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510(k) K921776

1840 HA PARTICLES by Bio-Interfaces, Inc. — Product Code LYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1992
Date Received
April 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Grafting Material, Synthetic
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.

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)
  • 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)

Other clearances for product code LYC

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  • K244006 — FG Bone Graft M (September 17, 2025)
  • K243745 — FG Bone Graft B (August 29, 2025)
  • K241186 — Synthetic Bone Graft Particulate (February 21, 2025)
  • K213260 — CMFlexTM (December 30, 2022)
  • K202675 — InRoad® Dental Synthetic Bone Graft (March 4, 2022)
  • K201546 — OsOpia Synthetic Bone Void Filler (October 2, 2020)
  • K201051 — Straumann BoneCeramic (September 24, 2020)
  • K192597 — Cytrans Granules (August 17, 2020)
  • K153676 — OSTEON III (September 14, 2016)