IDEAL 1 Orthodontic Band Cement

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

510(k) Number

K040375 ↗

FDA Product Code

DYH

Device Class

Class II

Regulation

21 CFR Part 872.3750

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What is the IDEAL 1 Orthodontic Band Cement used for?

  The IDEAL 1 Orthodontic Band Cement is a light-cure two-part system designed for bonding orthodontic bands to both natural and artificial tooth surfaces. It includes an orthodontic cement and a primer, with an optional tooth conditioner for high-stress bonding applications.

• How is the IDEAL 1 Orthodontic Band Cement supplied?

  The device is supplied as a single-use product intended for use by dental professionals. It includes an orthodontic cement and a primer, with an optional tooth conditioner available for high-stress bonding applications.

• What is the regulatory classification of the IDEAL 1 Orthodontic Band Cement?

  The IDEAL 1 Orthodontic Band Cement is regulated under FDA 510(k) clearance (K040375) and is classified as a Class II device under the Special Controls framework. Proper storage and handling are required to maintain its efficacy.

• Is the IDEAL 1 Orthodontic Band Cement reusable?

  No, the IDEAL 1 Orthodontic Band Cement is supplied as a single-use product and is not intended for reuse. Dental professionals should use a new application for each patient to ensure proper bonding and hygiene.