The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer Liquid.
| Device ID | K122421 |
| 510k Number | K122421 |
| Device Name: | TEETHMATE DESENSITZER 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 | 2012-08-09 |
| Decision Date | 2012-12-11 |
| Summary: | summary |