Cleared Traditional

Thermoforming Sheet Materials (Track A) (K241311) - FDA 510(k) Clearance

Also marketed or referenced as:
Thermoforming Sheet Materials (Track B) Thermoforming Sheet Materials (Track E) Thermoforming Sheet Materials (Track Bleach)
K241311 · Bernhard F?rster GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
85d
Days
-
Risk

K241311 is an FDA 510(k) clearance for the Thermoforming Sheet Materials (Track A). Classified as Mouthguard, Prescription (product code MQC).

Submitted by Bernhard F?rster GmbH (Pforzheim, DE). The FDA issued a Cleared decision on August 2, 2024 after a review of 85 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 Bernhard F?rster GmbH devices

Submission Details

510(k) Number K241311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2024
Decision Date August 02, 2024
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 40
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K241311.
Remi Custom Night Guard
K243516 · Grindguard, Inc. · Feb 2025
LIJIA Night Guard
K241369 · Lijia, LLC · Aug 2024
GR Resin System MSI
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Slow Wave DS8 (SWDS802)
K240463 · Slow Wave, Inc. · Jun 2024
RODIN 3D Resin SPLINT, Hard/Flex
K231793 · Belport Company, Inc., Gingi-Pak · Mar 2024
Dental LT Comfort Resin
K232087 · Formlabs Ohio, Inc. · Feb 2024