Identity
- Trade Name
- Vista-Red Caries 10ml Kit FDA UDI
- Generic Name
- Dental caries detecting stain FDA UDI
- Device Name
- Glycol based solution to facilitate removal of carious dentin. Kit includes 10ml bottle, (6) mixing wells & (24) micro-applicator brushes FDA UDI
- Model / Reference
- 503409 FDA UDI
- Description
- Glycol based solution to facilitate removal of carious dentin. Kit includes 10ml bottle, (6) mixing wells & (24) micro-applicator brushes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10818207020052 FDA UDI
- 510(k) Number
- K955445 FDA UDI
- FDA Product Code
- LFC FDA UDI
- GMDN Term
- Dental caries detecting stain FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1740 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Vista-Red Caries 10ml Kit by Vista Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K955445 also covers:
- Vista-Green Caries Indicator Refill Pack — Vista Dental
- Vista-Green Caries Indicator Standard Kit — Vista Dental
- Vista-Green Caries Indicator Value Pack — Vista Dental
- Vista-Green Unit Dose — Vista Dental
- Vista-Red Caries Indicator Standard Pack — Vista Dental
- Vista-Red Caries Refill Pack — Vista Dental
- Vista-Red Caries Unit Dose — Vista Dental
- Vista-Red Caries Value Pack — Vista Dental
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vista Dental
Sources (1)
- FDA UDI db52ccd2-9785-4090-8ec2-552bf38c3870 35 fields · synced May 30, 2026