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510(k) K780198

PROPHY CUPS, R&R by Ransom and Randolph — Product Code EHK

K780198 is an FDA 510(k) premarket notification submitted by Ransom and Randolph for the device "PROPHY CUPS, R&R". The FDA issued a decision of Substantially Equivalent on February 16, 1978. The device falls under product code EHK (Cup, Prophylaxis), a Class I device regulated under 21 CFR 872.6290. Ransom and Randolph has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1978
Date Received
February 7, 1978
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 Ransom and Randolph

  • K781605 — R&R ABSORBENT POINTS (October 10, 1978)
  • K780399 — INSTRUMENT CLEANING BRUSH (March 17, 1978)
  • K780199 — PROPHY ANGLES, R&R (February 16, 1978)
  • K771347 — R&R ALSTON CARBIDE BURS (August 3, 1977)
  • K770598 — ENDODONTIC INSTRUMENTS, R&R CUTWELL (April 5, 1977)
  • K761067 — DENTSPLY DIE STONE (November 30, 1976)

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)
  • K803155 — PROPHYLAXIS CUP. (January 8, 1981)
  • K790723 — PROPHYLAXIS CUPS AND POLISHERS (June 15, 1979)
  • K770556 — PRO-KUP (March 24, 1977)

FDA data resources