Cleared Traditional

K233161 - BeautiLink SA (FDA 510(k) Clearance)

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

K233161 · Shofu Dental Corporation · Dental device
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Sep 2023
Decision
1d
Days
Class 2
Risk

K233161 is an FDA 510(k) clearance for the BeautiLink SA. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on September 28, 2023 after a review of 1 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shofu Dental Corporation devices

Submission Details

510(k) Number K233161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2023
Decision Date September 28, 2023
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 127d · This submission: 1d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

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 - EMA Cement, Dental

All 503
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