FDA.reportPublic FDA data

DG Health

Primary DI
00071031938532
Brand
DG Health
Company
DOLGENCORP, LLC
Model
QWC
Device description
Denture Adhesive, Original
Published
2020-08-31
Public version status
Update
Distribution status
Not 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
10071031938539PackageGS148Not in Commercial Distribution
00071031938532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007103193853910071031938539
00071031938532000710319385320710319385320071031938532

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
068331990
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017276224771Rexall0172762247712020-09-07
00834533001414DG HealthBDGGC362026-03-23
00834533001445DG HealthBDGGS182026-03-23
10834533001411DG HealthBDGGC362026-03-23
10834533001442DG HealthBDGGS182026-03-23
00751774000030DG Health20002256N/A2026-02-20
10751774000037DG Health20002256N/A2026-02-20
00751774242461Rexall One Step Pregnancy Test2020-07-10
00751774250473Rexall One Step Pregnancy Test2020-07-10
00197344018737RexallDG4335DG43352025-10-02
00751774260472Dollar GeneralOne Step Pregnancy Test2025-05-09
00751774262469DG HealthOne Step Pregnancy TestN/A2025-05-09
00845717090001Rexall77-35277-3522016-09-24
00845717773591Rexall77-35977-3592016-09-24
10751774260479Dollar GeneralOne Step Pregnancy Test2025-05-09
10751774262466DG HealthOne Step Pregnancy TestN/A2025-05-09
00646011887409Rexall Sterile Saline Wound Wash88-50740-200-002024-10-04
00197344110059RexallDG4345DG43452024-08-08
10197344110056RexallDG4345DG43452024-08-08
00751774250787DG healthOne Step Pregnancy TestN/A2023-10-27

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
00032251906169Family WellnessFamily Dollar StoresKOT2020-09-21
00071031517546RexallDOLGENCORP, LLCKOT2020-08-31
00071031518543RexallDOLGENCORP, LLCKOT2020-08-31
10071031517543RexallDOLGENCORP, LLCKOT2020-08-31
10071031518540RexallDOLGENCORP, LLCKOT2020-08-31
10071031938539DG HealthDOLGENCORP, LLCKOT2020-08-31
00857331000021DG HealthDOLGENCORP, LLCKOT2020-08-31