Home / 510(k) Clearances / K791925

510(k) K791925

DEN-MAT 4-MINUTE DENTURE CLEANER by Den-Mat Corp. — Product Code JER

K791925 is an FDA 510(k) premarket notification submitted by Den-Mat Corp. for the device "DEN-MAT 4-MINUTE DENTURE CLEANER". The FDA issued a decision of Substantially Equivalent on October 26, 1979. The device falls under product code JER (Cleaner, Denture, Mechanical), a Class I device regulated under 21 CFR 872.3530. Den-Mat Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1979
Date Received
September 27, 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 by Den-Mat Corp.

  • K983106 — 1ST IMPRESSION (February 9, 1999)
  • K895731 — DEN-MAT CERINATE PORCELAIN (August 3, 1990)
  • K895269 — DEN-MAT LAMI-QUICK (February 22, 1990)
  • K881918 — LIGHT-CURED ZIONOMER CEMENT (July 15, 1988)
  • K875351 — DEN-MAT PORETCH (PORCELAIN ETCHANT) (March 18, 1988)
  • K872510 — DEN-MAT TENURE (August 24, 1987)
  • K870130 — DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM (February 19, 1987)
  • K864346 — REMBRANDT PORCELAIN TINTING KIT (January 7, 1987)
  • K862449 — DEN-MAT DENTIN LINK (July 22, 1986)
  • K860971 — DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) (March 25, 1986)

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)
  • K791716 — PLAQUE-X DENTURE CLEANSER (October 23, 1979)

FDA data resources