Identity
- Trade Name
- VALO X ProxiCure Ball Lens EUDAMEDVALO FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- Valo EUDAMEDVALO X ProxiCure Ball Lens 2pk FDA UDI
- Model / Reference
- 5889 EUDAMEDFDA UDI
- Description
- VALO X ProxiCure Ball Lens 2pk FDA UDI
Identifiers
- Catalog Number
- 5889 FDA UDI
- Primary DI / UDI-DI
- 00883205034168 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF370BF EUDAMED
- 510(k) Number
- K220471 FDA UDI
- FDA Product Code
- EBZ FDA UDIEAQ FDA UDIPEQ FDA UDI
- EMDN Code
- Z12119003 COLD LIGHT DENTAL EQUIPMENT EUDAMED
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6070 FDA UDI872.6350 FDA UDI880.6320 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental/surgical polymerization lamp
Valo by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental/surgical polymerization lamp.
- LEDEX — Dentmate Technology Co. , Ltd. · Class II
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- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- Coltolux — Coltene/Whaledent Inc. · Class II
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- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (2)
- FDA UDI 6e9678c3-93ee-42ba-80fd-425c02d20033 36 fields · synced Jul 28, 2026
- EUDAMED 68e35cee-0ece-4504-9dd5-eea7140f5306 61 fields · synced Jul 28, 2026