Light-Cure

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

510(k) Number

K952858 ↗

FDA Product Code

DYH

Device Class

Class II

Regulation

21 CFR Part 872.3750

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Pc-Lock

  Class II

  FDA 510(k) K952855 Active Cleared 8 Sep 1995

• Gluflorma

  Class II

  FDA 510(k) K955740 Active Cleared 8 Feb 1996

• Orthodontic Braces

  Class II

  FDA 510(k) K981433 Active Cleared 25 Jun 1998

• Fluor-I-Chains(Tm) and Fluor-I-Ties(Tm)

  Class I

  FDA 510(k) K900824 Active Cleared 22 May 1990

• Pro-Lock

  Class II

  FDA 510(k) K952857 Active Cleared 5 Sep 1995

• Light-Cure Pc

  Class II

  FDA 510(k) K952856 Active Cleared 12 Sep 1995

• What types of dental applications is the Light-Cure adhesive system intended for, and how does it differ from traditional bonding methods?

  The Light-Cure adhesive system is specifically designed for orthodontic applications, enabling secure attachment of brackets and tooth conditioners to teeth through a light-activated polymerization process. Unlike traditional bonding methods that rely on chemical curing, this system uses a curing light to harden the resin, ensuring a durable and long-lasting bond during orthodontic treatment. This method is particularly useful in clinical settings where precision and stability are critical.

• Is the Light-Cure system single-use or reusable, and how should it be stored to maintain its performance?

  The Light-Cure system can be supplied as either reusable or single-use, depending on the specific resin variant. To maintain sterility and performance, it must be stored according to the manufacturer’s guidelines, which likely include protection from moisture, extreme temperatures, and direct light. Proper storage ensures the adhesive properties remain intact for reliable use in dental procedures.

• What regulatory pathway does the Light-Cure adhesive system follow, and what does the FDA clearance (K952858) under product code DYH indicate?

  The Light-Cure adhesive system holds an FDA 510(k) clearance (K952858) under product code DYH, classified as a Class II medical device. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness in dental adhesive and resin applications. The classification (872.3750) confirms its use in orthodontic bonding procedures.

• Are there any special handling considerations for the Light-Cure system, such as MRI safety or compatibility with other dental equipment?

  The Light-Cure system is explicitly noted as not MRI-safe, meaning it should not be used or stored in environments where MRI scans are performed. Additionally, since it relies on a light-activated curing process, compatibility with standard dental curing lights is assumed, but clinicians should verify compatibility with their specific equipment to ensure optimal performance and bonding results.