Identity
- Trade Name
- ProxiCure Ball Lenses 2pk EUDAMEDVALO FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- Valo EUDAMEDProxiCure Ball Lenses 2pk FDA UDI
- Model / Reference
- 5936 EUDAMED5936- FDA UDI
- Description
- ProxiCure Ball Lenses 2pk FDA UDI
Identifiers
- Catalog Number
- 5936- FDA UDI
- Primary DI / UDI-DI
- 00883205102997 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF086BF EUDAMED
- 510(k) Number
- K210550 FDA UDI
- FDA Product Code
- EBZ 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 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
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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
K210550 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.
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 1e8b5b88-e7e6-4698-9c3a-63af8ba0f245 36 fields · synced Jun 18, 2026
- EUDAMED bb66aac9-5320-4694-ac7c-ee3411413981 61 fields · synced Jun 18, 2026