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Aseptico

FDA UDI

Class I (US FDA UDI)

by Aseptico, Inc.

Identity

Trade Name
Aseptico FDA UDI
Generic Name
Dental surgical power tool motor, electric FDA UDI
Device Name
Electronic Endodontic System FDA UDI
Model / Reference
AEU-25 FDA UDI
Description
Electronic Endodontic System FDA UDI

Identifiers

Primary DI / UDI-DI
10817417020821 FDA UDI
FDA Product Code
EKX FDA UDI
GMDN Term
Dental surgical power tool motor, 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

No

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 motor, electric

Aseptico by Aseptico, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental surgical power tool motor, electric.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aseptico, Inc.

Sources (1)

  • FDA UDI 667b75b6-0c0c-4a90-8dca-ca59c43a91c3 34 fields · synced Jun 8, 2026