Cleared Traditional

K030168 - AGC CEM

K030168 is an FDA 510(k) clearance for AGC CEM, manufactured by Wieland Dental + Technik GmbH & Co. KG. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K030168 · Wieland Dental + Technik GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
63d
Days
Class 2
Risk

K030168 is an FDA 510(k) clearance for the AGC CEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on March 21, 2003 after a review of 63 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 Wieland Dental + Technik GmbH & Co. KG devices

FDA 510(k) Submission Details - K030168

510(k) Number K030168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2003
Decision Date March 21, 2003
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 406
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K030168.
GLASIONOMER FX-II
K031467 · Shofu Dental Corp. · Jul 2003
TEMPORARY RESIN CEMENT
K031212 · Parkell, Inc. · Jul 2003
RIVA-SELF CURE
K030516 · Southern Dental Industries, Inc. · Apr 2003
VITIQUE SYSTEM
K023649 · Dmg USA, Inc. · Jan 2003
TEMPORARY CEMENT-DC010002
K023727 · GC America, Inc. · Jan 2003
RELYX RMGIP
K022476 · 3M Company · Aug 2002