The following data is part of a premarket notification filed by Discus Dental Inc. with the FDA for Splash! Impression Material Device.
| Device ID | K052090 |
| 510k Number | K052090 |
| Device Name: | SPLASH! IMPRESSION MATERIAL DEVICE |
| Classification | Material, Impression |
| Applicant | DISCUS DENTAL INC. 8550 HIGUERA ST. Culver City, CA 90232 |
| Contact | Suzanne Ridgway |
| Correspondent | Alfredo J Quattrone CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 997 413 FDB MAILSTOP 7602 Sacramento, CA 95899 -7413 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-02 |
| Decision Date | 2005-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813SPD12080 | K052090 | 000 |
| D813SPD15300 | K052090 | 000 |
| D813SPD15310 | K052090 | 000 |
| D813SPD15320 | K052090 | 000 |
| D813SPD15590 | K052090 | 000 |
| D813SPD15600 | K052090 | 000 |
| D813SPD15871 | K052090 | 000 |
| D813SPD15881 | K052090 | 000 |
| D813SPD15891 | K052090 | 000 |
| D813SPD15901 | K052090 | 000 |
| D813SPD15911 | K052090 | 000 |
| D813SPD15921 | K052090 | 000 |
| D813SPD15290 | K052090 | 000 |
| D813SPD13501 | K052090 | 000 |
| D813SPD12501 | K052090 | 000 |
| D813SPD12090 | K052090 | 000 |
| D813SPD12100 | K052090 | 000 |
| D813SPD12110 | K052090 | 000 |
| D813SPD12120 | K052090 | 000 |
| D813SPD12190 | K052090 | 000 |
| D813SPD12300 | K052090 | 000 |
| D813SPD12310 | K052090 | 000 |
| D813SPD12320 | K052090 | 000 |
| D813SPD12330 | K052090 | 000 |
| D813SPD12350 | K052090 | 000 |
| D813SPD12371 | K052090 | 000 |
| D813SPD15931 | K052090 | 000 |
| D813SPD15941 | K052090 | 000 |
| D813SPD16000 | K052090 | 000 |
| D813SPD16151 | K052090 | 000 |
| D813SPD16161 | K052090 | 000 |
| D813SPD16171 | K052090 | 000 |
| D813SPD19000 | K052090 | 000 |
| D813SPD19010 | K052090 | 000 |
| D813SPD19020 | K052090 | 000 |
| D813SPD19030 | K052090 | 000 |
| D813SPD19040 | K052090 | 000 |
| D813SPD19050 | K052090 | 000 |
| D813SPD19060 | K052090 | 000 |
| D813SPD19070 | K052090 | 000 |
| D813SPD16141 | K052090 | 000 |
| D813SPD16131 | K052090 | 000 |
| D813SPD16121 | K052090 | 000 |
| D813SPD16010 | K052090 | 000 |
| D813SPD16021 | K052090 | 000 |
| D813SPD16031 | K052090 | 000 |
| D813SPD16041 | K052090 | 000 |
| D813SPD16051 | K052090 | 000 |
| D813SPD16061 | K052090 | 000 |
| D813SPD16071 | K052090 | 000 |
| D813SPD16081 | K052090 | 000 |
| D813SPD16091 | K052090 | 000 |
| D813SPD16101 | K052090 | 000 |
| D813SPD16111 | K052090 | 000 |
| D813SPD19080 | K052090 | 000 |