Cleared Traditional

K210115 - FiteBac CC OrthoSeal (FDA 510(k) Clearance)

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

K210115 · Largent Health, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Jul 2021
Decision
191d
Days
Class 2
Risk

K210115 is an FDA 510(k) clearance for the FiteBac CC OrthoSeal. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Largent Health, LLC (Marietta, US). The FDA issued a Cleared decision on July 29, 2021 after a review of 191 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 Largent Health, LLC devices

Submission Details

510(k) Number K210115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2021
Decision Date July 29, 2021
Days to Decision 191 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
64d slower than avg
Panel avg: 127d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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

Secure BioMed Evaluations
Elizabeth O’Keeffe

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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 191
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