FDA UDI
In Commercial Distribution
🇺🇸 United States
DenSureFit Pro
DI: 00860013103255
·
Model: DSFProKit
·
OTC DENTAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DenSureFit Pro
- Primary DI
- 00860013103255
- Version / Model
- DSFProKit
- Company Name
- OTC DENTAL CORPORATION
- Labeler DUNS
- 080416887
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-02
- Public Version
- 1
- Public Version Date
- 2025-09-10
- Public Version Status
- New
- Public Device Record Key
- 39d266ed-0888-4846-b9c5-0a966e2d8805
Device Description
DenSureFit Pro is for professional use only. DSF Pro is a chairside denture reline kit utilizing Vinyl Polysiloxane as the reline material. The contents of the kit contains (1) IFU,(1) 50cc cartridge of VPS, (10) mixing tips compatible with 50cc cartridge, (10) medical swabs, (1)15mL vial of Primer, (5) Snug Up At-Home Care kits for home use. The contents of each Snug Up At-Home Care Kit contains (1) 5mL cartridge of VPS, (3) mixing tips compatible with 5mL cartridge, & (1) At-Home IFU.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31788 | Denture reliner, soft, home-use | A denture relining material such as plastic resin intended to be self-applied at home as a permanent coating or lining on the base or tissue-contact surface of a denture for improved fitting, and which sets to a soft, plastic state. It will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture. 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 | 00860013103255 | GS1 |