Coltene Orally

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

510(k) Number

K810907 ↗

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 Coltene Orally used for in dental procedures?

  The Coltene Orally is a dental amalgam alloy designed specifically for creating durable restorations in dental cavities. It helps restore the structure and function of teeth by filling cavities and providing long-lasting filling material during standard dental procedures.

• Is the Coltene Orally intended for single-use or can it be reused?

  The Coltene Orally is not a single-use device—it is a reusable dental alloy. It is processed and reused in clinical settings for multiple dental restorations, following proper handling and sterilization protocols for dental materials.

• How is the regulatory status of the Coltene Orally determined?

  The Coltene Orally holds FDA 510(k) clearance (K810907) and is classified as a Class II medical device under product code EJJ. Its regulatory pathway was determined through a traditional 510(k) submission, with the FDA ruling it substantially equivalent to a predicate device, as noted in the decision description.

• What types of dental settings can use the Coltene Orally?

  The Coltene Orally is intended exclusively for clinical dental settings where restorative procedures are performed. It is designed for use by dentists and dental professionals in standard office environments to create amalgam-based fillings for treating cavities.

• Are there different sizes or models of the Coltene Orally?

  The Coltene Orally is supplied as a dental amalgam alloy, and while specific sizes or models are referenced in regulatory records (e.g., FEI numbers), the device itself is not marketed or sold as discrete 'sizes' in the traditional sense. Instead, it is used in various dental procedures based on clinical need, with the alloy being processed and mixed as required for each application.