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CanalPro

FDA UDI

Class I (US FDA UDI)

by Coltene/Whaledent Inc.

Identity

Trade Name
CanalPro FDA UDI
Generic Name
Dental power tool system handpiece, battery-powered FDA UDI
Device Name
CL2 Charging Base FDA UDI
Model / Reference
60018733 FDA UDI
Description
CL2 Charging Base FDA UDI

Identifiers

Primary DI / UDI-DI
D661600187330 FDA UDI
510(k) Number
K123582 FDA UDI
FDA Product Code
EKX FDA UDI
GMDN Term
Dental power tool system handpiece, battery-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental power tool system handpiece, battery-powered

CanalPro by Coltene/Whaledent Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental power tool system handpiece, battery-powered.

Cleared under the same submission

K123582 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coltene/Whaledent Inc.

Sources (1)

  • FDA UDI a28d1d76-f0fb-40e2-b0b8-7879e8caa3fb 35 fields · synced Jun 9, 2026