Aseptico

FDA UDI

Class I (US FDA UDI)

by Aseptico, Inc.

Identity

Trade Name: Aseptico FDA UDI
Generic Name: Ultrasonic dental scaling/debridement system FDA UDI
Device Name: Transport III Portable electrical dental delivery system with built in Piezo ultrasonic scaler and military spec case FDA UDI
Model / Reference: AEU-525CF FDA UDI
Description: Transport III Portable electrical dental delivery system with built in Piezo ultrasonic scaler and military spec case FDA UDI

Identifiers

Catalog Number: AEU-525CF FDA UDI
Primary DI / UDI-DI: 10817417020029 FDA UDI
510(k) Number: K130693 FDA UDI
FDA Product Code: EIA FDA UDI
EKX FDA UDI
ELC FDA UDI
GMDN Term: Ultrasonic dental scaling/debridement system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6640 FDA UDI
872.4200 FDA UDI
872.4850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 57 Pound FDA UDI

Category: Ultrasonic dental scaling/debridement system

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Aseptico, Inc.

Sources (1)

FDA UDI f976d28d-0f7c-4a69-9ae1-00ccf6dff07c 39 fields · synced May 30, 2026