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510(k) K832919

OPTI-BEAM IV by Dentsply Intl. — Product Code EAZ

K832919 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "OPTI-BEAM IV". The FDA issued a decision of Substantially Equivalent on March 2, 1984. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Dentsply Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1984
Date Received
August 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Operating, Dental
Device Class
Class I
Regulation Number
872.4630
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 EAZ

  • K072309 — MICROLUX/BLU (November 19, 2007)
  • K041614 — MICROLUX DL (April 4, 2005)
  • K033033 — VIZILITE-BLUE ORAL EXAM KIT (November 22, 2004)
  • K003995 — SPECULITE/ORALLITE (March 16, 2001)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K935390 — SIROLUX FANTASTIC (December 10, 1993)
  • K925629 — ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (November 23, 1993)
  • K923462 — DELIGHT (December 21, 1992)
  • K912142 — MICRONAIRE ISO-HOOD MAX 5UV (October 30, 1991)
  • K912997 — MINIFLEX AND PERSONAL UNIT (October 30, 1991)

FDA data resources