D3 Chroma

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

510(k) Number

K042422 ↗

FDA Product Code

DYH

Device Class

Class II

Regulation

21 CFR Part 872.3750

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Prodigy 4

  Class II

  FDA 510(k) K990898 Active Cleared 6 Apr 1999

• Kerr Gel Etchant

  Class II

  FDA 510(k) K000954 Active Cleared 28 Apr 2000

• Sealapex 4

  Class II

  FDA 510(k) K010940 Active Cleared 20 Jun 2001

• Point 4 Flowable

  Class II

  FDA 510(k) K012321 Active Cleared 27 Aug 2001

• Temp-Bond Ne 2

  Class II

  FDA 510(k) K003658 Active Cleared 4 Jan 2001

• Extrude

  Class II

  FDA 510(k) K940379 Active Cleared 22 Mar 1994

See all devices from Sybron Dental Specialties, Inc. →

• What is the D3 Chroma used for in orthodontic treatment?

  The D3 Chroma is an adhesive, bracket, and tooth conditioner resin designed specifically to prepare tooth surfaces for bonding orthodontic brackets and restorative materials. By conditioning the enamel, it enhances adhesion, ensuring that brackets and restorations remain durable and long-lasting throughout treatment.

• How is the D3 Chroma supplied, and is it reusable?

  The D3 Chroma is supplied in sterile, pre-filled applicators intended for single-use only. This ensures contamination-free application and maintains the integrity of the adhesive properties for each patient.

• Does the D3 Chroma require any special storage conditions?

  The provided documentation does not specify any special storage conditions for the D3 Chroma. However, as with all sterile medical devices, it should be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures, to preserve sterility and performance.

• Is the D3 Chroma approved for use in dental procedures?

  Yes, the D3 Chroma has received FDA 510(k) clearance (K042422) and is classified as a Class II medical device. It is authorized under the Dental advisory committee and FDA regulation 872.3750, confirming its compliance for professional dental use.

• Are there different models or sizes available for the D3 Chroma?

  The D3 Chroma is supplied in pre-filled applicators, but no specific variations in sizes or models are mentioned in the provided data. The device is standardized for general orthodontic and restorative applications, ensuring consistent performance across uses.