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OrthoFlex

FDA UDI

Class II (US FDA UDI)

by Ortho Technology, Inc.

Identity

Trade Name
OrthoFlex FDA UDI
Generic Name
Orthodontic bracket, plastic, single-use FDA UDI
Device Name
OrthoFlex Clear Comp M 022 UL2 Rx +10° Tor. +8° Ang.(10PK) FDA UDI
Model / Reference
COM-812-C FDA UDI
Description
OrthoFlex Clear Comp M 022 UL2 Rx +10° Tor. +8° Ang.(10PK) FDA UDI

Identifiers

Primary DI / UDI-DI
00190730002235 FDA UDI
510(k) Number
K973776 FDA UDI
FDA Product Code
DYW FDA UDI
GMDN Term
Orthodontic bracket, plastic, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5470 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

OrthoFlex by Ortho Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K973776 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Technology, Inc.

Sources (1)

  • FDA UDI d75fd988-2373-494d-8130-a70520f54b1d 35 fields · synced May 31, 2026