Identity
- Trade Name
- Valo X FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- VALO X Pink FDA UDI
- Model / Reference
- 6497 FDA UDI
- Description
- VALO X Pink FDA UDI
Identifiers
- Catalog Number
- 6497 FDA UDI
- Primary DI / UDI-DI
- 00883205042880 FDA UDI
- 510(k) Number
- K220471 FDA UDI
- FDA Product Code
- EBZ FDA UDIEAQ FDA UDIPEQ FDA UDI
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6070 FDA UDI872.6350 FDA UDI880.6320 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental/surgical polymerization lamp
Valo X by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental/surgical polymerization lamp.
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- Coltolux — Coltene/Whaledent Inc. · Class II
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Cleared under the same submission
K220471 also covers:
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
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
- Ultradent Products, Inc.
Sources (1)
- FDA UDI 7e88ae0e-212a-4d3c-8af4-f7db36d9a347 36 fields · synced May 31, 2026