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Z-Evo

FDA UDI

Class I (US FDA UDI)

by Nusmile, Ltd

Identity

Trade Name
Z-Evo FDA UDI
Generic Name
Dental surgical power tool motorized handpiece/set, electric FDA UDI
Device Name
Endodontic motor with integrated apex locator with continuous and reciprocating rotation. FDA UDI
Model / Reference
6080241 FDA UDI
Description
Endodontic motor with integrated apex locator with continuous and reciprocating rotation. FDA UDI

Identifiers

Primary DI / UDI-DI
00810092938637 FDA UDI
510(k) Number
K201993 FDA UDI
FDA Product Code
EKX FDA UDI
LQY FDA UDI
GMDN Term
Dental surgical power tool motorized handpiece/set, electric 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental surgical power tool motorized handpiece/set, electric

Z-Evo by Nusmile, Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental surgical power tool motorized handpiece/set, electric.

Cleared under the same submission

K201993 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nusmile, Ltd

Sources (1)

  • FDA UDI a3a023fe-c420-43b8-a4fa-3a8774a81f2b 35 fields · synced Jun 1, 2026