FDA.reportPublic FDA data

AdDent

Primary DI
D86911008001
Brand
AdDent
Company
ADDENT, INC.
Model
Microlux 2
Catalog number
110080
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.
Published
2017-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NTKCaries Detector, Laser Light, Transmission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTKCaries Detector, Laser Light, TransmissionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062961000MICROLUX TRANSILLUMINATORAddent, Inc.2007-02-08NTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D86911008001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic dental lightA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2037780200dpinto@addent.com

Regulatory Flags#

DUNS number
099490679
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8691300001AdDentCompex HD1300002026-04-22
D8691120010AdDentOraBlu1120012017-06-01
D86962000706AdDentMicrolux6200072017-06-01
D8691100000AdDentCalset1100002017-06-01
D86911009002AdDentBio/Screen1100902017-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E27668082030Primescan 2SIRONA Dental Systems GmbHNTK2025-11-21
E27668082450Primescan 2SIRONA Dental Systems GmbHNTK2025-10-23
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNTK2025-09-16
E27668558402Primescan 2SIRONA Dental Systems GmbHNTK2025-08-20
E27668020400Primescan 2SIRONA Dental Systems GmbHNTK2025-05-16
00816063023067iTero Lumina ProAlign Technology, Inc.NTK2025-03-06
04262352350035DI ScanZetta25 AGNTK2025-02-21
10194665007928A-dec A-DEC, INC.NTK2025-02-11
EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-12-03
00816063022213iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
00816063022237iTero Lumina Pro MobileAlign Technology, Inc.NTK2024-11-19
00816063022268iTero Lumina Pro intraoral scanning unitAlign Technology, Inc.NTK2024-11-19
00816063022329iTero Lumina Pro DOAAlign Technology, Inc.NTK2024-11-19
00816063022428iTero Lumina Pro UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022442iTero Lumina Pro Mobile UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022466iTero Lumina Pro UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022589iTero Lumina Pro Wand Barrier SleevesAlign Technology, Inc.NTK2024-11-19
00816063022657iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
00816063022664iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
EKAV101112130DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-02-01
EKAV101315000DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-02-01
00858809006224Planmeca Emerald SD4D TECHNOLOGIES, LLCNTK2022-07-06
EKAV100270000DIAGNOdent pen 2190KaVo Dental GmbHNTK2022-04-15
E247J27131CamX Proxi Interchangeable HeadDÜRR DENTAL SENTK2022-03-04
00816063020691iTero Element 5D Plus cart configuration Align Technology, Inc.NTK2021-06-04
00816063020707iTero Element 5D Plus US cart configurationAlign Technology, Inc.NTK2021-06-04
00816063020721iTero Element 5D Plus upgrade cart configurationAlign Technology, Inc.NTK2021-06-04
00816063020745iTero Element 5D Plus mobile configurationAlign Technology, Inc.NTK2021-06-04
00816063020752iTero Element 5D Plus US mobile configurationAlign Technology, Inc.NTK2021-06-04
00816063020776iTero Element 5D Plus upgrade mobile configurationAlign Technology, Inc.NTK2021-06-04