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510(k) K871909

COMPOSITE RESTORATIVE CARRIER by Dentsply Intl. — Product Code EIY

K871909 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "COMPOSITE RESTORATIVE CARRIER". The FDA issued a decision of Substantially Equivalent on May 27, 1987. The device falls under product code EIY (Instrument, Filling, Plastic, Dental), a Class I device regulated under 21 CFR 872.4565. Dentsply Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1987
Date Received
May 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Filling, Plastic, Dental
Device Class
Class I
Regulation Number
872.4565
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 EIY

  • K851726 — 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN (July 2, 1985)
  • K833955 — NOVEL DISPENSER/PACKAGE (January 3, 1984)
  • K830776 — MICROFIL CONTOURING INSTRUMENTS (April 28, 1983)
  • K823323 — DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS (November 24, 1982)

FDA data resources