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510(k) Data Aggregation
K Number
K012681Device Name
ANKYLOS
Manufacturer
DENTSPLY CERAMCO
Date Cleared
2003-08-22
(738 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY CERAMCO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants
Device Description
Ankylos dental implants consist of uncoated pure titanium (grade 2 per ISO 5832/II). The threaded area features a rough structure, the cervical margin is polished. The implants come packaged in a sterile double glass container for contact-free handling. The cover screw has already been mounted in the implant and is only removed prior to placing the abutment.
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