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510(k) K062102

ODONCER by Teknimed, S.A. — Product Code LYC

K062102 is an FDA 510(k) premarket notification submitted by Teknimed, S.A. for the device "ODONCER". The FDA issued a decision of Substantially Equivalent on April 16, 2007. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Teknimed, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2007
Date Received
July 24, 2006
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 Teknimed, S.A.

  • K242216 — GENTAFIX® (1, 3, 3MV) (December 18, 2024)
  • K230394 — EUROSCREW NG; EUROSCREW TCP NG (May 12, 2023)
  • K161114 — HIGH V+ (April 12, 2017)
  • K103816 — COHESION BONE CEMENT (February 4, 2011)
  • K103433 — F20 (January 3, 2011)
  • K090435 — VERTECEM (December 21, 2009)
  • K083005 — NANGEL (March 4, 2009)
  • K080873 — OPACITY + BONE CEMENT (August 28, 2008)
  • K043593 — SPINE-FIX BIOMIMETIC BONE CEMENT (March 17, 2006)
  • K042911 — CEMENTEK LV (December 27, 2004)

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