Cleared Traditional

K030588 - ARTEGRAL AND POLYSTAR SELECTION

K030588 is an FDA 510(k) clearance for ARTEGRAL AND POLYSTAR SELECTION, manufactured by Merz Dental GmbH. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K030588 · Merz Dental GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
71d
Days
Class 2
Risk

K030588 is an FDA 510(k) clearance for the ARTEGRAL AND POLYSTAR SELECTION. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Merz Dental GmbH (Concord, US). The FDA issued a Cleared decision on May 7, 2003 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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 Merz Dental GmbH devices

FDA 510(k) Submission Details - K030588

510(k) Number K030588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2003
Decision Date May 07, 2003
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELM Device Classification - Class 2, Special Controls

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
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 - ELM Denture, Plastic, Teeth

All 19
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K030588.
MONDIAL
K060994 · Heraeus Kulzer, Inc. · May 2006
CONDYLAFORM II NFC
K060565 · Ivoclar Vivadent, Inc. · May 2006
ARTIC
K033628 · Heraeus Kulzer, Inc. · Jan 2004
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
K023035 · Ivoclar Vivadent, Inc. · Dec 2002
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
K962456 · Ivoclar North America, Inc. · Aug 1996