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StarDental

FDA UDI

Class I (US FDA UDI)

by Dentalez, Inc.

Identity

Trade Name
StarDental FDA UDI
Generic Name
Dental surgical power tool motorized handpiece/set, electric FDA UDI
Device Name
STAR E900 1:5 AC FO, HANDPIECE FDA UDI
Model / Reference
266342 FDA UDI
Description
STAR E900 1:5 AC FO, HANDPIECE FDA UDI

Identifiers

Catalog Number
266342 FDA UDI
Primary DI / UDI-DI
D7022663420 FDA UDI
510(k) Number
K240183 FDA UDI
FDA Product Code
EGS 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

StarDental by Dentalez, Inc. — 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

K240183 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentalez, Inc.

Sources (1)

  • FDA UDI bcc6f840-cb92-4a4a-865a-ecbc9a64ad7b 36 fields · synced Jun 6, 2026