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510(k) Data Aggregation
K Number
K972351Device Name
SENDAX MDI (MINI DENTAL IMPLANT)
Manufacturer
SENDAX MDIC MANAGEMENT, INC.
Date Cleared
1997-11-24
(153 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SENDAX MDIC MANAGEMENT, INC.
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 applications, to permit immediate splinting stability and ongoing fixation of new or existing crown & bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention.
Representative applications include the following:
- t Temporary (transitional) supports for fixed or removable implant-supported prostheses while conventional implants are integrating .
- * Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes Ox integrating implants.
- 本 Introductory system for nervous or apprehensive potential implant patients, offering a simple methodology for testing out the actual "feel" of boneanchored implants, without the major committment to final restorations; or as an interim system for medically compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication & general well-being, at modest cost levels.
Device Description
Self-capping citanium threaded screw, 1.8mm in width by 14,17,19,&22mm lengchs
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