510(k) K781919
- Device
- PLAQUE DETECTION SYSTEM
- Applicant
- CLAIROL, INC.
- 510(k) number
- K781919
- Product code
- NYH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-12-04
- Date received
- 1978-11-13
- Regulation
- 872.1740
- Classification name
- Plaque Disclosing Kit
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3015527463
- 1061124
- 3029780
- 3004111573
- 3011215096
- 1643817
- 8044015
- 3007329020
- 9612300
- 3006542438
- 3009888344
- 3008648418
- 1423537
- 1937310
- 9616088
- 3003941201
- 9615782
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases