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510(k) Data Aggregation
K Number
K981182Device Name
OSTEOGRAF/N-300
Manufacturer
CERAMED DENTAL, LLC.
Date Cleared
1998-07-02
(92 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
CERAMED DENTAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of OsteoGraf/N-300 is for:
- Treatment of infrabony periodontal defects. .
- Augmentation of bony defects of the alveolar ridge. ●
- Filling of extraction sites.
- Sinus elevation grafting ●
Device Description
OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite. the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.
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K Number
K981214Device Name
OSTEOGRAF/N-700
Manufacturer
CERAMED DENTAL, LLC.
Date Cleared
1998-06-26
(85 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
CERAMED DENTAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of OsteoGraf/N-700 is for:
- Treatment of infrabony periodontal defects.
- Augmentation of bony defects of the alveolar ridge.
- Filling of extraction sites.
- Sinus elevation grafting.
Device Description
OsteoGraf/N-700 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 420-1000 microns.
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