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510(k) K010775

BIOCELLECT by Imtec Corp. — Product Code LYC

K010775 is an FDA 510(k) premarket notification submitted by Imtec Corp. for the device "BIOCELLECT". The FDA issued a decision of Substantially Equivalent on June 12, 2001. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Imtec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2001
Date Received
March 14, 2001
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 Imtec Corp.

  • K081653 — MDI MII ONE-PIECE IMPLANT, 2.9MM (September 19, 2008)
  • K081347 — ILUMA VISION (May 28, 2008)
  • K072660 — ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 (December 12, 2007)
  • K053046 — ILUMA ORTHOCAT/DENTALCAT (November 8, 2005)
  • K043226 — ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 (January 13, 2005)
  • K042289 — MDI ORTHO (September 15, 2004)
  • K033432 — LEXATITE QUICK ACRYLIC (January 15, 2004)
  • K031106 — IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, M (August 12, 2003)
  • K030243 — ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 (April 23, 2003)
  • K024044 — SABER TECH IMPLANTS SYSTEM (February 21, 2003)

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