Cleared Traditional

K093571 - ZR DENTAL BLOCK

K093571 is an FDA 510(k) clearance for ZR DENTAL BLOCK, manufactured by Ams Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K093571 · Ams Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
114d
Days
Class 2
Risk

K093571 is an FDA 510(k) clearance for the ZR DENTAL BLOCK. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Ams Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on March 12, 2010 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ams Co., Ltd. devices

FDA 510(k) Submission Details - K093571

510(k) Number K093571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2009
Decision Date March 12, 2010
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 307
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K093571.
ZENOSTAR MAGIC GLAZE
K103494 · Wieland Dental + Technik GmbH & Co. KG · Feb 2011
NOBELPROCERA IPS E.MAX CROWN
K100512 · Nobel Biocare AB · Aug 2010
OBSIDIAN CERAMIC BLOCKS
K100781 · Prismatik Dentalcraft, Inc. · Jun 2010
VINTAGE MP
K093559 · Shofu Dental Corp. · Mar 2010
RAINBOW BLOCK
K092513 · Genoss Co., Ltd. · Oct 2009
AADVA ZR COLORING LIQUID
K092020 · GC America, Inc. · Sep 2009