Cleared Traditional

K262559 - Mouth Guard

K262559 · ChangSha ChuangDuoLe E-Commerce Co., Ltd. · Dental device
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Sep 2026
Decision
54d
Days
-
Risk

K262559 is an FDA 510(k) clearance for the Mouth Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by ChangSha ChuangDuoLe E-Commerce Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on September 16, 2026 after a review of 54 days - a notably fast clearance cycle.

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: 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 ChangSha ChuangDuoLe E-Commerce Co., Ltd. devices

FDA 510(k) Submission Details - K262559

510(k) Number K262559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2026
Decision Date September 16, 2026
Days to Decision 54 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
74d faster than avg
Panel avg: 128d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

OBR Device Classification - Class 0,

Product Code OBR Mouthguard, Over-the-counter
Device Class -
Definition To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.

Regulatory Consultant

Shanghai Sungo Management Consulting Co., Ltd.
Ivy 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 - OBR Mouthguard, Over-the-counter

All 46
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K262559.
G-Series Grind Guard
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ClenchNoMore (CNM-1 (Mixed sizing))
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Owl Night Guard
K253641 · Owl Dental Lab, Inc. · Feb 2026
enCore Night Guard
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Remi Custom Night Guard
K251778 · Remi · Oct 2025
Dentemp Pro-Comfort Dental Guard
K250456 · Doc Brands, Inc. · May 2025