Cleared Traditional

K043472 - MEDIN TECH ZIRCONIA-CP10, SS1000

K043472 is an FDA 510(k) clearance for MEDIN TECH ZIRCONIA-CP10, manufactured by Medin Tech. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K043472 · Medin Tech · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
33d
Days
Class 2
Risk

K043472 is an FDA 510(k) clearance for the MEDIN TECH ZIRCONIA-CP10, SS1000. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Medin Tech (St-Laurent (Pq), CA). The FDA issued a Cleared decision on January 18, 2005 after a review of 33 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 Medin Tech devices

FDA 510(k) Submission Details - K043472

510(k) Number K043472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2004
Decision Date January 18, 2005
Days to Decision 33 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
94d faster than avg
Panel avg: 127d · This submission: 33d
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 337
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