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510(k) K030682

CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 by Bioform, Inc. — Product Code LYC

K030682 is an FDA 510(k) premarket notification submitted by Bioform, Inc. for the device "CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3". The FDA issued a decision of Substantially Equivalent on June 27, 2003. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Bioform, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2003
Date Received
March 5, 2003
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 Bioform, Inc.

  • K033398 — LARYNGEAL AUGMENTATION IMPLANT (December 12, 2003)
  • K013243 — COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 (January 9, 2002)
  • K012955 — COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER (October 22, 2001)

Other clearances for product code LYC

  • K253317 — Cytrans™ Elashield (July 6, 2026)
  • K253883 — Bonalive Maxillofacial (May 14, 2026)
  • K251818 — BONTREE PLUS (March 6, 2026)
  • 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)

FDA data resources