The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Ultra Ii Porcelain Polishing Paste.
| Device ID | K896071 |
| 510k Number | K896071 |
| Device Name: | ULTRA II PORCELAIN POLISHING PASTE |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Martin J Dymek |
| Correspondent | Martin J Dymek SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-19 |
| Decision Date | 1990-08-14 |