Aladdin™ Total Self-Cure Activator

Primary DI
D6870099405FG2
Brand
Aladdin™ Total Self-Cure Activator
Company
DENTSPLY INTERNATIONAL INC.
Model
0099405FG
Catalog number
0099405FG
Device description
Aladdin™ Total Self-Cure Activator (1 Bottle x 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLEAGENT, TOOTH BONDING, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964525000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964525000PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATORDentsply Intl.1997-01-22KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6870099405FG2PackageHIBCC15Not in Commercial Distribution
D6870099405FG1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental restorative material curing activatorA dental, dual-cured, resin-based material intended to be mixed with a light-cured bonding agent prior to its application, to promote curing (bonding) between the bonding agent and a self- or dual-cured restorative material (e.g., cement, composite resin). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume4.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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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