meddevicedb.com FDA Device Reference

COOLBLU2 DENTAL RESIN CURING DEVICE

K020171 Class II Special
Decision Date
2002-01-29
Sponsor / Applicant
Dental Systems.Com, Inc.

Technical Specification

510(k) Submission ID K020171
Product Code EBZ
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.6070
Decision Date 2002-01-29
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

COOLBLU2 DENTAL RESIN CURING DEVICE received FDA 510(k) clearance under submission number K020171, sponsored by Dental Systems.Com, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-01-29.

Classification & Regulation

This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.