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Found 7 results
510(k) Data Aggregation
K Number
K992512Device Name
ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA
Manufacturer
IMCOR
Date Cleared
1999-11-01
(97 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMCOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Altiva implant sizes are for widths 3.3mm, 4.00mm, and 5.00mm. All widths come in lengths of 10mm, 11.5mm, 13mm and 15mm.
Altiva implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The Altiva implants can be placed with or without tissue reflection.
The Altiva Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The Altiva Implant is designed to be placed in immediate function with a temporary.
All components are to be used as labeled. Components are not intended to be bent by the clinician.
Device Description
Altiva Immediate Function Dental Implant
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K Number
K983563Device Name
IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I
Manufacturer
IMCOR
Date Cleared
1999-01-11
(90 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMCOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMCOR implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients.
The IMCOR Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR implant is the same as currently accepted uses for dental implants already in the marketplace.
All components are to be used as labeled. Components are not intended to be bent by the clinician.
Device Description
Not Found
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K Number
K982492Device Name
IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES
Manufacturer
IMCOR
Date Cleared
1998-10-15
(90 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMCOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMCOR implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The cover screw is used to protect the top of the implant and the internal threads during the healing process.
The IMCOR Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR implant is the same as currently accepted uses for dental implants already in the marketplace.
All components are to be used as labeled. Components are not intended to be bent, cast or altered by the clinician.
Device Description
Not Found
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K Number
K974126Device Name
IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW
Manufacturer
IMCOR
Date Cleared
1998-01-30
(88 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMCOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMCOR implants are indicated to replace missing tooth roots for single tooth, partial and fully edentulous patients. The cover screw is used to protect the top of the implant and the internal threads during the healing process. The IMCOR Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR implant is the same as currently accepted uses for dental implants already in the marketplace. All components are to be used as labeled. Components are not intended to be bent, cast or altered by the clinician.
Device Description
Not Found
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K Number
K973049Device Name
IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM
Manufacturer
IMCOR
Date Cleared
1997-11-13
(90 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMCOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMCOR™ implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The cover screw is used to protect the top of the implant and the internal threads during the healing process. The surgical drills are intended to be used to create the osteotomy for placement of the dental implant.
The IMCOR™ Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR™ implant and restorative system is the same as currently accepted uses for dental implants already in the marketplace.
All components are to be used as labeled. Components are not intended to be bent, cast or altered by the clinician.
Device Description
Not Found
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K Number
K960899Device Name
IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW
Manufacturer
IMCOR
Date Cleared
1996-06-17
(104 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMCOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960900Device Name
IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW
Manufacturer
IMCOR
Date Cleared
1996-06-05
(92 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMCOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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