← Back to catalogue

Vitique Silane

FDA UDI

Class II (US FDA UDI)

by DMG Chemisch-Pharmazeutische Fabrik GmbH

Identity

Trade Name
Vitique Silane FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Coupling agent for conditioning of ceramics and composites. Content: 1 bottle @ 3 ml Adhesive, 1 bottle @3 ml Activator, Accessories. FDA UDI
Model / Reference
213118 FDA UDI
Description
Coupling agent for conditioning of ceramics and composites. Content: 1 bottle @ 3 ml Adhesive, 1 bottle @3 ml Activator, Accessories. FDA UDI

Identifiers

Catalog Number
213118 FDA UDI
Primary DI / UDI-DI
EDMG2131181 FDA UDI
510(k) Number
K023649 FDA UDI
K063444 FDA UDI
FDA Product Code
KLE FDA UDI
EMA FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 FDA UDI
872.3275 FDA UDI
Commercial Distribution
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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental composite resinDentine bonding agent/set

Vitique Silane by DMG Chemisch-Pharmazeutische Fabrik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Cleared under the same submission

K023649 also covers:

K063444 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
DMG Chemisch-Pharmazeutische Fabrik GmbH

Sources (1)

  • FDA UDI d0280341-c1ac-4bb5-816f-fadff1c2f12c 37 fields · synced Jun 1, 2026