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Frankel

FDA UDI

Class I (US FDA UDI)

by Allesee Aoa-Pro

Identity

Trade Name
Frankel FDA UDI
Generic Name
Orthodontic palate expander/teeth aligner, self-removable FDA UDI
Device Name
Frankel FDA UDI
Model / Reference
3000-0013 FDA UDI
Description
Frankel FDA UDI

Identifiers

Primary DI / UDI-DI
00889989038460 FDA UDI
FDA Product Code
KMY FDA UDI
GMDN Term
Orthodontic palate expander/teeth aligner, self-removable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5525 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic palate expander/teeth aligner, self-removable

Frankel by Allesee Aoa-Pro — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic palate expander/teeth aligner, self-removable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Allesee Aoa-Pro

Sources (1)

  • FDA UDI b05fd551-8992-4693-800f-a97b149d1841 34 fields · synced Jun 8, 2026