FDA UDI
In Commercial Distribution
🇺🇸 United States
Confident, MDC Dental
DI: 07506338303477
·
Model: Denture Adhesive Cream
·
MDC DENTAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Confident, MDC Dental
- Primary DI
- 07506338303477
- Version / Model
- Denture Adhesive Cream
- Company Name
- MDC DENTAL
- Labeler DUNS
- 811180298
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 1
- Public Version Date
- 2022-10-06
- Public Version Status
- New
- Public Device Record Key
- 6b41e7e3-4fd2-4433-a9a7-66ce6a5cfdde
Device Description
Confident. Denture Adhesive Cream. Container with 2.6 OZ (75 g)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | Dental | 872.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46125 | Carboxymethylcellulose sodium denture adhesive | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07506338303477 | GS1 |
Customer Contacts
- Phone
- 3338330333
- [email protected]