The following data is part of a premarket notification filed by Germiphene Corp. with the FDA for Smile Integrated Prophylaxis Paste Rings.
Device ID | K942851 |
510k Number | K942851 |
Device Name: | SMILE INTEGRATED PROPHYLAXIS PASTE RINGS |
Classification | Agent, Polishing, Abrasive, Oral Cavity |
Applicant | GERMIPHENE CORP. 6839 MONTEVIDEO ROAD MISSISSAUGA, ONTARIO L5n 1n7, CA L5n 1n7 |
Contact | Janet Shaw |
Correspondent | Janet Shaw GERMIPHENE CORP. 6839 MONTEVIDEO ROAD MISSISSAUGA, ONTARIO L5n 1n7, CA L5n 1n7 |
Product Code | EJR |
CFR Regulation Number | 872.6030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-16 |
Decision Date | 1994-11-04 |