Cleared Special

K052130 - VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40

K052130 is an FDA 510(k) clearance for VITA IN-CERAM 2000 AL CUBES FOR INLAB, manufactured by Vident. The device is a Class 2 Dental device with product code EIH cleared through the Special 510(k) pathway after a 10-day FDA review.

K052130 · Vident · Dental device
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Aug 2005
Decision
10d
Days
Class 2
Risk

K052130 is an FDA 510(k) clearance for the VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vident (Brea, US). The FDA issued a Cleared decision on August 15, 2005 after a review of 10 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. 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. Low regulatory complexity profile. 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 - K052130

510(k) Number K052130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2005
Decision Date August 15, 2005
Days to Decision 10 days
Submission Type Special
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
118d faster than avg
Panel avg: 128d · This submission: 10d
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 K052130.
VINTAGE ZR
K052033 · Shofu Dental Corp. · Nov 2005
HERACERAM ZIRKONIA
K052543 · Heraeus Kulzer, Inc. · Oct 2005
IPS E.MAX CAD/IPS E.MAX ZIRCAD
K051705 · Ivoclar Vivadent, Inc. · Oct 2005
ZIROX
K051249 · Wieland Dental + Technik GmbH & Co. KG · Jul 2005
MODIFICATION TO: CERCON BASE
K051462 · Dentsply Intl. · Jun 2005
XAWEX G 100
K050903 · Wieland Dental + Technik GmbH & Co. KG · Jun 2005
K052130 · VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
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