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Toothette Oral Care

FDA UDI

Class II (US FDA UDI)

by Sage Products Llc

Identity

Trade Name
Toothette Oral Care FDA UDI
Generic Name
Oral care kit, single-use FDA UDI
Device Name
Suction Swab System with Perox-A-Mint Solution FDA UDI
Model / Reference
6552 FDA UDI
Description
Suction Swab System with Perox-A-Mint Solution FDA UDI

Identifiers

Catalog Number
6552 FDA UDI
Primary DI / UDI-DI
00618029821157 FDA UDI
FDA Product Code
JOL FDA UDI
NSB FDA UDI
GMDN Term
Oral care kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6740 FDA UDI
872.6855 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental suction system cannula, single-useBasic manual toothbrushOral care kit, single-useDental tooth-cleaning solution

Toothette Oral Care by Sage Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral care swab.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sage Products Llc

Sources (1)

  • FDA UDI b675344b-b976-4265-b768-e40365f1b522 35 fields · synced May 31, 2026