Cleared Traditional

K950259 - COUPLING DEVICE FOR DENTAL PROSTHESIS

K950259 is an FDA 510(k) clearance for COUPLING DEVICE FOR DENTAL PROSTHESIS, manufactured by Dr. Joseph E. Grasso, D.D.S.. The device is a Class 1 Dental device with product code EGG cleared through the Traditional 510(k) pathway after a 683-day FDA review.

K950259 · Dr. Joseph E. Grasso, D.D.S. · Dental device
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Dec 1996
Decision
683d
Days
Class 1
Risk

K950259 is an FDA 510(k) clearance for the COUPLING DEVICE FOR DENTAL PROSTHESIS. Classified as Attachment, Precision, All (product code EGG), Class I - General Controls.

Submitted by Dr. Joseph E. Grasso, D.D.S. (West Simsbury, US). The FDA issued a Cleared decision on December 6, 1996 after a review of 683 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3165 - 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 - K950259

510(k) Number K950259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1995
Decision Date December 06, 1996
Days to Decision 683 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
556d slower than avg
Panel avg: 127d · This submission: 683d
Pathway characteristics
Predicate-based equivalence.

EGG Device Classification - Class 1, General Controls

Product Code EGG Attachment, Precision, All
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3165
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EGG Attachment, Precision, All

All 8
Devices cleared under the same product code (EGG) and FDA review panel - the closest regulatory comparables to K950259.
STECO-TITANMAGNETICS
K990979 · Steco-System-Technik GmbH & Cokg · Sep 1999
DENTAL CONNECTOR PRECISION ATTACHMENT
K912435 · Metalor Dental USA Corp. · Aug 1991
CONICAST, INTRACAST, OMECAST
K912567 · Metalor Dental USA Corp. · Jul 1991
INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH
K901928 · Interpore Intl. · Jul 1990
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K870331 · Interpore Intl. · Mar 1987
DYNA SYSTEM
K855167 · Parker Laboratories, Inc. · Mar 1986