FDA.reportPublic FDA data

Family Wellness

Primary DI
00032251906169
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
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117310689
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00032251004278Family 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