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510(k) K780254

DENTURE CLEANSER & TOOTHPASTE IN ONE by Richardson Merrel, Inc. — Product Code JER

K780254 is an FDA 510(k) premarket notification submitted by Richardson Merrel, Inc. for the device "DENTURE CLEANSER & TOOTHPASTE IN ONE". The FDA issued a decision of Substantially Equivalent on March 9, 1978. The device falls under product code JER (Cleaner, Denture, Mechanical), a Class I device regulated under 21 CFR 872.3530. Richardson Merrel, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1978
Date Received
February 16, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Denture, Mechanical
Device Class
Class I
Regulation Number
872.3530
Review Panel
DE
Submission Type

Other clearances by Richardson Merrel, Inc.

  • K790339 — CONCEPT II (July 17, 1979)

Other clearances for product code JER

  • K883403 — DENTA PLUS (October 25, 1988)
  • K881391 — ULTRASONIC DENTURE CLEANER (August 26, 1988)
  • K872521 — DENTURE CLEANSERS (August 11, 1987)
  • K852906 — DURACLEAN DENTURE CLEANER (July 31, 1985)
  • K840805 — ORAL SAFE (March 30, 1984)
  • K832359 — ORAL SAFE (September 26, 1983)
  • K832387 — DENTURE CLEANER (September 12, 1983)
  • K800166 — DENTSPLY DENTURE CLEANER (March 17, 1980)
  • K792530 — PLAQUE-X DENTURE CLEANER (December 27, 1979)
  • K791925 — DEN-MAT 4-MINUTE DENTURE CLEANER (October 26, 1979)

FDA data resources