Thermoforming Sheet Materials

Mouthguard, Prescription

Erkodent Erich Kopp GmbH

The following data is part of a premarket notification filed by Erkodent Erich Kopp Gmbh with the FDA for Thermoforming Sheet Materials.

Pre-market Notification Details

Device IDK200125
510k NumberK200125
Device Name:Thermoforming Sheet Materials
ClassificationMouthguard, Prescription
Applicant Erkodent Erich Kopp GmbH Siemensstrasse 3 Pfalzgrafenweiler,  DE 72285
ContactHans-peter Kopp
CorrespondentJon Ward
AJW Technology Consultants, Inc. 11705 Boyette Road, Suite 503 Riverview,  FL  33569
Product CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-21
Decision Date2020-10-28

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