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510(k) K063634

RTR SYRINGE by Septodont — Product Code LYC

K063634 is an FDA 510(k) premarket notification submitted by Septodont for the device "RTR SYRINGE". The FDA issued a decision of Substantially Equivalent on May 11, 2007. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Septodont has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2007
Date Received
December 6, 2006
Clearance Type
Abbreviated
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 Septodont

  • K212283 — BioRoot Flow 0.5g, BioRoot Flow 2g (September 16, 2021)
  • K211799 — Biodentine XP 500, Biodentine XP 200 (August 10, 2021)
  • K172839 — ENDOSOLV (February 13, 2018)
  • K140132 — BIODENTINE (June 27, 2014)
  • K093711 — RACEGEL (February 17, 2010)
  • K092251 — BIODENTINE (October 30, 2009)
  • K051010 — SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (May 2, 2005)
  • K032708 — PLASTALGIN AND PLASTALGIN ORTHO (November 20, 2003)
  • K023976 — ACROSEAL ROOT CANAL OR APICAL SEALER (January 30, 2003)
  • K780003 — ENDOSOLV E (January 20, 1978)

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