Cleared Traditional

K050658 - RESO-PAC PERIODONTAL DRESSING

K050658 is an FDA 510(k) clearance for RESO-PAC PERIODONTAL DRESSING, manufactured by Hager Worldwide, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K050658 · Hager Worldwide, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
74d
Days
Class 2
Risk

K050658 is an FDA 510(k) clearance for the RESO-PAC PERIODONTAL DRESSING. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Hager Worldwide, Inc. (Washington, US). The FDA issued a Cleared decision on May 27, 2005 after a review of 74 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 Hager Worldwide, Inc. devices

FDA 510(k) Submission Details - K050658

510(k) Number K050658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2005
Decision Date May 27, 2005
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 127d · This submission: 74d
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 396
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K050658.
PREMIER TEMPORARY CEMENT
K051866 · Premier Dental Products Co. · Sep 2005
GC FUJI FIL LC
K051427 · GC America, Inc. · Aug 2005
RIVA LIGHT CURE
K050870 · Southern Dental Industries, Inc. · Jun 2005
TEMPOSIL, MODEL 6720
K050426 · Coltene/Whaledent AG · Mar 2005
SYSTEMP.LINK
K042846 · Ivoclar Vivadent, Inc. · Dec 2004
SYSTEMP.CEM
K042847 · Ivoclar Vivadent, Inc. · Dec 2004