Cleared Traditional

Thermoforming Sheet Materials (K200125) - FDA 510(k) Clearance

K200125 · Erkodent Erich Kopp GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
281d
Days
-
Risk

K200125 is an FDA 510(k) clearance for the Thermoforming Sheet Materials. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Erkodent Erich Kopp GmbH (Pfalzgrafenweiler, DE). The FDA issued a Cleared decision on October 28, 2020 after a review of 281 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Erkodent Erich Kopp GmbH devices

Submission Details

510(k) Number K200125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2020
Decision Date October 28, 2020
Days to Decision 281 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
154d slower than avg
Panel avg: 127d · This submission: 281d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Consultant

Ajw Technology Consultants, Inc.
Jon Ward

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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