meddevicedb.com FDA Device Reference

DIAMOND PROBE/PERIO 2000 SYSTEM

DEN980003 Class II Post-NSE
Decision Date
1998-07-17
Sponsor / Applicant
Diamond General Development Corp.

Technical Specification

510(k) Submission ID DEN980003
Product Code MVH
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.1870
Decision Date 1998-07-17
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

DIAMOND PROBE/PERIO 2000 SYSTEM received FDA 510(k) clearance under submission number DEN980003, sponsored by Diamond General Development Corp.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-07-17.

Classification & Regulation

This clearance is catalogued under FDA product code MVH and 21 CFR 872.1870, within the Dental review panel as a Class II device.