Cleared Traditional

DDS-ZR (K041645) - FDA 510(k) Clearance

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

K041645 · Charles Scharf · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
22d
Days
Class 2
Risk

K041645 is an FDA 510(k) clearance for the DDS-ZR. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Charles Scharf (Englewood, US). The FDA issued a Cleared decision on July 9, 2004 after a review of 22 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 Charles Scharf devices

Submission Details

510(k) Number K041645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2004
Decision Date July 09, 2004
Days to Decision 22 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
105d faster than avg
Panel avg: 127d · This submission: 22d
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 K041645.
MODIFICATION TO: CERCON BASE
K051462 · Dentsply Intl. · Jun 2005
DUCERA ALLCERAM
K043247 · Dentsply Intl. · Dec 2004
CERCON CERAM EXPRESS CERAMIC SYSTEM
K041707 · Dentsply Intl. · Jul 2004
CARRARA INTERACTION CERAMIC SYSTEM
K040635 · Dentsply Intl. · Mar 2004
DUCERAM PLUS CERAMIC SYSTEM
K040420 · Dentsply Intl. · Mar 2004
DUCERAGOLD PORCELAINS
K040421 · Dentsply Intl. · Mar 2004