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510(k) K040646

STRAUMANN GRANULES by The Straumann Co. — Product Code LYC

K040646 is an FDA 510(k) premarket notification submitted by The Straumann Co. for the device "STRAUMANN GRANULES". The FDA issued a decision of Substantially Equivalent on May 3, 2004. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. The Straumann Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2004
Date Received
March 11, 2004
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 The Straumann Co.

  • K041070 — STRAUMANN TEMPORARY COPING (July 23, 2004)
  • K040469 — THE STRAUMANN ORTHO IMPLANT SYSTEM (April 30, 2004)
  • K993862 — MODUS SAGITTAL SPLIT PLATE (December 29, 1999)
  • K962023 — PLASTIC PROTECTION HEALING CAPS (August 15, 1996)
  • K960634 — TITANIUM HEALING CAPS (June 18, 1996)
  • K955281 — ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES (March 15, 1996)
  • K955369 — MEMFIX (January 23, 1996)
  • K941393 — ITI ANGLED ABUTMENT (June 14, 1995)
  • K943720 — ITI TRANSVERSAL SCREWING SYSTEM (March 24, 1995)
  • K931993 — ITI DISTANCE SYSTEM (April 26, 1994)

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