Cleared Special

K022476 - RELYX RMGIP

K022476 is the FDA 510(k) clearance for RELYX RMGIP by 3M Company. It is a Class 2 Dental device (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)
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.

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Submission Details

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
123d faster than avg
Panel avg: 127d · This submission: 4d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K022476.
TEMPORARY RESIN CEMENT
K031212 · Parkell, Inc. · Jul 2003
AGC CEM
K030168 · Wieland Dental + Technik GmbH & Co. KG · Mar 2003
TEMPORARY CEMENT-DC010002
K023727 · GC America, Inc. · Jan 2003
GC ELITE CEMENT 100
K021038 · GC America, Inc. · May 2002
GC FUJI LINING LC PASTE PAK
K020117 · GC America, Inc. · Feb 2002
SCI-PHARM POST SECURE
K013555 · Scientific Pharmaceuticals, Inc. · Jan 2002