Cleared Abbreviated

K081405 - XERACEM

K081405 is the FDA 510(k) clearance for XERACEM by Doxa Dental AB. It is a Class 2 Dental device (product code EMA) cleared through the Abbreviated 510(k) pathway after a 94-day FDA review.

K081405 · Doxa Dental AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
94d
Days
Class 2
Risk

K081405 is an FDA 510(k) clearance for the XERACEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Doxa Dental AB (Washington, US). The FDA issued a Cleared decision on August 21, 2008 after a review of 94 days - within the typical 510(k) review window.

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 K081405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date August 21, 2008
Days to Decision 94 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
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 K081405.
SPEEDCEM
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BISCEM TRANSLUCENT, MODEL D-45011
K082449 · Bisco, Inc. · Sep 2008
CLEARFIL SA CEMENT
K081583 · Kuraray Medical, Inc. · Jul 2008
RESICEM
K080517 · Shofu Dental Corp. · Jun 2008
ULTRATEMP FIRM, FAST AND REGULAR SET
K080768 · Ultradent Products, Inc. · Apr 2008