FDA.reportPublic FDA data

Coltolux Comfort

Primary DI
07630392901413
Brand
Coltolux Comfort
Company
Dent4You AG
Model
60034391
Device description
SPARE BATTERY, COLTOLUX COMFORT
Published
2023-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EBZActivator, Ultraviolet, For Polymerization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBZActivator, Ultraviolet, For PolymerizationDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223142000Coltolux Comfort LED Curing LightDent4you AG2022-12-22EBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630392901413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630392901413076303929014137630392901413

GMDN Terms#

Term, Definition table
TermDefinition
LED dental light, battery-poweredA battery-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 light-emitting diode (LED), situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit, containing rechargeable batteries, via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480152811
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640397422042StatClean Ultrasonic CleanerSC-P4862SC-P48622026-03-11
07640397422189HYDRIM 112W G4+ Instrument WasherG4-W10001G4-W100012026-02-11
17640397422339HIP Cleaning SolutionCS-HIPTCS-HIPT2026-02-11
07640397422349HYDRIM 112W G4+ Instrument WasherG4-W10001-LG4-W10001-L2026-02-11
07640397422356HYDRIM 112W G4+ Instrument WasherG4-W10001-RG4-W10001-R2026-02-11
07630243600595BRILLIANT Crios60019985600199852026-02-10
07630243600601BRILLIANT Crios60019986600199862026-02-10
07630243600618BRILLIANT Crios60019987600199872026-02-10
07630243600625BRILLIANT Crios60019988600199882026-02-10
07630243600632BRILLIANT Crios60019989600199892026-02-10
07630243600649BRILLIANT Crios60019990600199902026-02-10
07630243600656BRILLIANT Crios60019991600199912026-02-10
07630243600663BRILLIANT Crios60019992600199922026-02-10
07630243600670BRILLIANT Crios60019993600199932026-02-10
07630243600687BRILLIANT Crios60019994600199942026-02-10
07630243600694BRILLIANT Crios60019995600199952026-02-10
07630243600700BRILLIANT Crios60019996600199962026-02-10
07630243600717BRILLIANT Crios60019997600199972026-02-10
07630243600724BRILLIANT Crios60019998600199982026-02-10
07630243600731BRILLIANT Crios60019999600199992026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126506191Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEBZ2026-03-05
00810126506207Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEBZ2026-03-05
J014660164550Starlight proKulzer GmbHEBZ2026-01-28
J014660573650Starlight proKulzer GmbHEBZ2026-01-28
J014660968300Starlight proKulzer GmbHEBZ2026-01-28
J014660969290Starlight proKulzer GmbHEBZ2026-01-28
J014660971690Starlight proKulzer GmbHEBZ2026-01-28
J014660971700Starlight proKulzer GmbHEBZ2026-01-28
00883205044372Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044389Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044396Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044402Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044419Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044426Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
D0029444001SmartLite® Pro Modular LED Curing LightDENTSPLY INTERNATIONAL INC.EBZ2025-09-09
00883205035561Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-21
00883205041906VALOULTRADENT PRODUCTS, INC.EBZ2025-08-21
00883205032997VALOULTRADENT PRODUCTS, INC.EBZ2025-08-20
00883205042873Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042880Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042897Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042903Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042910Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042927Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042934Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043269Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043276Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043283Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043290Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043306Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14