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510(k) Data Aggregation
K Number
K080397Device Name
AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM
Manufacturer
Date Cleared
2008-05-06
(83 days)
Product Code
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DENTAL IMPLANT CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The American Dental Implant System is intended to be used in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients. As per Part 21, CFR 801 Subpart D, this item is for Prescription Use and as such is only sold on or by the order of a licensed dentist.
Device Description
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K Number
K042462Device Name
AMERICAN DENTAL IMPLANT
Manufacturer
Date Cleared
2004-09-21
(11 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DENTAL IMPLANT CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The American Dental Implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.
Device Description
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