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510(k) Data Aggregation
K Number
K972769Device Name
OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4
Manufacturer
OPTI-MAX
Date Cleared
1997-11-13
(112 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
OPTI-MAX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Opti-Max angled crown post for externally-hexed implants is intended to be used as an abutment for a cast crown, to be retained by cementation. The metal for this cast crown is to be composed of a computible formulation when in contact with Ti6A4V. If light retention is desired by the cinician zinc-oxide cement can be used, if stronger retention is desired, carboxylate cements of an be used. The cast crown seated on this crown post may be single and free-sanding, part of fixed bridgework, or connected to a bar structure for overdenture retention.
Device Description
Opti-Max Angled Crown Post for Externally-Hexed Implants
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K Number
K960022Device Name
OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS
Manufacturer
OPTI-MAX
Date Cleared
1996-05-24
(143 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
OPTI-MAX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955332Device Name
OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW
Manufacturer
OPTI-MAX
Date Cleared
1996-05-06
(168 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
OPTI-MAX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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