The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer Liquid.
| Device ID | K131068 |
| 510k Number | K131068 |
| Device Name: | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID |
| Classification | Liner, Cavity, Calcium Hydroxide |
| 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 | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-17 |
| Decision Date | 2013-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR001217KA1 | K131068 | 000 |
| EKUR001216KA1 | K131068 | 000 |
| EKUR001215KA1 | K131068 | 000 |
| EKUR001210KA1 | K131068 | 000 |