Cleared Traditional

K093331 - SR PHONARES NHC

K093331 is the FDA 510(k) clearance for SR PHONARES NHC by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code ELM) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K093331 · Ivoclar Vivadent, Inc. · Dental device
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Jan 2010
Decision
94d
Days
Class 2
Risk

K093331 is an FDA 510(k) clearance for the SR PHONARES NHC. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on January 28, 2010 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K093331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2009
Decision Date January 28, 2010
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K093331.
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984 · Ivoclar Vivadent, Inc. · Jan 2014
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