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510(k) K761275

AIROTOS LF HANDPIECE by Dentsply Intl. — Product Code DZA

K761275 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "AIROTOS LF HANDPIECE". The FDA issued a decision of Substantially Equivalent on December 23, 1976. The device falls under product code DZA (Drill, Dental, Intraoral), a Class I device regulated under 21 CFR 872.4130. Dentsply Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1976
Date Received
December 20, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Dental, Intraoral
Device Class
Class I
Regulation Number
872.4130
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 DZA

  • K984508 — SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/ (June 25, 1999)
  • K962979 — S-53 INTRORAL DENTAL SYSTEM (September 25, 1996)
  • K954790 — PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS (January 16, 1996)
  • K914724 — ADA SHANK EXTENSION (July 27, 1993)
  • K905418 — GATES GLIDDEN DRILLS (July 25, 1991)
  • K901097 — FILLOCK REAMER (April 25, 1990)
  • K896149 — ANEST-EZE DENTAL DRILL RA#2 (January 19, 1990)
  • K884187 — INDENTEC DRILL RA #1 (December 22, 1988)
  • K811113 — RIESS-LUHR (June 16, 1981)
  • K801888 — HANDPIECE, DENTAL (August 20, 1980)

FDA data resources