Cleared Abbreviated

K102128 - VITABLOCS

K102128 is an FDA 510(k) clearance for VITABLOCS, manufactured by Vita Zahnfabrik H.Rauter GmbH & Co.. The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 13-day FDA review.

K102128 · Vita Zahnfabrik H.Rauter GmbH & Co. · Dental device
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Aug 2010
Decision
13d
Days
Class 2
Risk

K102128 is an FDA 510(k) clearance for the VITABLOCS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vita Zahnfabrik H.Rauter GmbH & Co. (Brea, US). The FDA issued a Cleared decision on August 11, 2010 after a review of 13 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vita Zahnfabrik H.Rauter GmbH & Co. devices

FDA 510(k) Submission Details - K102128

510(k) Number K102128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2010
Decision Date August 11, 2010
Days to Decision 13 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 128d · This submission: 13d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 469
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