American Dental Products Paste-Primer Adhesive Orthodontic Bonding System W/Fluoride

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K954373 ↗

FDA Product Code

DYH

FDA applicant

American Dental Products, Inc.

Device Class

Class II

Regulation

21 CFR Part 872.3750

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• American Dental Products Hb-35 Desensitizer with Fluoride

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• American Dental Products Two Paste Adhesive Orthodontic Bonding System W/Fluoride

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See all devices from American Dental Products Inc →

• What is the American Dental Products Paste-Primer Adhesive Orthodontic Bonding System With Fluoride used for?

  This is a two-paste adhesive bonding system specifically designed for bonding orthodontic brackets to teeth in dental applications. The system includes fluoride, which may help prevent tooth decay around the bonded area.

• How is the Paste-Primer Adhesive Orthodontic Bonding System supplied?

  The device is supplied as a complete bonding system containing two pastes that work together for effective orthodontic bracket adhesion. It is intended for single-use applications only and should not be reused for patient safety and effectiveness.

• What is the regulatory status of this orthodontic bonding system?

  This device has received FDA 510(k) clearance with K number K954373 and is classified under product code DYH. It is regulated under regulation number 872.3750 and is considered substantially equivalent to other devices in this category.

• Is the Paste-Primer Adhesive Orthodontic Bonding System sterile?

  The device description does not specify sterility information. As a single-use product intended for dental applications, it should be handled according to standard infection control protocols, but specific sterility claims are not mentioned in the provided data.