Cleared Traditional

K180803 - BeautiBond Universal

K180803 is an FDA 510(k) clearance for BeautiBond Universal, manufactured by Shofu Dental Corporation. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K180803 · Shofu Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
182d
Days
Class 2
Risk

K180803 is an FDA 510(k) clearance for the BeautiBond Universal. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on September 26, 2018 after a review of 182 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Shofu Dental Corporation devices

FDA 510(k) Submission Details - K180803

510(k) Number K180803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2018
Decision Date September 26, 2018
Days to Decision 182 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
55d slower than avg
Panel avg: 127d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 335
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K180803.
OptiBond eXTRa Universal
K182162 · Kerr Corporation · Nov 2018
BracePaste MTP Light Cure Primer
K181910 · American Orthodontics · Oct 2018
Prime&Bond active Universal Adhesive
K181476 · Dentsply Sirona · Sep 2018
Meta P&Bond
K180802 · Meta Biomed Co., Ltd. · Aug 2018
Acid Etchant
K172953 · American Orthodontics · Feb 2018
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
K172977 · Nanova Biomaterials, Inc. · Jan 2018