Cleared Traditional

K060441 - VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX

Also marketed or referenced as:
VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX VITA VM 9, MODEL NX98

K060441 is an FDA 510(k) clearance for VITA VM 7, manufactured by Vident. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K060441 · Vident · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
65d
Days
Class 2
Risk

K060441 is an FDA 510(k) clearance for the VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vident (Brea, US). The FDA issued a Cleared decision on April 27, 2006 after a review of 65 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.

View all Vident devices

FDA 510(k) Submission Details - K060441

510(k) Number K060441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2006
Decision Date April 27, 2006
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - EIH Powder, Porcelain

All 400
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K060441.
CARRARA VOLUMIA
K070019 · Dentsply Intl. · Jan 2007
INCORIS ZI
K062509 · Sirona Dental Systems GmbH · Sep 2006
INCORIS AL
K062506 · Sirona Dental Systems GmbH · Sep 2006
GLASS CERAMICS
K053438 · 3M Espe AG Dental Products · Jan 2006
VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX
K052710 · Vident · Jan 2006
VINTAGE ZR
K052033 · Shofu Dental Corp. · Nov 2005