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510(k) K994205

MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM by Lifecore Biomedical, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2000
Date Received
December 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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  • K062876 — PRIMACONNEX CERAMIC ABUTMENTS (November 1, 2006)
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  • K053643 — STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 (January 23, 2006)
  • K051614 — PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION (September 9, 2005)
  • K050506 — PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS (April 15, 2005)
  • K041324 — CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER (July 19, 2004)

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