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510(k) Data Aggregation
K Number
K990983Device Name
MODIFICATION TO IMTEC SENDAX MDI
Manufacturer
IMTEC CORP.
Date Cleared
1999-04-13
(20 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
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Matched: '872.3890'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a self- tapping titanium threaded screw indicated for intra-bony and inter-radicular transitional application, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge instillations, for full or partial edentulism, an employing minimally invasive surgical intervention.
Representative applications include the following:
- * Temporary (transitional supports for fixed or removable implant-supported prosthesies while conventional implants are integrating.
- * Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes or integrating implants.
- * Introductory system for nervous or apprehensive potential patients, offering a simple methodology for testing out the actual "feel of bone anchored implants, without the major commitment to final restorations; or as an interim system for medical compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication and general well-being, at modest cost levels.
Device Description
Self-tapping titanium screw, 1.8 mm in width by 13, 15and 18 mm lengths.
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K Number
K961704Device Name
MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM
Manufacturer
DENTATUS USA, LTD.
Date Cleared
1996-07-26
(85 days)
Product Code
ELS
Regulation Number
872.3890Why did this record match?
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Matched: '872.3890'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
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