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510(k) Data Aggregation
K Number
K022032Device Name
ACETAL
Manufacturer
INOVATIV, LLC
Date Cleared
2002-08-29
(69 days)
Product Code
EHP
Regulation Number
872.3285Why did this record match?
Product Code :
EHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.
Device Description
The Acetal material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
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K Number
K983558Device Name
ACETAL DENTAL/PREFORMED CLASP
Manufacturer
DENTAMAX, INC.
Date Cleared
1999-01-07
(86 days)
Product Code
EHP, OCT
Regulation Number
872.3285Why did this record match?
Product Code :
EHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fabrication of dental prostheses like: clasps on partial prostheses, provisional bridges, space maintainers, partials, active and passive aesthetic containing devices, and gnatological bites.
Device Description
Acetal Dental / Preformed Clasp
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K Number
K974622Device Name
DENTAL D
Manufacturer
MICRO DENTAL LABORATORIES
Date Cleared
1998-02-10
(61 days)
Product Code
EHP
Regulation Number
872.3285Why did this record match?
Product Code :
EHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fabrication of dental prostheses like: Clasps, provisional bridges, space maintainers, partials orthodontic devices and abutments.
Device Description
Not Found
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