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510(k) K951016

DISPOSABLE PROPHYLAXIS ANGLE by Preventive Technologies, Inc. — Product Code EHK

K951016 is an FDA 510(k) premarket notification submitted by Preventive Technologies, Inc. for the device "DISPOSABLE PROPHYLAXIS ANGLE". The FDA issued a decision of Substantially Equivalent on May 2, 1995. The device falls under product code EHK (Cup, Prophylaxis), a Class I device regulated under 21 CFR 872.6290. Preventive Technologies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1995
Date Received
March 6, 1995
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 Preventive Technologies, Inc.

  • K140350 — VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL (December 12, 2014)
  • K100539 — PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (June 17, 2010)

Other clearances for product code EHK

  • K953628 — PROPHY ANGLE (September 29, 1995)
  • K900507 — DISPOSABLE SCREW TYPE PROPHY BRUSH (April 10, 1990)
  • 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