The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Protemp Cement Temporary Dental Cement.
Device ID | K170330 |
510k Number | K170330 |
Device Name: | 3M Protemp Cement Temporary Dental Cement |
Classification | Cement, Dental |
Applicant | 3M Company 2510 Conway Avenue St. Paul, MN 55144 -1000 |
Contact | Gretchen Keenan |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2017-02-02 |
Decision Date | 2017-02-06 |
Summary: | summary |