Cleared Traditional

K062389 - Z-BLOCK, MODELS 20/19, 40/19, 55/19

K062389 is an FDA 510(k) clearance for Z-BLOCK, manufactured by Foundation Milling Centre. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K062389 · Foundation Milling Centre · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
5d
Days
Class 2
Risk

K062389 is an FDA 510(k) clearance for the Z-BLOCK, MODELS 20/19, 40/19, 55/19. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Foundation Milling Centre (Clearwater, US). The FDA issued a Cleared decision on August 21, 2006 after a review of 5 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.

View all Foundation Milling Centre devices

FDA 510(k) Submission Details - K062389

510(k) Number K062389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2006
Decision Date August 21, 2006
Days to Decision 5 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 127d · This submission: 5d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 325
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K062389.
CARRARA VOLUMIA
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GLASS CERAMICS
K053438 · 3M Espe AG Dental Products · Jan 2006
VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX
K052710 · Vident · Jan 2006