Cleared Traditional

Y-TZP POWDER AND PROCERA ALLZIRKON (K010630) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010630 · Procera Sandvik, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
46d
Days
Class 2
Risk

K010630 is an FDA 510(k) clearance for the Y-TZP POWDER AND PROCERA ALLZIRKON. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Procera Sandvik, Inc. (Fair Lawn, US). The FDA issued a Cleared decision on April 17, 2001 after a review of 46 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 Procera Sandvik, Inc. devices

Submission Details

510(k) Number K010630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2001
Decision Date April 17, 2001
Days to Decision 46 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
81d faster than avg
Panel avg: 127d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 165
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K010630.
CARRARA PRESS SYSTEM
K033667 · Dentsply Intl. · Jan 2004
PFZ PORCELAIN SYSTEM
K033553 · Dentsply Intl. · Dec 2003
CERCON CERAM S PORCELAIN
K022796 · Dentsply Intl. · Sep 2002
3M TR SYSTEM
K992489 · 3M Company · Jan 2000
FINESSE ALL-CERAMIC SYSTEM
K971869 · Dentsply Intl. · Sep 1997
FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS
K961291 · Dentsply Intl. · May 1996