Cleared Traditional

K101869 - PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)

K101869 is an FDA 510(k) clearance for PROGLASS CEMENTS (ONE, manufactured by Silmet , Ltd.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K101869 · Silmet , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
89d
Days
Class 2
Risk

K101869 is an FDA 510(k) clearance for the PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER). Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Silmet , Ltd. (Or Yehuda, IL). The FDA issued a Cleared decision on September 29, 2010 after a review of 89 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 Silmet , Ltd. devices

FDA 510(k) Submission Details - K101869

510(k) Number K101869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2010
Decision Date September 29, 2010
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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 374
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K101869.
VOCO IONOFIL MOLAR AC QUICK
K102612 · Voco GmbH · Nov 2010
TI-CORE FLOW
K101504 · Essential Dental Systems, Inc. · Oct 2010
DUOLINK II
K101787 · Bisco, Inc. · Oct 2010
GC FUJI TEMP
K101420 · GC America, Inc. · Sep 2010
ADVANCED GLASS IONOMER (K-130) RESTORATIVE
K101493 · Dentsply International, Inc. · Aug 2010
UNICEM HM
K100908 · 3M Espe AG Dental Products · Jun 2010