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510(k) K884732

SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM by Bio-Interfaces, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1989
Date Received
November 10, 1988
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

Other clearances by Bio-Interfaces, Inc.

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  • K950598 — BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT (August 23, 1995)
  • K950567 — BIO-APATITE 6140 HA PARTICLES (May 9, 1995)
  • K950511 — BLL-FIL 6140 PARTICLES (April 27, 1995)
  • K934049 — BII-PORE(TM) CANAL WALL PROSTHESIS (July 19, 1994)
  • K933688 — BII-PORE (July 19, 1994)
  • K941431 — BONE GRAFT DELIVERY SYRINGES (July 12, 1994)
  • K934430 — BON APATITE HA PARTICLES (May 18, 1994)
  • K934947 — BII-PLAST (January 26, 1994)

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