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510(k) Data Aggregation
K Number
K130476Device Name
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
Manufacturer
Date Cleared
2014-01-08
(317 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DENTAL MORELLI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dental Morelli Orthodontic Dental Implant is a threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
Device Description
The Orthodontic Miniscrew for Absolute Anchorage is an implantable medical device used as a temporary skeletal anchorage point for orthodontic movements. The mini screw is intended to receive low intensity static clinical loads. Maximum dynamic forces may occur at low frequencies for short periods; which is inadequate to compromise the performance of the product through fatigue. The device is available in different lengths (6, 8, 10, mm), diameter 1.5 mm, and supplied in sealed sterile polyethylene bags.
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K Number
K131197Device Name
EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
Manufacturer
Date Cleared
2013-08-27
(123 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
DENTAL MORELLI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Device Description
Edgewise and Roth Ceramic Brackets are intended to be bonded to teeth, upon which an orthodontic wire is used to move the teeth to new positions. The Morelli bracket consists of a translucent alumina body. The bracket is uncoated. The Morelli bracket is not self-bonding and requires a primer and adhesive to bond the bracket to the teeth.
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