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Select SE-Bond LC

FDA UDI

Class II (US FDA UDI)

by Zendo Direct AG

Identity

Trade Name
Select SE-Bond LC FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
One component self-etching light cure adhesive - One-component; 5ml Bottle FDA UDI
Model / Reference
SEL-ETCH-LC-5ml FDA UDI
Description
One component self-etching light cure adhesive - One-component; 5ml Bottle FDA UDI

Identifiers

Catalog Number
SEL-ETCH-LC-5ml FDA UDI
Primary DI / UDI-DI
07540208000165 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
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

No

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dentine bonding agent/set

Select SE-Bond LC by Zendo Direct AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zendo Direct AG

Sources (1)

  • FDA UDI 7de7d699-55e7-4d86-ab72-3afb85e94fb5 35 fields · synced May 30, 2026