FDA.reportPublic FDA data

Family Wellness

Primary DI
00032251004278
Brand
Family Wellness
Company
Family Dollar Stores
Model
QKA
Device description
Denture Adhesive, Original
Published
2020-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-SodiumDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00032251906169PackageGS148In Commercial Distribution
00032251004278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00032251906169000322519061690322519061690032251906169
00032251004278000322510042780322510042780032251004278

GMDN Terms#

Term, Definition table
TermDefinition
Carboxymethylcellulose sodium/polymer denture adhesive, zinc-freeAn adhesive compound composed of carboxymethylcellulose sodium and a polymer (e.g., ethylene oxide homopolymer, cationic polyacrylamide polymer, polyvinyl methylether maleic acid salt), that does not contain zinc (i.e., no zinc salts), intended to be used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
117310689
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00032251578113Family Wellness099901086-9142020-01-27
00032251689659FAMILY WELLNESSSKU9037562025-08-01
00032251689666FAMILY WELLNESSSKU9395042025-08-01
00032251689888FAMILY WELLNESSSKU9976692025-08-01
20032251689653FAMILY WELLNESSSKU9397562025-08-01
10032251689663FAMILY WELLNESSSKU9395042025-08-01
10032251689885FAMILY WELLNESSSKU9976692025-08-01
00032251627620Family Wellness9160612020-08-07
00032251627910Family Wellness9995772020-07-09
00032251921612Family Wellness99957786-359FD2023-10-06
00032251921629Family Wellness91606186-3522023-10-06
00032251057489Family Wellness03225105748909088262020-02-28
00032251057502Family Wellness03225105750209088282020-02-28
00032251057847Family Wellness03225105784709032212020-02-28
00032251058158Family Wellness03225105815809108672020-02-28
00032251911798Family Wellness9028072024-07-08
00032251911804Family Wellness9028062024-07-08
00032251911842Family Wellness9398562024-07-08
00032251911859Family Wellness9996002024-07-08
00032251911866Family Wellness9999862024-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06943566100187Y-KelinANHUI GREENLAND BIOTECH CO.,LTDKOT2022-12-06
07506338303460Confident, MDC DentalMDC DENTALKOT2022-09-28
07506338303477Confident, MDC DentalMDC DENTALKOT2022-09-28
07506338303538Confident, MDC DentalMDC DENTALKOT2022-09-28
00032251906169Family WellnessFamily Dollar StoresKOT2020-09-21
00071031517546RexallDOLGENCORP, LLCKOT2020-08-31
00071031518543RexallDOLGENCORP, LLCKOT2020-08-31
00071031938532DG HealthDOLGENCORP, LLCKOT2020-08-31
10071031517543RexallDOLGENCORP, LLCKOT2020-08-31
10071031518540RexallDOLGENCORP, LLCKOT2020-08-31
10071031938539DG HealthDOLGENCORP, LLCKOT2020-08-31
00857331000021DG HealthDOLGENCORP, LLCKOT2020-08-31