FDA.reportPublic FDA data

Xeno® IV One Component Light Cured Self-Etching Dental Adhesive

Primary DI
D0026680050
Brand
Xeno® IV One Component Light Cured Self-Etching Dental Adhesive
Company
DENTSPLY INTERNATIONAL INC.
Model
668005
Catalog number
668005
Device description
Xeno® IV Bottle Sampler
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K041343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041343000XENO NM LIGHT CURED DENTAL ADHESIVEDentsply International2004-06-16KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0026680050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material adhesiveA liquid material specifically made to give adhesion of an impression material to the impression tray. 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. Keep dry.

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
Lot or batch
true
Expiration date on label
true

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D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
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Primary DI, Brand, Company table
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