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510(k) K760657

RACESTYPTINE CORD by Septodont, Inc. — Product Code EIG

K760657 is an FDA 510(k) premarket notification submitted by Septodont, Inc. for the device "RACESTYPTINE CORD". The FDA issued a decision of Substantially Equivalent on September 27, 1976. The device falls under product code EIG (Retractor, All Types), a Class I device regulated under 21 CFR 872.4565. Septodont, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1976
Date Received
September 15, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, All Types
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Septodont, Inc.

  • 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)
  • K063634 — RTR SYRINGE (May 11, 2007)
  • 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)

Other clearances for product code EIG

  • K971284 — OPALDAM (June 3, 1997)
  • K854711 — FIBRELIGHT ILLUMINATING ORAL RETRACTORS (February 25, 1986)
  • K832366 — ZOLLER BURNED LIP CONFORMER (September 26, 1983)
  • K821784 — BEACH GINGIVAL RETRACTION INSTR. TYPE B (July 6, 1982)
  • K771973 — GINGITRACT (November 7, 1977)
  • K771399 — LIP & CHEEK RETRACTOR (August 26, 1977)
  • K761024 — RACESTYPTINE RINGS (November 19, 1976)

FDA data resources