Cleared Traditional

K193553 - VarseoSmile Temp

K193553 is the FDA 510(k) clearance for VarseoSmile Temp by Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K193553 · Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
150d
Days
Class 2
Risk

K193553 is an FDA 510(k) clearance for the VarseoSmile Temp. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG (Bremen, DE). The FDA issued a Cleared decision on May 18, 2020 after a review of 150 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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.

View all Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG devices

Submission Details

510(k) Number K193553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date May 18, 2020
Days to Decision 150 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
23d slower than avg
Panel avg: 127d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 91
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