Home / 510(k) Clearances / K772087

510(k) K772087

ULTRASONIC DENTURE CLEANER by Clairol, Inc. — Product Code EFT

K772087 is an FDA 510(k) premarket notification submitted by Clairol, Inc. for the device "ULTRASONIC DENTURE CLEANER". The FDA issued a decision of Substantially Equivalent on November 14, 1977. The device falls under product code EFT (Cleanser, Denture, Over The Counter), a Class I device regulated under 21 CFR 872.3520. Clairol, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1977
Date Received
November 3, 1977
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 Clairol, Inc.

  • K852604 — MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK (August 12, 1985)
  • K781919 — PLAQUE DETECTION SYSTEM (December 4, 1978)
  • K770368 — ORAL IRRIGATOR (March 1, 1977)

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