Identity
- Trade Name
- VIZILITE PRO FDA UDI
- Generic Name
- Oral lesion examination light FDA UDI
- Device Name
- VIZILITE PRO SCREENING SYSTEM FDA UDI
- Model / Reference
- PLS1001 FDA UDI
- Description
- VIZILITE PRO SCREENING SYSTEM FDA UDI
Identifiers
- Catalog Number
- PLS1001 FDA UDI
- Primary DI / UDI-DI
- D813PLS10010 FDA UDI
- 510(k) Number
- K082668 FDA UDI
- FDA Product Code
- NXV FDA UDI
- GMDN Term
- Oral lesion examination light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6350 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oral lesion examination light
Vizilite Pro by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral lesion examination light.
- VELscope — Led Dental, Inc. · Class II
- AdDent — Addent, Inc. · Class II
- OralID — FORWARD SCIENCE TECHNOLOGIES LLC · Class II
- G.o.c.c.l.e.s. light — PIERREL SPA · Class II
- VELscope — Led Dental, Inc. · Class II
- FUSION-DOE Light System — DENTLIGHT INC. · Class II
- VELscope — Led Dental, Inc. · Class II
- ViziLite® — Den-Mat Holdings, LLC · Class I
Cleared under the same submission
K082668 also covers:
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
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 09d8e9e2-e8d7-4646-bb73-5c6710230086 38 fields · synced Jun 9, 2026