Cleared Traditional

K230592 - LuxCreo Dental Night Guard Resin

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

FDA 510(k) Submission Details - K230592

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.

MQC Device Classification - Class 0,

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.

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All 42
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