Cleared Traditional

K093331 - SR PHONARES NHC

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

K093331 · Ivoclar Vivadent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K093331

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.

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 27
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K093331.
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
K120404 · Merz Dental GmbH · May 2012
SR PHONARES II
K120736 · Ivoclar Vivadent, AG · May 2012
VERACIA SA
K113426 · Shofu Dental Corporation · Feb 2012
MONDIAL
K060994 · Heraeus Kulzer, Inc. · May 2006
CONDYLAFORM II NFC
K060565 · Ivoclar Vivadent, Inc. · May 2006
ARTIC
K033628 · Heraeus Kulzer, Inc. · Jan 2004