Insta-Bond

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

510(k) Number

K810517 ↗

FDA Product Code

DYH

Device Class

Class II

Regulation

21 CFR Part 872.3750

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Precise(R) Beta Quartz Glass-Ceramic Insert

  Class II

  FDA 510(k) K912256 Active Cleared 24 Jul 1991

• Lee Endofill, Root Canal Filling Resin

  Class II

  FDA 510(k) K810923 Active Cleared 21 Apr 1981

• Ultraviolet Rad-Emitting Lamp

  Class II

  FDA 510(k) K771077 Active Cleared 24 Jun 1977

• Restobond 3/Dentin-Enamel Bonding Agent

  Class II

  FDA 510(k) K894315 Active Cleared 31 Oct 1989

• Cleanse N Bond I

  Class II

  FDA 510(k) K844133 Active Cleared 4 Jan 1985

• Restodent Vl

  Class II

  FDA 510(k) K843363 Active Cleared 25 Oct 1984

See all devices from Lee Pharmaceuticals →

• What is the primary purpose of the INSTA-BOND dental adhesive system, and how does it differ from other dental adhesives?

  The INSTA-BOND is specifically designed as a dental adhesive, bracket, and tooth conditioner resin to bond orthodontic brackets securely to teeth during orthodontic treatment. Unlike generic dental adhesives, it combines adhesive properties with bracket attachment and tooth conditioning in a single-use system, ensuring durable adhesion throughout the orthodontic process. This dual functionality simplifies the clinical workflow by reducing the need for separate products.

• Is INSTA-BOND intended for single-use or repeated applications, and how should it be stored?

  INSTA-BOND is supplied as a single-use dental adhesive system, meaning each package is meant for one patient application only. While the provided data does not specify storage conditions, as a dental adhesive regulated under FDA standards (872.3750), it should be stored according to manufacturer guidelines—typically in a cool, dry place, away from direct sunlight, and protected from contamination until use. Always verify the packaging for any specific storage instructions.

• What regulatory pathway was followed for the FDA clearance of INSTA-BOND, and what does this mean for clinicians?

  INSTA-BOND was cleared through the Traditional 510(k) pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device already on the market. This clearance was granted under the Dental (DE) Advisory Committee and classified as a Class II device (product code DYH). For clinicians, this indicates it meets FDA standards for safety and effectiveness as a dental adhesive, bracket, and tooth conditioner resin, ensuring it can be used with confidence in orthodontic procedures.

• Are there multiple sizes or models of INSTA-BOND available, and if so, how do they differ?

  The provided data lists multiple FEI numbers (e.g., 3010862763, 1815540), which typically correspond to different lot or batch identifiers rather than distinct product sizes or models. However, these identifiers suggest the product may be available in various packaging configurations or formulations, though no specific size or model variations (e.g., different adhesive strengths or bracket types) are described. For precise details on available models, clinicians should consult the manufacturer’s latest labeling or catalog.