Cleared Abbreviated

K113040 - CERAMIR CROWN & BRIDGE

K113040 is the FDA 510(k) clearance for CERAMIR CROWN & BRIDGE by Doxa Dental AB. It is a Class 2 Dental device (product code EMA) cleared through the Abbreviated 510(k) pathway after a 77-day FDA review.

K113040 · Doxa Dental AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
77d
Days
Class 2
Risk

K113040 is an FDA 510(k) clearance for the CERAMIR CROWN & BRIDGE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Doxa Dental AB (Uppsala, SE). The FDA issued a Cleared decision on December 28, 2011 after a review of 77 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Doxa Dental AB devices

Submission Details

510(k) Number K113040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2011
Decision Date December 28, 2011
Days to Decision 77 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 127d · This submission: 77d
Pathway characteristics
Standards-based clearance path.

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 255
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K113040.
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S
K120378 · Kuraray Medical, Inc. · Mar 2012
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S
K120379 · Kuraray Medical, Inc. · Mar 2012
RESIGLASS PASTE
K112307 · Shofu Dental Corporation · Mar 2012
HY-BOND RESIGLASS
K111855 · Shofu Dental Corp. · Nov 2011
PERMASHADE VENEER CEMENT
K111836 · Ultradent Products, Inc. · Sep 2011
IP TEMP CEMENT
K111685 · Shofu Dental Corporation · Sep 2011