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510(k) K042931

TUF LINK SILICONE RELINER by Dentatus USA , Ltd. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2004
Date Received
October 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

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  • K961704 — MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM (July 26, 1996)

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