← Back to catalogue

MiniScope-Right 27mm

FDA UDI

Class I (US FDA UDI)

by Specialty Appliances, Llc

Identity

Trade Name
MiniScope-Right 27mm FDA UDI
Generic Name
Orthodontic rod-based aligner FDA UDI
Model / Reference
900335 FDA UDI

Identifiers

Primary DI / UDI-DI
D8199003350 FDA UDI
FDA Product Code
DYJ 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

MiniScope-Right 27mm 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Specialty Appliances, Llc

Sources (1)

  • FDA UDI e42b0a47-741b-4fc3-a75e-9ac14f346dac 32 fields · synced Jun 8, 2026