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510(k) K072058

MODIFICATION TO: OSTEOGRAF/N-700 by Dentsply Interntional — Product Code LYC

K072058 is an FDA 510(k) premarket notification submitted by Dentsply Interntional for the device "MODIFICATION TO: OSTEOGRAF/N-700". The FDA issued a decision of Substantially Equivalent on August 3, 2007. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Dentsply Interntional has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2007
Date Received
July 26, 2007
Clearance Type
Special
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 Dentsply Interntional

  • K092614 — X-SMART EASY (December 2, 2009)
  • K092030 — ELATION MB METAL REINFORCED PLASTIC BRACKET (July 24, 2009)
  • K090454 — ALLURE MB CERAMIC BRACKETS (March 20, 2009)
  • K082973 — STER-MATE STERILE LAVAGE KIT (January 29, 2009)
  • K082974 — MYSTIQUE MB CERAMIC BRACKETS (November 7, 2008)
  • K081291 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION (May 22, 2008)
  • K080311 — MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM (April 18, 2008)
  • K080246 — COMPOSITE ALIGNER BUTTON (April 11, 2008)
  • K080203 — MTA ROOT CANAL SEALER (March 26, 2008)
  • K073173 — SELF-ADHESIVE RESIN CEMENT (January 23, 2008)

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