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One Coat Bond

FDA UDI

Class II (US FDA UDI)

by Coltène/Whaledent AG

Identity

Trade Name
One Coat Bond FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Model / Reference
60011757 FDA UDI

Identifiers

Catalog Number
60011757 FDA UDI
Primary DI / UDI-DI
J006600117570 FDA UDI
510(k) Number
K974906 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

One Coat Bond by Coltène/Whaledent AG — 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

K974906 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coltène/Whaledent AG

Sources (1)

  • FDA UDI 4ac93976-eca0-4394-abb2-94ca8eddd7ec 36 fields · synced May 30, 2026