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DR GREENBURGS HYBRID ACRYLIC

K120371 Class II Abbreviated
Decision Date
2012-06-27
Sponsor / Applicant
Always More Marketing, Inc.

Technical Specification

510(k) Submission ID K120371
Product Code LRK
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.5570
Decision Date 2012-06-27
Clearance Pathway Abbreviated

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

DR GREENBURGS HYBRID ACRYLIC received FDA 510(k) clearance under submission number K120371, sponsored by Always More Marketing, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-06-27.

Classification & Regulation

This clearance is catalogued under FDA product code LRK and 21 CFR 872.5570, within the Dental review panel as a Class II device.