Identity
- Trade Name
- Vista-Red Caries Value Pack FDA UDI
- Generic Name
- Dental caries detecting stain FDA UDI
- Device Name
- Glycol based solution to facilitate removal of carious dentin. Value pack includes (20) 1.2ml prefilled syringes FDA UDI
- Model / Reference
- 503450 FDA UDI
- Description
- Glycol based solution to facilitate removal of carious dentin. Value pack includes (20) 1.2ml prefilled syringes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10818207020038 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
- 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
No
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
Category: Dental caries detecting stain
Vista-Red Caries Value Pack by Vista Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Expose — CENTRIX, INC. · Class II
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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
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
- Vista Dental
Sources (1)
- FDA UDI 0c018070-836c-4cba-92af-f4ad0d0cfb62 34 fields · synced May 30, 2026