Identity
- Trade Name
- AdDent FDA UDI
- Generic Name
- Fibreoptic dental light FDA UDI
- Device Name
- The Microlux Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux applications include an accessory for Proximal Caries detection, and Oral Cancer Screening. FDA UDI
- Model / Reference
- Microlux FDA UDI
- Description
- The Microlux Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux applications include an accessory for Proximal Caries detection, and Oral Cancer Screening. FDA UDI
Identifiers
- Catalog Number
- 620007 FDA UDI
- Primary DI / UDI-DI
- D86962000706 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 62175719-d1dc-4b98-802a-c97be580d7da 36 fields · synced May 30, 2026