FDA.report

Aladdin™ TOTAL ETCH Universal Total-Etch Adhesive

Primary DI
D6870099400FG2
Brand
Aladdin™ TOTAL ETCH Universal Total-Etch Adhesive
Company
DENTSPLY INTERNATIONAL INC.
Model
0099400FG
Catalog number
0099400FG
Device description
Aladdin™ Total Etch Adhesive Refill Package (4.5mL)
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KLEAGENT, TOOTH BONDING, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6870099400FG2PackageHIBCC15Not in Commercial Distribution
D6870099400FG1PrimaryHIBCC0

GMDN Terms

TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume4.5Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags

DUNS number
083235549
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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