Cleared Traditional

K081253 - ZIRDENT CAD/CAM BLOCKS

K081253 is an FDA 510(k) clearance for ZIRDENT CAD/CAM BLOCKS, manufactured by C5 Medical Werks, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K081253 · C5 Medical Werks, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
13d
Days
Class 2
Risk

K081253 is an FDA 510(k) clearance for the ZIRDENT CAD/CAM BLOCKS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by C5 Medical Werks, Inc. (Grand Junction, US). The FDA issued a Cleared decision on May 15, 2008 after a review of 13 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.

FDA 510(k) Submission Details - K081253

510(k) Number K081253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2008
Decision Date May 15, 2008
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 128d · This submission: 13d
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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EIH Powder, Porcelain

All 479
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K081253.
VINTAGE ART
K080834 · Shofu Dental Corp. · Jun 2008
ZIRKONDENT
K080146 · Ergometa · Jun 2008
DENTAL CERAMIC
K080479 · Dmg USA, Inc. · May 2008
NACERA Z AND NACERA Z MEDIUM
K080195 · Doceram Medical Ceramics GmbH · Apr 2008
HEANY INDUSTRIES INC DENTAL XIRCONIA
K073314 · Heany Industries, Inc. · Feb 2008
PSL BIOZIR BLOCK
K073568 · P.S.L. International, Inc. · Feb 2008
K081253 · ZIRDENT CAD/CAM BLOCKS
Download PDF FDA Summary C5 Medical Werks, Inc.