixing the assembly on which the screw is inserted.
Classe IIb
It has the finality of, together with the implant, transmitting the strength of mastication to the bone board, in which they are surgically implanted. The Interfaces are based on the mechanical principles of assembling the load transmission system.
Classe IIb
Its purpose is to form a set with the implant and thus transmit the chewing forces to the bone board.They are based on the mechanical principles of assembling the load transmission system.The pre milled abutment is used for making dental protheses unitary, cemented oy screwed by the CAD-CAM system.
Classe IIb
Its purpose is, together with the implant, to transmit the force of mastication to the bone plate. They are based on the mechanical principles of load transmission system assembly.
Classe IIb
Drills without DLC and Drills with DLC
Classe IIa
Driver without DLC and Driver with DLC
Classe IIa
Screw Tap
Classe IIa
KIT Surgical Instruments
Classe IIa
DENTAL IMPLANTS WITHOUT HIDROXOPATITE IMPLANT TRYON – External Hexagon & Cone Morse Connection IMPLANT STRONG SW – External Hexagon, Internal Hexagon & Cone Morse Connection IMPLANT EPIKUT - External Hexagon & Cone Morse Connection
Classe IIb
DENTAL IMPLANTS WITH HIDROXOPATITE IMPLANT STRONG SW PLUS- External Hexagon, Internal Hexagon & Cone Morse Connection IMPLANT UNITITE-Cone Morse Connection IMPLANT EPIKUT PLUS–External Hexagon & Cone Morse Connection
Classe IIb
ZYGOMATIC DENTAL IMPLANTS WITHOUT HYDROXYAPATITE IMPLANT ZYGOMATIC - External Hexagon Connection
Classe IIb
ZYGOMATIC DENTAL IMPLANTS WITH HYDROXYAPATITE IMPLANT ZYGOMATIC PLUS - Cone Morse Connection
Classe IIb

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Certificat C751660

Aperçu

Validité

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Certificat C751660

Aperçu

Validité

Fabricant

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Fabricant