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 |