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510(k) K930337

PROFAST(R)-DENTURE CLEANSER by Fittydent-Altwirth & Schmitt GmbH — Product Code EFT

K930337 is an FDA 510(k) premarket notification submitted by Fittydent-Altwirth & Schmitt GmbH for the device "PROFAST(R)-DENTURE CLEANSER". The FDA issued a decision of Substantially Equivalent on September 7, 1993. The device falls under product code EFT (Cleanser, Denture, Over The Counter), a Class I device regulated under 21 CFR 872.3520. Fittydent-Altwirth & Schmitt GmbH has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1993
Date Received
January 22, 1993
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 by Fittydent-Altwirth & Schmitt GmbH

  • K930335 — PROFAST - DENTURE ADHESIVE FOR LOWER JAWS (February 1, 1994)
  • K930336 — PROFAST(R)-DENTURE ADHESIVE CREAM (August 24, 1993)

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)
  • 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)
  • K890043 — DENTCLEAN CONCENTRATED DENTURE CLEANSER (June 7, 1989)

FDA data resources