Cleared Traditional

K191453 - Cervitec F

K191453 is the FDA 510(k) clearance for Cervitec F by Ivoclar Vivadent, AG. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K191453 · Ivoclar Vivadent, AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
256d
Days
Class 2
Risk

K191453 is an FDA 510(k) clearance for the Cervitec F. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on February 11, 2020 after a review of 256 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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 Ivoclar Vivadent, AG devices

Submission Details

510(k) Number K191453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2019
Decision Date February 11, 2020
Days to Decision 256 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
129d slower than avg
Panel avg: 127d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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

Ivoclar Vivadent, Inc.
Lori Aleshin

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 - LBH Varnish, Cavity

All 70
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K191453.
BioMin Restore Plus
K200077 · Dr. Collins, Inc. · Nov 2020
FiteBac Antimicrobial Cavity Cleanser
K200614 · Largent Health, LLC · Jun 2020
DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
K192381 · Scientific Pharmaceuticals · Feb 2020
FiteBac Cavity Cleanser
K190271 · Largent Health, LLC · Jan 2020
FluoroCal
K182917 · Bisco, Inc. · Nov 2019
Restore Toothpaste
K181965 · Dr. Collins, Inc. · Jun 2019