Cleared Traditional

K042548 - CERASYS - ZR

K042548 is an FDA 510(k) clearance for CERASYS - ZR, manufactured by Cerasys, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K042548 · Cerasys, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
74d
Days
Class 2
Risk

K042548 is an FDA 510(k) clearance for the CERASYS - ZR. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Cerasys, Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on December 3, 2004 after a review of 74 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 Cerasys, Inc. devices

FDA 510(k) Submission Details - K042548

510(k) Number K042548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date December 03, 2004
Days to Decision 74 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
53d faster than avg
Panel avg: 127d · This submission: 74d
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 338
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K042548.
WILLI GELLER CREATION ZI PORCELAIN
K043201 · Jensen Industries, Inc. · Jan 2005
DUCERA ALLCERAM
K043247 · Dentsply Intl. · Dec 2004
WILLI GELLER CREATION CP PORCELAIN
K043221 · Jensen Industries, Inc. · Dec 2004
CERCON CERAM EXPRESS CERAMIC SYSTEM
K041707 · Dentsply Intl. · Jul 2004
NOBELRONDO DENTAL CERAMIC-ALUMINA
K041312 · Nobel Biocare Uas, Inc. · Jul 2004
PTM SYSTEM
K041335 · Dentsply International · Jun 2004