← Back to catalogue

A2

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name
A2 FDA UDI
Generic Name
Orthodontic aligner auxiliary attachment kit FDA UDI
Device Name
The aligner attachment kit is intended for use in the creation of molds for thermoplastic alligners. The Oval Attachment Form can be used for the retention of the thermoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown. The Rectangle Attachment Form can be used for individual tooth movement and for extrusion of teeth. The Assure Bonding Resin included will bond to all intraoral surfaces without additional primers. L.C.R. Light Cure Paste cures smooth as glass for patient comfort. It has a very high Barcol Hardness for long term durability. FDA UDI
Model / Reference
A2 FDA UDI
Description
The aligner attachment kit is intended for use in the creation of molds for thermoplastic alligners. The Oval Attachment Form can be used for the retention of the thermoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown. The Rectangle Attachment Form can be used for individual tooth movement and for extrusion of teeth. The Assure Bonding Resin included will bond to all intraoral surfaces without additional primers. L.C.R. Light Cure Paste cures smooth as glass for patient comfort. It has a very high Barcol Hardness for long term durability. FDA UDI

Identifiers

Catalog Number
A2 FDA UDI
Primary DI / UDI-DI
D798A20 FDA UDI
FDA Product Code
KLE FDA UDI
EBI FDA UDI
KXR FDA UDI
GMDN Term
Orthodontic aligner auxiliary attachment kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 FDA UDI
872.3760 FDA UDI
872.3140 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

A2 by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
Reliance Orthodontic Products, Inc.

Sources (1)

  • FDA UDI 9a1f6d38-02c2-4840-b76a-ae3356b3b5b7 37 fields · synced Jun 8, 2026