510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K781919Substantially Equivalent

Plaque Detection System

Clairol, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781919 is the FDA 510(k) clearance record for PLAQUE DETECTION SYSTEM, a class II device, cleared for Clairol, Inc. on under FDA product code NYH (Plaque Disclosing Kit). FDA's definition for product code NYH reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the...". FDA records list 4 510(k) clearances for Clairol, Inc., from to . As of , FDA records show no recalls naming K781919.

Clearance record

Decision date
Received
(21 days to decision)
Product code
NYH Plaque Disclosing Kit
Regulation
21 CFR 872.1740
Device class
Class II
Review panel
Dental
Applicant
Clairol, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code NYH

Trailing 12 months

FDA records hold no clearances under product code NYH in the trailing twelve months.

FDA records show no clearances under product code NYH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NYH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260