Home / 510(k) Clearances / K923586

510(k) K923586

BURNOUT MATERIAL by Dentsply Intl. — Product Code EGD

K923586 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "BURNOUT MATERIAL". The FDA issued a decision of Substantially Equivalent on September 29, 1992. The device falls under product code EGD (Wax, Dental, Intraoral), a Class I device regulated under 21 CFR 872.6890. Dentsply Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1992
Date Received
July 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wax, Dental, Intraoral
Device Class
Class I
Regulation Number
872.6890
Review Panel
DE
Submission Type

Other clearances by Dentsply Intl.

  • K140347 — ANKYLOS C/X IMPLANT SYSTEM (August 20, 2014)
  • K130862 — CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM (July 23, 2013)
  • K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC (February 22, 2013)
  • K103244 — QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION (February 14, 2011)
  • K093221 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II (October 30, 2009)
  • K083805 — ANKYLOS C/X DENTAL IMPLANT SYSTEM (May 22, 2009)
  • K082198 — DURASHIELD PLUS (October 29, 2008)
  • K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS (March 27, 2008)
  • K072989 — AXIS SYSTEM (January 28, 2008)
  • K073117 — DENTIN DESENSITIZER AGENT (December 19, 2007)

Other clearances for product code EGD

  • K020009 — BRACE EZE (February 11, 2002)
  • K945535 — GLENROE ORTHO-SIL (January 27, 1995)
  • K924024 — ORTHO WAX (November 17, 1992)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K922380 — BITE RIM WAX (June 16, 1992)
  • K914513 — PALAVIT G (March 19, 1992)
  • K910676 — INTRAORAL DENTAL WAX (August 21, 1991)
  • K904928 — PALAVIT GLC (June 6, 1991)
  • K895563 — PEMACO BITE WAX SHEETS (November 6, 1989)
  • K895566 — PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT (November 6, 1989)

FDA data resources