American Dental Products (Adp), Fluoride Releasing Glass Ionomer Band Cement

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

510(k) Number

K950512 ↗

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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  Class II

  FDA 510(k) K093014 Active Cleared 16 Apr 2010

• American Dental Products Hg 35 Desensitizer with Fluoride

  Class II

  FDA 510(k) K964133 Active Cleared 9 Jan 1997

• American Dental Products Alginate Flavoring

  Class II

  FDA 510(k) K954223 Active Cleared 29 Sep 1995

• American Dental Products Hb-35 Desensitizer with Fluoride

  Class II

  FDA 510(k) K973185 Active Cleared 14 Nov 1997

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

  Class II

  FDA 510(k) K954372 Active Cleared 17 Oct 1995

• American Dental Prodducts Light Activated Composite Resin Core Paste with Fluoride

  Class II

  FDA 510(k) K954405 Active Cleared 30 Oct 1995

See all devices from American Dental Products Inc →

• What is the primary purpose of this fluoride-releasing glass ionomer band cement in orthodontic treatment?

  This fluoride-releasing glass ionomer band cement is designed to bond orthodontic brackets securely to teeth while actively releasing fluoride. The fluoride helps prevent tooth decay, supporting both restorative and preventive dental care during orthodontic treatment.

• Is this product intended for single-use or can it be reused?

  The product is explicitly supplied as a dental adhesive intended for single-use in orthodontic applications. Reuse is not recommended or supported by the manufacturer’s specifications.

• Are there multiple sizes or models available for this fluoride-releasing glass ionomer cement?

  The data lists multiple FEI numbers (e.g., 3010862763, 1815540), which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, these identifiers suggest the product may be available in various packaging or batch configurations, but no specific size or model variations are described in the provided details.

• Does this product require any special storage conditions?

  The provided data does not specify any special storage requirements such as temperature, humidity, or light sensitivity. However, as with most dental adhesives, it is generally recommended to store it in a cool, dry place away from direct sunlight until use, following standard dental supply protocols.

• What regulatory pathway was followed for this product’s FDA clearance?

  This product received FDA 510(k) clearance under the classification of an adhesive, bracket, and tooth conditioner (product code DYH). The submission was reviewed by the Dental (DE) Advisory Committee and determined to be substantially equivalent to a predicate device, falling under Class II – Special Controls (regulation 872.3750). The clearance was granted on March 7, 1995, following a traditional review process.