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Xeno Iii

FDA UDI

Class II (US FDA UDI)

by Dentsply De Trey GmbH

Identity

Trade Name
XENO III FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
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. FDA UDI
Model / Reference
664100 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
664100 FDA UDI
Primary DI / UDI-DI
D0106641001 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 4 Milliliter FDA UDI

Xeno Iii by Dentsply De Trey GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentsply De Trey GmbH

Sources (1)

  • FDA UDI 1c9447e0-4b0a-4e2e-981c-c96e6424f4f3 36 fields · synced May 31, 2026