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Smartlite Pro Endo Activator Activator

FDA UDI

Class I (US FDA UDI)

by Dentsply International

Identity

Trade Name
Smartlite Pro Endo Activator Activator FDA UDI
Generic Name
Root canal ultrasonic irrigation handpiece tip FDA UDI
Model / Reference
644435 FDA UDI

Identifiers

Catalog Number
644435 FDA UDI
Primary DI / UDI-DI
D0016444351 FDA UDI
FDA Product Code
EKQ FDA UDI
GMDN Term
Root canal ultrasonic irrigation handpiece tip FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Root canal ultrasonic irrigation handpiece tip

Smartlite Pro Endo Activator Activator by Dentsply International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Root canal ultrasonic irrigation handpiece tip.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentsply International

Sources (1)

  • FDA UDI 5128c27d-ba97-4891-b42a-44f58abd2e66 33 fields · synced May 30, 2026