Search Results
Found 1 results
510(k) Data Aggregation
K Number
K242217Device Name
Surcam Dental Implant System
Manufacturer
Date Cleared
2025-01-29
(184 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Surcam Medical Devices and Developments Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surcam Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The C Type 3.3mm diameter implants are indicated for use with only straight abutments.
Temporary cylinders must be used in a splinted restoration only and are not for single crown restorations.
Device Description
The Surcam Dental Implant System consists of endosseous dental implants in conical and internal hex connections along with abutments, cover screws, healing caps and abutment systems for each connection type. Conical devices come in two platforms, NP and RP. Implants and abutments are made from ASTM F136 Ti6AL4V ELI. Multi-unit abutments are for multi-unit restorations only.
Ask a Question
Ask a specific question about this device
Page 1 of 1