Cleared Traditional

K950260 - QUICK COUPLING DEVICE FOR DENTAL PROSTHESES

K950260 is an FDA 510(k) clearance for QUICK COUPLING DEVICE FOR DENTAL PROSTHESES, manufactured by Dr. Joseph E. Grasso, D.D.S.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 960-day FDA review.

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

FDA 510(k) Submission Details - K950260

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
Combination Product No
PCCP Authorized No
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.

DZE Device Classification - Class 2, Special Controls

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 1046
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K950260.
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DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES
K950261 · Dr. Joseph E. Grasso, D.D.S. · Sep 1997
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K961381 · The Emerging Technologies Group · Sep 1997
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K972444 · Implant Innovations, Inc. · Aug 1997