The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Crystar(tm) Anti-greening Liquid.
| Device ID | K893481 |
| 510k Number | K893481 |
| Device Name: | CRYSTAR(TM) ANTI-GREENING LIQUID |
| Classification | Teeth, Porcelain |
| 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 | ELL |
| CFR Regulation Number | 872.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-04 |
| Decision Date | 1989-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23565070 | K893481 | 000 |
| E23565050 | K893481 | 000 |