Cleared Traditional

K992489 - 3M TR SYSTEM

K992489 is an FDA 510(k) clearance for 3M TR SYSTEM, manufactured by 3M Company. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K992489 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
169d
Days
Class 2
Risk

K992489 is an FDA 510(k) clearance for the 3M TR SYSTEM. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on January 11, 2000 after a review of 169 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all 3M Company devices

FDA 510(k) Submission Details - K992489

510(k) Number K992489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date January 11, 2000
Days to Decision 169 days
Submission Type Traditional
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
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 401
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K992489.
WILLI GELLER CREATION & AV PORCELAIN
K002041 · Jensen Industries, Inc. · Aug 2000
VITA RESPONSE
K000597 · Vident · May 2000
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
K994435 · Jeneric/Pentron, Inc. · Feb 2000
CERGOGOLD
K993897 · Degussa - Ney Dental, Inc. · Jan 2000
OPC LOW WEAR OPAQUE PORCELAIN
K993249 · Jeneric/Pentron, Inc. · Nov 1999
DENZIR
K984201 · Dentronic AB · Sep 1999