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CAMLOG Ceramic Abutment - SFDA Registration ME0000001463SFDAA00063

Access comprehensive regulatory information for CAMLOG Ceramic Abutment in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIb device is registered with Saudi Arabia SFDA under registration number ME0000001463SFDAA00063 and manufactured by ALTATEC GmbH.

This page provides complete registration details including product category (Medical Device), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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Class IIb
ME0000001463SFDAA00063
CAMLOG Ceramic Abutment
SFDA Registration: ME0000001463SFDAA00063
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Product Information

device connected to the dental implant and aids in prosthetic rehabilitation

Product Use

The ceramic abutment represents a 2-part abutment and consists of a titanium base and a zirconium oxide sleeve. It is intended to be used for individual mesostructures for crown and bridge restorations in esthetically critical zones. The product is used in the maxilla and mandible of the partial or fully edentulous patient. Zirconium oxide distinguishes itself by an extremely high strength and hardness. The titanium base is equipped with the CAMLOGยฎ Tube-in-Tubeโ„ข connection and thus ensures a high precision fit to the implant. The zirconium oxide sleeve can be individually ground and is used as the mesostructure for the final crown or bridge restoration. Optionally, the zirconium oxide sleeve can directly veneered with appropriate ceramic materials to fabricate an all-ceramic crown. Only after processing or veneering is the sleeve bonded finally to the screwed titanium base. Thus, the titanium base is not exposed to any thermal influences.

Device Classification
Risk Class
Class IIb
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000001463SFDAA00063
Authorization ID
GHTF-2019-0518
Status
Active
Expire Date
June 29, 2022
Manufacturer
Manufacturer Name
ALTATEC GmbH
Model Information
Model ID(s)
K2242.3340 K2242.3840 K2242.4340 K2242.5040 K2242.6040 K2242.3342 K2242.3842 K2242.4342 K2242.5042 K2242.6042
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