Cleared Traditional

K060565 - CONDYLAFORM II NFC

K060565 is the FDA 510(k) clearance for CONDYLAFORM II NFC by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code ELM) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K060565 · Ivoclar Vivadent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
66d
Days
Class 2
Risk

K060565 is an FDA 510(k) clearance for the CONDYLAFORM II NFC. 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 May 8, 2006 after a review of 66 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 Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K060565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2006
Decision Date May 08, 2006
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
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 15
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K060565.
VERACIA SA
K113426 · Shofu Dental Corporation · Feb 2012
SR PHONARES NHC
K093331 · Ivoclar Vivadent, Inc. · Jan 2010
MONDIAL
K060994 · Heraeus Kulzer, 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