Cleared Traditional

Papacarie Duo (K233768) - FDA 510(k) Clearance

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

K233768 · Elevate Oral Care · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
237d
Days
Class 2
Risk

K233768 is an FDA 510(k) clearance for the Papacarie Duo. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Elevate Oral Care (West Palm Beach, US). The FDA issued a Cleared decision on July 18, 2024 after a review of 237 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 Elevate Oral Care devices

Submission Details

510(k) Number K233768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2023
Decision Date July 18, 2024
Days to Decision 237 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
110d slower than avg
Panel avg: 127d · This submission: 237d
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 Peers - LBH Varnish, Cavity

All 32
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K233768.
ReminGel
K241489 · Inter-Med, Inc. · Jan 2025
CrystLCare™ PRO Biorestorative, Fluoride-Plus
K241568 · GreenMark Biomedical, Inc. · Jan 2025
Jasmate® Toothpaste
K242913 · Jasberry Healthcare Private Limited · Nov 2024
ProMin Dental Desensitizing Gel
K231060 · Belport Company, Inc., Gingi-Pak · Jun 2024
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
K230333 · Kettenbach GmbH & Co. KG · Jul 2023
Dental Desensitizer
K222891 · Guangzhou Beogene Biotech Co., Ltd. · May 2023