FDA.reportPublic FDA data

Confident, MDC Dental

Primary DI
07506338303538
Brand
Confident, MDC Dental
Company
MDC DENTAL
Model
Denture Adhesive Powder
Device description
Confident. Denture Adhesive Powder. Container with 0.7 OZ (20 g).
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
07506338303538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506338303538075063383035387506338303538

GMDN Terms#

Term, Definition table
TermDefinition
Carboxymethylcellulose sodium denture adhesiveAn adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) 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

Contacts#

Phone, Email table
PhoneEmail
3338330333tecnovigilancia@dental.com.mx

Regulatory Flags#

DUNS number
811180298
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07506338322461Nic Tone, MDC Dental Rapid Liquid2025-12-09
07506338301480MDC DentalANTIVET KIT 2023-05-04
07506338322454ROGSON WAX, MDC Dental TRUE EXTRA HARD2025-05-16
07506338322430VIVIDTone 592025-05-12
07506338322447VIVIDTone 652025-05-12
07506338322416ISOTEK, MDC DentalAnterior2025-04-29
07506338322423ISOTEK, MDC DentalPosterior2025-04-29
17506338322413ISOTEK, MDC DentalAnterior2025-04-29
17506338322420ISOTEK, MDC DentalPosterior2025-04-29
07506338322393Polishine, MDC DentalPOLISHINE 100 g2025-01-29
07506338322386New Flex, MDC Dental20 lb2025-01-17
07506338322379VIVIDTone 652025-01-07
07506338322331Nic Tone, MDC Dental Rapid liquid2024-12-18
07506338322355ROGSON WAX, MDC Dental Self-Adhering Plastic Form2024-12-18
07506338322362VIVIDTone 3.52024-12-18
07506338322232NIC TONE, MDC DentalRapid Liquid2024-08-05
07506338321921ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11
07506338321938ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11
07506338321945ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11
07506338321952ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11

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
00032251004278Family WellnessFamily Dollar StoresKOT2020-09-21
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