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510(k) K941431

BONE GRAFT DELIVERY SYRINGES by Bio-Interfaces, Inc. — Product Code EID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1994
Date Received
March 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Restorative And Impression Material
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Bio-Interfaces, Inc.

  • K960164 — BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140 (April 10, 1996)
  • K954763 — BIO-INTERFACES, INC,. BII-PLAST (January 4, 1996)
  • 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)
  • K933688 — BII-PORE (July 19, 1994)
  • K934049 — BII-PORE(TM) CANAL WALL PROSTHESIS (July 19, 1994)
  • K934430 — BON APATITE HA PARTICLES (May 18, 1994)
  • K934947 — BII-PLAST (January 26, 1994)
  • K924287 — 710 POROUS HA PARTICLES-BII-PORE (April 30, 1993)

Other clearances for product code EID

  • K913974 — ACCESS IMPRESSION BARREL (February 25, 1992)
  • K873153 — CAULK'S VPS CARTRIDGE SYSTEM (September 16, 1987)
  • K871937 — IMPRESSION SYRINGE (June 5, 1987)
  • K863998 — COLTENE JET-MIXER (October 30, 1986)
  • K853282 — CENTRIX RIBBON TUBES (August 23, 1985)
  • K851386 — UNITEK DISPOSABLE IMPRESSION SYRINGE (April 29, 1985)
  • K812680 — G-C IMPRESSION SYRINGE (October 6, 1981)
  • K812277 — PRISMA-FIL COMPULES (September 8, 1981)
  • K811582 — THE PLACER (July 28, 1981)
  • K781977 — APPLICATOR, LEE IMPRESSION (December 20, 1978)