Device Classification Name |
mouthguard, prescription
|
510(k) Number |
K211415 |
Device Name |
GR Splint Resin System |
Applicant |
Pro3dure Medical GmbH |
Am Burgberg 13 |
Iserlohn,
DE
58642
|
|
Applicant Contact |
Frank Gischer |
Correspondent |
Regulatory and Quality Solutions, LLC |
2790 Mosside Blvd. |
Monroeville,
PA
15146
|
|
Correspondent Contact |
Patricia Kontoudis |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/06/2021 |
Decision Date | 10/21/2021 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|