Cleared Special

K022476 - RELYX RMGIP

K022476 is an FDA 510(k) clearance for RELYX RMGIP, manufactured by 3M Company. The device is a Class 2 Dental device with product code EMA cleared through the Special 510(k) pathway after a 4-day FDA review.

K022476 · 3M Company · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
4d
Days
Class 2
Risk

K022476 is an FDA 510(k) clearance for the RELYX RMGIP. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by 3M Company (St Paul, US). The FDA issued a Cleared decision on August 2, 2002 after a review of 4 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022476

510(k) Number K022476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date August 02, 2002
Days to Decision 4 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 128d · This submission: 4d
Pathway characteristics
Modification to existing cleared device.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 505
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K022476.
VITIQUE SYSTEM
K023649 · Dmg USA, Inc. · Jan 2003
TEMPORARY CEMENT-DC010002
K023727 · GC America, Inc. · Jan 2003
TRIONOMER
K022150 · Pentron Clinical Technologies · Aug 2002
GC ELITE CEMENT 100
K021038 · GC America, Inc. · May 2002
PULPDENT POST CEMENT
K020481 · Pulpdent Corporation · Apr 2002
AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE
K020376 · Advanced Healthcare , Ltd. · Apr 2002
K022476 · RELYX RMGIP
Download PDF FDA Summary 3M Company