FDA.reportPublic FDA data

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

Primary DI
D0026680021
Brand
Xeno® IV One Component Light Cured Self-Etching Dental Adhesive
Company
DENTSPLY INTERNATIONAL INC.
Model
668002
Catalog number
668002
Device description
Xeno® IV One Component Self-Etching Dental Adhesive Unit Dose Package
Published
2016-09-21
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
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
D0026680021PrimaryHIBCC0
D0026680020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dentine adhesiveA material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
083235549
Device count
100
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
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