Cleared Special

K052710 - VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX

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

K052710 is an FDA 510(k) clearance for VITA VM7, manufactured by Vident. The device is a Class 2 Dental device with product code EIH cleared through the Special 510(k) pathway after a 106-day FDA review.

K052710 · Vident · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K052710

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 128d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

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 487
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K052710.
PRISMATIK CLINICAL ZIRCONIA
K060104 · Glidewell Laboratories · Mar 2006
FENIIIIIIX COLORATION KIT
K060086 · Dental Arte, Inc. · Mar 2006
GLASS CERAMICS
K053438 · 3M Espe AG Dental Products · Jan 2006
SUPER PORCELAIN EX-3 PRESS
K052304 · Noritake Co., Inc. · Nov 2005
VINTAGE ZR
K052033 · Shofu Dental Corp. · Nov 2005
HERACERAM ZIRKONIA
K052543 · Heraeus Kulzer, Inc. · Oct 2005
K052710 · VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX
Download PDF FDA Summary Vident