Identity
- Trade Name
- AdDent FDA UDI
- Generic Name
- Fibreoptic dental light FDA UDI
- Device Name
- The Microlux 2 Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux 2 applications include an accessory for Proximal Caries detection, and Oral Cancer Screening. FDA UDI
- Model / Reference
- Microlux 2 FDA UDI
- Description
- The Microlux 2 Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux 2 applications include an accessory for Proximal Caries detection, and Oral Cancer Screening. FDA UDI
Identifiers
- Catalog Number
- 110080 FDA UDI
- Primary DI / UDI-DI
- D86911008001 FDA UDI
- 510(k) Number
- K062961 FDA UDI
- FDA Product Code
- NTK FDA UDI
- GMDN Term
- Fibreoptic dental light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1745 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
No
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: Fibreoptic dental light
AdDent by Addent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibreoptic dental light.
- STERLING — BENCO DENTAL SUPPLY CO. · Class I
- AIOBIO — AIOBIO Co., Ltd. · Class I
- AdDent — Addent, Inc. · Class II
Cleared under the same submission
K062961 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
- Addent, Inc.
Sources (1)
- FDA UDI a8c63657-6967-426a-b282-d483375ad7d0 36 fields · synced May 31, 2026