Cleared Traditional

VarseoSmile Crown plus (K201668) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201668 · Bego Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KG · Dental device
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Jun 2020
Decision
4d
Days
Class 2
Risk

K201668 is an FDA 510(k) clearance for the VarseoSmile Crown plus. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bego Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KG (Bremen, DE). The FDA issued a Cleared decision on June 23, 2020 after a review of 4 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bego Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KG devices

Submission Details

510(k) Number K201668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2020
Decision Date June 23, 2020
Days to Decision 4 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 127d · This submission: 4d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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

Regulatory Technology Services, LLC
Prithul Bom

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 - EBF Material, Tooth Shade, Resin

All 291
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