Cleared Traditional

K161734 - Vanguard Dental Unit

K161734 is an FDA 510(k) clearance for Vanguard Dental Unit, manufactured by Ritter Concept GmbH. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K161734 · Ritter Concept GmbH · Dental device
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Dec 2016
Decision
169d
Days
Class 1
Risk

K161734 is an FDA 510(k) clearance for the Vanguard Dental Unit. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Ritter Concept GmbH (Zwonitz, DE). The FDA issued a Cleared decision on December 9, 2016 after a review of 169 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K161734

510(k) Number K161734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2016
Decision Date December 09, 2016
Days to Decision 169 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
41d slower than avg
Panel avg: 128d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Licensale, Inc.
RAYMOND KELLY

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.

Regulatory Peers - EIA Unit, Operative Dental

All 239
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