The following data is part of a premarket notification filed by Spident Co., Ltd. with the FDA for Es Bond.
Device ID | K120767 |
510k Number | K120767 |
Device Name: | ES BOND |
Classification | Agent, Tooth Bonding, Resin |
Applicant | SPIDENT CO., LTD. 312, 151B-6L NAMDONGGONGDAN Incheon, KR 405-821 |
Contact | I.s. Whang |
Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-03-14 |
Decision Date | 2012-05-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08809262955415 | K120767 | 000 |