Cleared Traditional

Visalys CemCore, Visalys Cem Core Try In Paste (K191527) - FDA 510(k) Clearance

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

K191527 · Kettenbach GmbH & Co. KG · Dental device
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Nov 2019
Decision
151d
Days
Class 2
Risk

K191527 is an FDA 510(k) clearance for the Visalys CemCore, Visalys Cem Core Try In Paste. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Kettenbach GmbH & Co. KG (Eschenburg, DE). The FDA issued a Cleared decision on November 8, 2019 after a review of 151 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Kettenbach GmbH & Co. KG devices

Submission Details

510(k) Number K191527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2019
Decision Date November 08, 2019
Days to Decision 151 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 127d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 136
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