Icon®

Primary DI
EDMG2204030
Brand
Icon®
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
220403
Catalog number
220403
Device description
Infiltration Concept. Resin Infiltration - Smooth Surface. The effective approach to treating withe spots. Content: 7 treatment units (each contains 1 syringe Icon-Etch @ 0.45 ml, 1 syringe Icon-Dry @0.45 ml, 1 syringe Icon-Infiltrant @ 0.45 ml), accessories.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBCSealant, Pit And Fissure, And Conditioner

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100062000INFILTRATION KITDmg USA, Inc.2010-03-26EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG2204031PackageHIBCC7In Commercial Distribution
EDMG2204030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental unfilled resin sealant/coatingA non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00After use, dispose of the product in household waste.
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
201-894-5505eanagnostos@dmg-america.com

Regulatory Flags#

DUNS number
320744915
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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EDMG1104000Luxatemp® Automix Plus1104001104002016-09-21
EDMG1104010Luxatemp® Automix Plus1104011104012016-09-21
EDMG1104020Luxatemp® Automix Plus1104021104022016-09-21
EDMG1104030Luxatemp® Automix Plus1104031104032016-09-21
EDMG1104040Luxatemp® Automix Plus1104041104042016-09-21
EDMG1104060Luxatemp® Automix Plus1104061104062016-09-21
EDMG1105850Luxatemp® Fluorescence1105851105852016-09-21
EDMG1105860Luxatemp® Fluorescence1105861105862016-09-21
EDMG1105870Luxatemp® Fluorescence1105871105872016-09-21
EDMG1105880Luxatemp® Fluorescence1105881105882016-09-21
EDMG1105890Luxatemp® Fluorescence1105891105892016-09-21
EDMG1107100Luxatemp® Fluorescence1107101107102016-09-21
EDMG1107190Luxatemp® Fluorescence1107191107192016-09-23
EDMG1107220Luxatemp® Fluorescence1107221107222016-09-23
EDMG1107230Luxatemp® Fluorescence1107231107232016-09-23
EDMG2123841LuxaBond - Total Etch2123842123842016-09-23
EDMG2133201TECO2133202133202016-09-22
EDMG2130801Vitique2130802130802016-09-22

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