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M4-Right 19mm

FDA UDI

Class I (US FDA UDI)

by Specialty Appliances, Llc

Identity

Trade Name
M4-Right 19mm FDA UDI
Generic Name
Orthodontic rod-based aligner FDA UDI
Model / Reference
900365 FDA UDI

Identifiers

Primary DI / UDI-DI
D8199003650 FDA UDI
FDA Product Code
ECN FDA UDI
GMDN Term
Orthodontic rod-based aligner FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5410 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

No

FDA UDI

Category: Orthodontic rod-based aligner

M4-Right 19mm by Specialty Appliances, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic rod-based aligner.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Specialty Appliances, Llc

Sources (1)

  • FDA UDI aac02350-0eae-44d0-baa6-927345746a0b 32 fields · synced Jun 7, 2026