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 |