RESICEM
Cement, Dental
SHOFU DENTAL CORP.
The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Resicem.
Pre-market Notification Details
| Device ID | K080517 |
| 510k Number | K080517 |
| Device Name: | RESICEM |
| Classification | Cement, Dental |
| Applicant | SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Contact | David P Morais |
| Correspondent | David P Morais SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-25 |
| Decision Date | 2008-06-11 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23532340 | K080517 | 000 |
| E23532320 | K080517 | 000 |
| E23532280 | K080517 | 000 |
| E23532270 | K080517 | 000 |
| E23532210 | K080517 | 000 |
| E23532200 | K080517 | 000 |
Trademark Results [RESICEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESICEM 77575783 3618927 Live/Registered |
Shofu, Inc. 2008-09-22 |
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