S.I.N. Implant System Ltda.

Certificate C751660

Rev. 2Amended

Valid until: Dec 4, 2030

Certificate C751660 is a valid Quality management system issued to S.I.N. Implant System Ltda. and registered in EUDAMED. Valid until December 4, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: C751660
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 2460C7516602

Validity

Issued: Jun 10, 2026
Valid from: Jun 10, 2026
Valid until: Dec 4, 2030

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Amended

Supersedes

C751660Quality management systemIssuedDec 5, 2025 → Dec 4, 2030

Scope coverage

Class IIb18Class IIa14

32 scopes

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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class IIb
Drills without DLC and Drills with DLC
Class IIa
Driver without DLC and Driver with DLC
Class IIa
Screw Tap
Class IIa
KIT Surgical Instruments
Class 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
Class 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
Class IIb
ZYGOMATIC DENTAL IMPLANTS WITHOUT HYDROXYAPATITE IMPLANT ZYGOMATIC - External Hexagon Connection
Class IIb
ZYGOMATIC DENTAL IMPLANTS WITH HYDROXYAPATITE IMPLANT ZYGOMATIC PLUS - Cone Morse Connection
Class IIb

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Documents

LanguagesEN

Scope coverage

Class IIb18Class IIa14

32 scopes

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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class 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.
Class IIb
Drills without DLC and Drills with DLC
Class IIa
Driver without DLC and Driver with DLC
Class IIa
Screw Tap
Class IIa
KIT Surgical Instruments
Class 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
Class 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
Class IIb
ZYGOMATIC DENTAL IMPLANTS WITHOUT HYDROXYAPATITE IMPLANT ZYGOMATIC - External Hexagon Connection
Class IIb
ZYGOMATIC DENTAL IMPLANTS WITH HYDROXYAPATITE IMPLANT ZYGOMATIC PLUS - Cone Morse Connection
Class IIb

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Certificate C751660

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate C751660

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer