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510(k) K803155

PROPHYLAXIS CUP. by Teledyne Densco — Product Code EHK

K803155 is an FDA 510(k) premarket notification submitted by Teledyne Densco for the device "PROPHYLAXIS CUP.". The FDA issued a decision of Substantially Equivalent on January 8, 1981. The device falls under product code EHK (Cup, Prophylaxis), a Class I device regulated under 21 CFR 872.6290. Teledyne Densco has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1981
Date Received
December 12, 1980
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 Teledyne Densco

  • K821686 — DENSCO PROPHY ANGLE (June 25, 1982)
  • K821364 — PROFLEX FLEXIBLE SCALER (May 28, 1982)
  • K780641 — DENTAL ROTARY CARBIDE BURS 76EJL (April 21, 1978)

Other clearances for product code EHK

  • K953628 — PROPHY ANGLE (September 29, 1995)
  • K951016 — DISPOSABLE PROPHYLAXIS ANGLE (May 2, 1995)
  • K900507 — DISPOSABLE SCREW TYPE PROPHY BRUSH (April 10, 1990)
  • K864059 — DENTAL PROPHY CUPS (VARIOUS TYPES) (November 19, 1986)
  • 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