Cleared Traditional

QUICK COUPLING DEVICE FOR DENTAL PROSTHESES (K950260) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950260 · Dr. Joseph E. Grasso, D.D.S. · Dental device
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Sep 1997
Decision
960d
Days
Class 2
Risk

K950260 is an FDA 510(k) clearance for the QUICK COUPLING DEVICE FOR DENTAL PROSTHESES. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dr. Joseph E. Grasso, D.D.S. (West Simsbury, US). The FDA issued a Cleared decision on September 9, 1997 after a review of 960 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Dr. Joseph E. Grasso, D.D.S. devices

Submission Details

510(k) Number K950260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1995
Decision Date September 09, 1997
Days to Decision 960 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
833d slower than avg
Panel avg: 127d · This submission: 960d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 303
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