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Excel

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name
Excel FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Excel Herbst Kit is intended for use as an orthodontic bonding adhesive for large acrylic appliances. This Kit contains 1 X 12g Excel Regular Adhesive paste in Jar Part A with fluoride , 1 X 12g Excel Regular Adhesive paste in jar Part B, 1 X 7g Bonding resin A , 1 X 7g Bonding resin B , 1 X 9g liquid Etchant and 1 X plastic Conditioner . Contains Fluoride. FDA UDI
Model / Reference
EHJF FDA UDI
Description
Excel Herbst Kit is intended for use as an orthodontic bonding adhesive for large acrylic appliances. This Kit contains 1 X 12g Excel Regular Adhesive paste in Jar Part A with fluoride , 1 X 12g Excel Regular Adhesive paste in jar Part B, 1 X 7g Bonding resin A , 1 X 7g Bonding resin B , 1 X 9g liquid Etchant and 1 X plastic Conditioner . Contains Fluoride. FDA UDI

Identifiers

Catalog Number
EHJF FDA UDI
Primary DI / UDI-DI
D798EHJF0 FDA UDI
510(k) Number
K875141 FDA UDI
K880792 FDA UDI
FDA Product Code
DYH FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3750 FDA UDI
Commercial Distribution
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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dentine bonding agent/setOrthodontic bracket adhesive

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

Similar devices

Also classified as Orthodontic bracket adhesive.

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 5ba3042e-a61b-428e-b709-3130057437cb 37 fields · synced Jun 8, 2026