Cleared Traditional

K950261 - DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES

K950261 is an FDA 510(k) clearance for DEVICE FOR PROVIDING QUICK COUPLING FOR..., 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.

K950261 · Dr. Joseph E. Grasso, D.D.S. · Dental device
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Sep 1997
Decision
960d
Days
Class 2
Risk

K950261 is an FDA 510(k) clearance for the DEVICE FOR PROVIDING QUICK COUPLING 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 - K950261

510(k) Number K950261 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 K950261.
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K961381 · The Emerging Technologies Group · Sep 1997
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K972444 · Implant Innovations, Inc. · Aug 1997
THE PERIOSEAL DENTAL IMPLANT
K965032 · Perioseal · Aug 1997