Device Classification Name |
Mouthguard, Prescription
|
510(k) Number |
K200125 |
Device Name |
Thermoforming Sheet Materials |
Applicant |
Erkodent Erich Kopp GmbH |
Siemensstrasse 3 |
Pfalzgrafenweiler,
DE
72285
|
|
Applicant Contact |
Hans-Peter Kopp |
Correspondent |
AJW Technology Consultants, Inc. |
11705 Boyette Road, Suite 503 |
Riverview,
FL
33569
|
|
Correspondent Contact |
Jon Ward |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/21/2020 |
Decision Date | 10/28/2020 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|