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510(k) Data Aggregation
K Number
K954758Device Name
ROOTFORM DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
1997-08-18
(672 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SWISS DENTAL CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rootform Dental Implant is an endosseous dental implant intended to provide support for prosthetic attachments. The Rootform Dental Implant is surgically placed in the bone of the upper or lower jaw arches to provide attachment and support for an abetment and prosthetic devices including artificial teeth, bridges, and dentures.
Device Description
The Rootform Dental Implant System has two "families" -- one without a hex top with 3.3 mm and 3.8 mm diameter cylinders and a second with a hex lock top with 3.3 mm and 4.0 mm diameters.
The components of each system are as follows:
Rootform 3.3 mm and 3.8 mm Non-Hex Top Implant System
- Implants with internal thread
- Cover screws
- Healing abutments
- Prepable abutments
- Bar or tissue abutments
- Abutment screws
- Tissue abutment with cap
- Prosthetic attachment screws
Rootform 3.3 mm and 4.0 mm Universal Hex Top Implant System
- Implants with internal thread
- Cover screws
- Fixation screws
- Healing abutments
- Straight abutments
- Angled abutments
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