Coltene Oralloy Magicaps

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

510(k) Number

K840297 ↗

FDA Product Code

EJJ

Device Class

Class II

Regulation

21 CFR Part 872.3070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Coltene Pressure Spot Indicator

  Class II

  FDA 510(k) K811667 Active Cleared 15 Jul 1981

• Coltene President Jet Regular Body

  Class II

  FDA 510(k) K882800 Active Cleared 23 Sep 1988

• Cool Temp Natural

  Class II

  FDA 510(k) K041098 Active Cleared 13 May 2004

• Coltene President Impression Materials

  Class II

  FDA 510(k) K811767 Active Cleared 15 Jul 1981

• Coltene Jet-Mixer

  Class I

  FDA 510(k) K863998 Active Cleared 30 Oct 1986

• Coltene Coltex/Coltoflax

  Class II

  FDA 510(k) K811666 Active Cleared 15 Jul 1981

See all devices from Coltene, Inc. →

• What is the Oralloy Magicaps dental alloy system used for?

  The Coltene Oralloy Magicaps is designed specifically for creating durable dental fillings in teeth during restorative procedures. The premeasured capsules contain a dental amalgam alloy formulated to provide strength, longevity, and biocompatibility with oral tissues, ensuring long-term performance and patient comfort.

• How are Oralloy Magicaps supplied and intended for use?

  Oralloy Magicaps are supplied as single-use capsules, meaning each capsule is intended for one-time clinical use only. This design ensures sterility and prevents cross-contamination between patients. They are exclusively intended for use in clinical dental settings by trained dental professionals.

• Are Oralloy Magicaps sterile and how should they be stored?

  While the device data does not explicitly state sterility, the single-use nature of Oralloy Magicaps implies they are intended to be sterile upon packaging. To maintain sterility and performance integrity, storage must comply with standard dental practice protocols, including keeping them in a clean, dry environment away from direct sunlight and extreme temperatures.

• What regulatory approval does the Oralloy Magicaps dental alloy system have?

  The Coltene Oralloy Magicaps has received FDA 510(k) clearance (K840297) as substantially equivalent to a predicate device. It is classified as a Class II medical device under FDA regulation 872.3070, which governs dental alloys and amalgam systems. This clearance confirms its compliance with U.S. safety and performance standards for dental restorative procedures.

• Are there different sizes or models of Oralloy Magicaps available?

  The device data lists multiple registration numbers (e.g., 3010862763, 3013557562) under the product code EJJ, which may correspond to different capsule sizes or formulations. While the exact specifications for each variant are not detailed here, these variations likely cater to different clinical needs, such as varying filling sizes or patient-specific requirements. For precise sizing details, refer to the manufacturer’s product documentation.