AccessGUDID - DEVICE: AdDent (D86911008001)

GUDID

Device Identifier (DI) Information

Brand Name: AdDent
Version or Model: Microlux 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110080
Company Name: ADDENT, INC.

Primary DI Number: D86911008001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 099490679 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTK	Caries Detector, Laser Light, Transmission

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062961	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8c63657-6967-426a-b282-d483375ad7d0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 01, 2017