XENO III 664100

GUDID D0106641001

XENO III INTRO KIT is a 2 component single step self-etching dental adhesive. Both components (D010K3027080 and D010K3027090) need to be mixed before use. With its supporting accessories (Applicator Tips and Clixdish) it can be classified as a convenience kit.

Dentsply De Trey GmbH

Dentine bonding agent/set

Primary Device ID	D0106641001
NIH Device Record Key	1c9447e0-4b0a-4e2e-981c-c96e6424f4f3
Commercial Distribution Discontinuation	2021-10-13
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	XENO III
Version Model Number	664100
Catalog Number	664100
Company DUNS	315471722
Company Name	Dentsply De Trey GmbH
Device Count	1
DM Exempt	true
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0
Total Volume	4 Milliliter
Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0106641001 [Primary]

FDA Product Code

KLE	AGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2021-10-14
Device Publish Date	2016-09-20

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