Cleared Traditional

K040906 - CALIBRA CEMENT

K040906 is the FDA 510(k) clearance for CALIBRA CEMENT by Dentsply Intl.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K040906 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
70d
Days
Class 2
Risk

K040906 is an FDA 510(k) clearance for the CALIBRA CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 16, 2004 after a review of 70 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply Intl. devices

Submission Details

510(k) Number K040906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2004
Decision Date June 16, 2004
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 291
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K040906.
DYRACT CEM PLUS CEMENT
K041272 · Dentsply Intl. · Oct 2004
RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
K042215 · Premier Dental Products Co. · Sep 2004
MAXCEM
K041474 · Sybron Dental Specialties, Inc. · Jul 2004
INTEGRITY TEMPORARY CEMENT
K040895 · Dentsply Intl. · May 2004
PULPDENT VLC RESIN CEMENT
K040236 · Pulpdent Corporation · Apr 2004
PREMIER IMPLANT CEMENT, MODEL 3001450
K033309 · Premier Dental Products Co. · Jan 2004