Identity
- Trade Name
- DenSureFit Pro FDA UDI
- Generic Name
- Denture reliner, soft, home-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- DSFProKit FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013103255 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture reliner, soft, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Denture reliner, soft, home-use
DenSureFit Pro by Otc Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Otc Dental
Sources (1)
- FDA UDI 39d266ed-0888-4846-b9c5-0a966e2d8805 33 fields · synced Jun 8, 2026