Cleared Traditional

K072733 - 3M ESPE ADULT CROWN

K072733 is the FDA 510(k) clearance for 3M ESPE ADULT CROWN by 3M Company. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K072733 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
141d
Days
Class 2
Risk

K072733 is an FDA 510(k) clearance for the 3M ESPE ADULT CROWN. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Company (St Paul, US). The FDA issued a Cleared decision on February 15, 2008 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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

Submission Details

510(k) Number K072733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date February 15, 2008
Days to Decision 141 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
14d slower than avg
Panel avg: 127d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 515
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K072733.
GRADIA CORE
K082171 · GC America, Inc. · Oct 2008
GRADIA FORTE
K080478 · GC America, Inc. · Jun 2008
BEAUTIFIL OPAQUER
K080068 · Shofu Dental Corp. · Feb 2008
BEAUTIFIL II
K071742 · Shofu Dental Corp. · Aug 2007
MODIFICATION TO KAVO QUATTROCARE
K071288 · Sybron Dental Specialties, Inc. · Jul 2007
CLEARFIL MAJESTY POSTERIOR PLT
K071169 · Kuraray Medical, Inc. · Jun 2007