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Dentsply Sirona

FDA UDI

Class II (US FDA UDI)

by Dentsply International

Identity

Trade Name
Dentsply Sirona FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Amalgam Bonding Accessory Kit FDA UDI
Model / Reference
634402 FDA UDI
Description
Amalgam Bonding Accessory Kit FDA UDI

Identifiers

Catalog Number
634402 FDA UDI
Primary DI / UDI-DI
D0026344020 FDA UDI
510(k) Number
K964525 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

No

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dentine bonding agent/set

Dentsply Sirona by Dentsply International — 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

K964525 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentsply International

Sources (1)

  • FDA UDI 3c4985b4-9bda-4c50-babe-1f1bcc92bd10 37 fields · synced Jun 8, 2026