Cleared Traditional

K070537 - ZIRBLOCK

K070537 is an FDA 510(k) clearance for ZIRBLOCK, manufactured by Cdl Technologies, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K070537 · Cdl Technologies, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
63d
Days
Class 2
Risk

K070537 is an FDA 510(k) clearance for the ZIRBLOCK. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Cdl Technologies, Inc. (Deer Field, US). The FDA issued a Cleared decision on April 30, 2007 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K070537

510(k) Number K070537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2007
Decision Date April 30, 2007
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
65d faster than avg
Panel avg: 128d · This submission: 63d
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 K070537.
GC-ZIRCONIA
K071674 · GC America, Inc. · Aug 2007
ZEO CE LIGHT & ZEO QUICK PORCELAIN
K071201 · Xpdent Corp · Jul 2007
AVANTE Z
K070699 · Pentron Ceramics, Inc. · Jun 2007
PRESSX ZR
K070772 · Wieland Dental + Technik GmbH & Co. KG · Apr 2007
CYRTINA SYSTEM
K063842 · Oratio B.V. · Apr 2007
ZIRBLANK-PS AND ZIRBLANK-FS
K070045 · Acucera, Inc. · Mar 2007
K070537 · ZIRBLOCK
Download PDF FDA Summary Cdl Technologies, Inc.