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SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156

K001463 Class II Traditional
Decision Date
2000-06-16
Sponsor / Applicant
Davis Schottlander & Davis, Ltd.

Technical Specification

510(k) Submission ID K001463
Product Code EBI
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.3760
Decision Date 2000-06-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 received FDA 510(k) clearance under submission number K001463, sponsored by Davis Schottlander & Davis, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-06-16.

Classification & Regulation

This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.