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510(k) K881391

ULTRASONIC DENTURE CLEANER by Tatung Company of America, Inc. — Product Code JER

K881391 is an FDA 510(k) premarket notification submitted by Tatung Company of America, Inc. for the device "ULTRASONIC DENTURE CLEANER". The FDA issued a decision of Substantially Equivalent on August 26, 1988. The device falls under product code JER (Cleaner, Denture, Mechanical), a Class I device regulated under 21 CFR 872.3530. Tatung Company of America, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1988
Date Received
April 4, 1988
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 Tatung Company of America, Inc.

  • K874805 — TATUNG'S DENTURE CLEANING SOLUTION (February 16, 1988)

Other clearances for product code JER

  • K883403 — DENTA PLUS (October 25, 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)
  • K791716 — PLAQUE-X DENTURE CLEANSER (October 23, 1979)

FDA data resources