Cleared Traditional

K021969 - CHROLOY

K021969 is an FDA 510(k) clearance for CHROLOY, 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 43-day FDA review.

K021969 · Neirynck & Vogt NV · Dental device
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Jul 2002
Decision
43d
Days
Class 2
Risk

K021969 is an FDA 510(k) clearance for the CHROLOY. 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 July 30, 2002 after a review of 43 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.

FDA 510(k) Submission Details - K021969

510(k) Number K021969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2002
Decision Date July 30, 2002
Days to Decision 43 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
85d faster than avg
Panel avg: 128d · This submission: 43d
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 151
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K021969.
JEWEL CAST PLUS
K023502 · Pentron Laboratory Technologies · Dec 2002
BIOLOY
K023477 · Neirynck & Vogt NV · Dec 2002
CERALOY
K021971 · Neirynck & Vogt NV · Aug 2002
CHROLOY SOLDER
K021965 · Neirynck & Vogt NV · Jul 2002
CERALOY SOLDER
K021968 · Neirynck & Vogt NV · Jul 2002
4 ALL (DW286A)
K020253 · Ivoclar Vivadent, Inc. · Apr 2002
K021969 · CHROLOY
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