Cleared Traditional

K021971 - CERALOY

K021971 is an FDA 510(k) clearance for CERALOY, manufactured by Neirynck & Vogt NV. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K021971 · Neirynck & Vogt NV · Dental device
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Aug 2002
Decision
45d
Days
Class 2
Risk

K021971 is an FDA 510(k) clearance for the CERALOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Neirynck & Vogt NV (Pickerington, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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.

View all Neirynck & Vogt NV devices

FDA 510(k) Submission Details - K021971

510(k) Number K021971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2002
Decision Date August 01, 2002
Days to Decision 45 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
82d faster than avg
Panel avg: 127d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 100
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