The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond.
| Device ID | K132450 |
| 510k Number | K132450 |
| Device Name: | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY NORITAKE DENTAL INC. OTE CENTER BLDG 7F 1-1-3, OTEMACHI Chiyoda-ku, JP 100-0004 |
| Contact | Michio Takigawa |
| Correspondent | Michio Takigawa KURARAY NORITAKE DENTAL INC. OTE CENTER BLDG 7F 1-1-3, OTEMACHI Chiyoda-ku, JP 100-0004 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-06 |
| Decision Date | 2013-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR003300KA1 | K132450 | 000 |
| EKUR003293KA1 | K132450 | 000 |
| EKUR003292KA1 | K132450 | 000 |
| EKUR003291KA1 | K132450 | 000 |