Home / 510(k) Clearances / K871785

510(k) K871785

DENTURE CLEANSING TABLET by Pennex Products Co., Inc. — Product Code EFT

K871785 is an FDA 510(k) premarket notification submitted by Pennex Products Co., Inc. for the device "DENTURE CLEANSING TABLET". The FDA issued a decision of Substantially Equivalent on September 11, 1987. The device falls under product code EFT (Cleanser, Denture, Over The Counter), a Class I device regulated under 21 CFR 872.3520.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1987
Date Received
May 6, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Denture, Over The Counter
Device Class
Class I
Regulation Number
872.3520
Review Panel
DE
Submission Type

Other clearances for product code EFT

  • K080631 — CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER (May 23, 2008)
  • K051342 — MEDICAL INTERPOROUS (June 2, 2006)
  • K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND (June 16, 2000)
  • K942203 — OTC DENTURE CLEANSER (August 10, 1994)
  • K930337 — PROFAST(R)-DENTURE CLEANSER (September 7, 1993)
  • K914257 — DENTURE PRODUCT X (January 13, 1993)
  • K925259 — CFR MONOGRAPH (January 11, 1993)
  • K902838 — DENTURE DYNAMIC'S DENTURE MAGIC (September 6, 1990)
  • K903686 — ARGILITE 4 GOLD ALLOY FOR PORCELAIN (August 29, 1990)
  • K895345 — ORAD TOOTHBRUSH CLEANER (March 7, 1990)

FDA data resources