Product Code: KOQ FDA class 1 21 CFR 872.3410

Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)

Dental

This device is a denture adhesive containing carboxymethylcellulose sodium at a concentration of 40 to 100 percent, intended to secure removable dentures to the gums. It is classified as FDA Class 1, the lowest risk category, subject to general controls such as labeling and good manufacturing practices. The product code is KOQ, regulated under 21 CFR 872.3410 within the Dental specialty. No special flags apply to this device.

510(k)s
4
FEI Numbers
11
Registration Numbers
11
Unique Applicants
3
Years Active
7

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Basic Information

Product Code
KOQ
Device Class
FDA class 1
Regulation Number
872.3410
Medical Specialty
Dental
Review Panel
DE
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number Device Name
K901882 URESIL ENDOSCOPIC LASER OVERTUBE
K900401 NAS&P GRASPING FORCEPS & ASSOC. DEVICES
K896821 OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE
K831265 DENTOLOCK DENTURE ADHESIVE CREAM

FEI Numbers

This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.