Cleared Special

VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX (K052710) - FDA 510(k) Clearance

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

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052710 · Vident · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
106d
Days
Class 2
Risk

K052710 is an FDA 510(k) clearance for the VITA VM7, 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 January 13, 2006 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vident devices

Submission Details

510(k) Number K052710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date January 13, 2006
Days to Decision 106 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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