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510(k) K792530

PLAQUE-X DENTURE CLEANER by Nexell Corp. — Product Code JER

K792530 is an FDA 510(k) premarket notification submitted by Nexell Corp. for the device "PLAQUE-X DENTURE CLEANER". The FDA issued a decision of Substantially Equivalent on December 27, 1979. 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
December 27, 1979
Date Received
December 7, 1979
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)
  • K832387 — DENTURE CLEANER (September 12, 1983)
  • K800166 — DENTSPLY DENTURE CLEANER (March 17, 1980)
  • K791925 — DEN-MAT 4-MINUTE DENTURE CLEANER (October 26, 1979)
  • K791716 — PLAQUE-X DENTURE CLEANSER (October 23, 1979)

FDA data resources