The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Hybrid Points.
| Device ID | K854347 |
| 510k Number | K854347 |
| Device Name: | HYBRID POINTS |
| Classification | Instrument, Diamond, Dental |
| Applicant | SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Marty Dymek |
| Correspondent | Marty Dymek SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Product Code | DZP |
| CFR Regulation Number | 872.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-29 |
| Decision Date | 1985-12-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HYBRID POINTS 78641359 3095471 Live/Registered |
Shofu, Inc. 2005-06-01 |
![]() HYBRID POINTS 76545336 not registered Dead/Abandoned |
SHOFU, INC. 2003-09-04 |
![]() HYBRID POINTS 74185103 1752367 Dead/Cancelled |
SHOFU INC. 1991-07-15 |
![]() HYBRID POINTS 73586257 not registered Dead/Abandoned |
SHOFU DENTAL CORPORATION 1986-03-05 |