Cleared Traditional

K050426 - TEMPOSIL, MODEL 6720

K050426 is an FDA 510(k) clearance for TEMPOSIL, manufactured by Coltene/Whaledent AG. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K050426 · Coltene/Whaledent AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
28d
Days
Class 2
Risk

K050426 is an FDA 510(k) clearance for the TEMPOSIL, MODEL 6720. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Coltene/Whaledent AG (New York, US). The FDA issued a Cleared decision on March 18, 2005 after a review of 28 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 Coltene/Whaledent AG devices

FDA 510(k) Submission Details - K050426

510(k) Number K050426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2005
Decision Date March 18, 2005
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 127d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K050426.
SET
K051008 · Southern Dental Industries, Ltd. · Jun 2005
RIVA LIGHT CURE
K050870 · Southern Dental Industries, Inc. · Jun 2005
RESO-PAC PERIODONTAL DRESSING
K050658 · Hager Worldwide, Inc. · May 2005
SYSTEMP.LINK
K042846 · Ivoclar Vivadent, Inc. · Dec 2004
SYSTEMP.CEM
K042847 · Ivoclar Vivadent, Inc. · Dec 2004
RIVA SILVER
K042452 · Southern Dental Industries, Inc. · Dec 2004