FDA UDI
In Commercial Distribution
🇺🇸 United States
AdDent
DI: D86962000706
·
Model: Microlux
·
ADDENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AdDent
- Primary DI
- D86962000706
- Version / Model
- Microlux
- Catalog Number
- 620007
- Company Name
- ADDENT, INC.
- Labeler DUNS
- 099490679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 62175719-d1dc-4b98-802a-c97be580d7da
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NTK | Caries Detector, Laser Light, Transmission | Dental | 872.1745 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12352 | Fibreoptic dental light | A mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a fibreoptic cable to illuminate the site of a dental examination or procedure. The illumination is produced by the light source of the device, a dedicated light bulb, and is transmitted via the fibreoptic cable which is attached to a dental handpiece held, or a headband worn, by dental staff. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D86962000706 | HIBCC |
Customer Contacts
- Phone
- 2037780200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062961 | 000 |