Who is the manufacturer of CAVEX COLORCHANGE?

Cavex Holland BV submitted the Traditional clearance for CAVEX COLORCHANGE (K011419).

What is the FDA product code for CAVEX COLORCHANGE?

ELW. It is classified under 21 CFR 872.3660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for CAVEX COLORCHANGE?

510(k) clearance (submission type: Traditional).

CAVEX COLORCHANGE

K011419 · Cavex Holland BV · ELW · Jul 16, 2001 · Dental

Device Facts

Record ID	K011419
Device Name	CAVEX COLORCHANGE
Applicant	Cavex Holland BV
Product Code	ELW · Dental
Decision Date	Jul 16, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3660
Device Class	Class 2

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).