Device Classification Name |
cement, dental
|
510(k) Number |
K192992 |
Device Name |
Suglue 3 |
Applicant |
3M Deutschland GMBH |
ESPE Platz, Seefeld |
Bavaria,
DE
82229
|
|
Applicant Contact |
Desi W. Soegiarto |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 872.3275
|
Classification Product Code |
|
Date Received | 10/25/2019 |
Decision Date | 11/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|