Cleared Traditional

K974622 - DENTAL D

K974622 is an FDA 510(k) clearance for DENTAL D, manufactured by Micro Dental Laboratories. The device is a Class 1 Dental device with product code EHP cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K974622 · Micro Dental Laboratories · Dental device
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Feb 1998
Decision
61d
Days
Class 1
Risk

K974622 is an FDA 510(k) clearance for the DENTAL D. Classified as Clasp, Preformed (product code EHP), Class I - General Controls.

Submitted by Micro Dental Laboratories (Dublin, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3285 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K974622

510(k) Number K974622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1997
Decision Date February 10, 1998
Days to Decision 61 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
67d faster than avg
Panel avg: 128d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

EHP Device Classification - Class 1, General Controls

Product Code EHP Clasp, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3285
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 - EHP Clasp, Preformed

Devices cleared under the same product code (EHP) and FDA review panel - the closest regulatory comparables to K974622.
ACETAL
K022032 · Inovativ, LLC · Aug 2002
ACETAL DENTAL/PREFORMED CLASP
K983558 · Dentamax, Inc. · Jan 1999
ACETAL DENTAL/PREFORMED CLASP
K954971 · B & H Technical Services , Ltd. · Dec 1995
ACETAL DENTAL/PREFORMED CLASP
K955946 · Pressing DI Monticelli Rag. Stefano · Dec 1995
INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH
K854765 · C&C Systems, Inc. · Jun 1986
K974622 · DENTAL D
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