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510(k) K832387

DENTURE CLEANER by Tower Laboratories, Ltd. — Product Code JER

K832387 is an FDA 510(k) premarket notification submitted by Tower Laboratories, Ltd. for the device "DENTURE CLEANER". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code JER (Cleaner, Denture, Mechanical), a Class I device regulated under 21 CFR 872.3530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 19, 1983
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 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)
  • 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)
  • K791716 — PLAQUE-X DENTURE CLEANSER (October 23, 1979)

FDA data resources