Cleared Traditional

K230592 - LuxCreo Dental Night Guard Resin (FDA 510(k) Clearance)

K230592 · LuxCreo, Inc. · Dental device
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Jan 2024
Decision
321d
Days
-
Risk

K230592 is an FDA 510(k) clearance for the LuxCreo Dental Night Guard Resin. Classified as Mouthguard, Prescription (product code MQC).

Submitted by LuxCreo, Inc. (Belmont, US). The FDA issued a Cleared decision on January 18, 2024 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel. 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. Elevated predicate reliance profile. 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 LuxCreo, Inc. devices

Submission Details

510(k) Number K230592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2023
Decision Date January 18, 2024
Days to Decision 321 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
194d slower than avg
Panel avg: 127d · This submission: 321d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Consultant

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Reanny Wang

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 - MQC Mouthguard, Prescription

All 70
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