Not Cleared Post-NSE

DEN980003 - DIAMOND PROBE/PERIO 2000 SYSTEM (FDA 510(k) Clearance)

Class II Dental device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN980003 · Diamond General Development Corp. · Dental device
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Jul 1998
Decision
60d
Days
Class 2
Risk

DEN980003 is an FDA 510(k) submission (not cleared) for the DIAMOND PROBE/PERIO 2000 SYSTEM. Classified as Device, Detection, Sulfide (product code MVH), Class II - Special Controls.

Submitted by Diamond General Development Corp. (Ann Arbor, US). The FDA issued a Not Cleared (DENG) decision on July 17, 1998 after a review of 60 days.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1870 - the FDA dental device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Dental review framework.

View all Diamond General Development Corp. devices

Submission Details

510(k) Number DEN980003 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 18, 1998
Decision Date July 17, 1998
Days to Decision 60 days
Submission Type Post-NSE
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics

Device Classification

Product Code MVH Device, Detection, Sulfide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.