Cleared Traditional

K082137 - DLMS-ZIRBLOCKS

K082137 is an FDA 510(k) clearance for DLMS-ZIRBLOCKS, manufactured by Dental Milling Laboratory Supplies (Dlms). The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K082137 · Dental Milling Laboratory Supplies (Dlms) · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
196d
Days
Class 2
Risk

K082137 is an FDA 510(k) clearance for the DLMS-ZIRBLOCKS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dental Milling Laboratory Supplies (Dlms) (Scottsdale, US). The FDA issued a Cleared decision on February 10, 2009 after a review of 196 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K082137

510(k) Number K082137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2008
Decision Date February 10, 2009
Days to Decision 196 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
68d slower than avg
Panel avg: 128d · This submission: 196d
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 479
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K082137.
NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100
K091096 · Dental Solutions, Inc. · Jun 2009
AVANTE LEUCITE BLOCKS
K090684 · Somerset Dental Products, Inc. · May 2009
VITABLOCS, MODEL VX55-****
K090644 · Vita Zahnfabrik H.Rauter GmbH & Co. · Mar 2009
ZMATCH BLOCK
K083201 · Dentaim Co., Ltd. · Jan 2009
BITTAR ZIRCONIA BLOCKS
K082652 · Bittar Zirconia Block, LLC · Dec 2008
GC AADVA ZR DISK
K082740 · GC America, Inc. · Nov 2008
K082137 · DLMS-ZIRBLOCKS
Download PDF FDA Summary Dental Milling Labora…