Cleared Traditional

K200125 - Thermoforming Sheet Materials

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

FDA 510(k) Submission Details - K200125

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.

MQC Device Classification - Class 0,

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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All 56
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