The following data is part of a premarket notification filed by Spident Co., Ltd. with the FDA for Estemp Implant, Estemp Clear.
| Device ID | K134021 |
| 510k Number | K134021 |
| Device Name: | ESTEMP IMPLANT, ESTEMP CLEAR |
| Classification | Cement, Dental |
| Applicant | SPIDENT CO., LTD. 2115 LINWOOD AVE 5TH FLOOR Fort Lee, NJ 07024 |
| Contact | Lena Pak |
| Correspondent | Lena Pak SPIDENT CO., LTD. 2115 LINWOOD AVE 5TH FLOOR Fort Lee, NJ 07024 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-30 |
| Decision Date | 2014-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20200623170096 | K134021 | 000 |