Atomo

FDA UDI

Class I (US FDA UDI)

by Atomo Dental, Inc.

Identity

Trade Name: ATOMO FDA UDI
Generic Name: Saliva absorbent FDA UDI
Device Name: ATOMO Non-woven sponge 2"x2" FDA UDI
Model / Reference: AA0030 FDA UDI
Description: ATOMO Non-woven sponge 2"x2" FDA UDI

Identifiers

Primary DI / UDI-DI: D883AA00301 FDA UDI
FDA Product Code: NAB FDA UDI
GMDN Term: Saliva absorbent FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4014 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Saliva absorbent

Atomo by Atomo Dental, 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: Atomo Dental, Inc.

Sources (1)

FDA UDI 63b19402-4b86-4ef9-a89a-2e1e3143d4fc 33 fields · synced May 30, 2026