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510(k) K900507

DISPOSABLE SCREW TYPE PROPHY BRUSH by Dentsply Intl. — Product Code EHK

K900507 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "DISPOSABLE SCREW TYPE PROPHY BRUSH". The FDA issued a decision of Substantially Equivalent on April 10, 1990. The device falls under product code EHK (Cup, Prophylaxis), a Class I device regulated under 21 CFR 872.6290. Dentsply Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1990
Date Received
February 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cup, Prophylaxis
Device Class
Class I
Regulation Number
872.6290
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 EHK

  • K953628 — PROPHY ANGLE (September 29, 1995)
  • K951016 — DISPOSABLE PROPHYLAXIS ANGLE (May 2, 1995)
  • K864059 — DENTAL PROPHY CUPS (VARIOUS TYPES) (November 19, 1986)
  • K803155 — PROPHYLAXIS CUP. (January 8, 1981)
  • K790723 — PROPHYLAXIS CUPS AND POLISHERS (June 15, 1979)
  • K780198 — PROPHY CUPS, R&R (February 16, 1978)
  • K770556 — PRO-KUP (March 24, 1977)

FDA data resources