FDA.report

Coltolux Comfort

Primary DI
17630392901434
Brand
Coltolux Comfort
Company
Dent4You AG
Model
60034393
Device description
BARRIER SLEEVES, 1000PK
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
true

Related Records

Product Codes

CodeName
EBZActivator, Ultraviolet, For Polymerization

Product Code Classifications

CodeDeviceSpecialtyClass
EBZActivator, Ultraviolet, For PolymerizationDental2

Premarket Submissions

SubmissionSupplement
K223142000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223142000Coltolux Comfort LED Curing LightDent4you AG2022-12-22EBZ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630392901437PrimaryGS10
17630392901434Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630392901437076303929014377630392901437
1763039290143417630392901434

GMDN Terms

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

Regulatory Flags

DUNS number
480152811
Device count
1000
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

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