The following data is part of a premarket notification filed by San Diego Swiss Machining, Inc. with the FDA for Sapphire Plus Scaler Mod. 300114/plugger Mod. 300115/cutting Mod. 300116/spreader Mod. 300117 Tips.
| Device ID | K960889 |
| 510k Number | K960889 |
| Device Name: | SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS |
| Classification | Scaler, Ultrasonic |
| Applicant | SAN DIEGO SWISS MACHINING, INC. 8910 UNIVERSITY CENTER LN. SUITE 265 San Diego, CA 92122 -1085 |
| Contact | Alan Donald |
| Correspondent | Alan Donald SAN DIEGO SWISS MACHINING, INC. 8910 UNIVERSITY CENTER LN. SUITE 265 San Diego, CA 92122 -1085 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-04 |
| Decision Date | 1996-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D716PUWRENCH1 | K960889 | 000 |
| D716PULTRAHEX1 | K960889 | 000 |
| D716PUENDO81 | K960889 | 000 |
| D716PUENDO71 | K960889 | 000 |
| D716PUENDO681 | K960889 | 000 |
| D716PUENDO61 | K960889 | 000 |
| D716PUENDO51 | K960889 | 000 |
| D716PUENDO41 | K960889 | 000 |
| D716PUENDO31 | K960889 | 000 |
| D716PUENDO21 | K960889 | 000 |
| D716PUENDO151 | K960889 | 000 |
| D716PUENDO11 | K960889 | 000 |
| D716PIEZOFLOWSOLO1 | K960889 | 000 |
| D716PIEZOFLOWREFILL0 | K960889 | 000 |
| D716PULTRAPZ1 | K960889 | 000 |
| D716PUSINE11 | K960889 | 000 |
| D716PUSINE161 | K960889 | 000 |
| D716PUWRENCH011 | K960889 | 000 |
| D716PUSURG61 | K960889 | 000 |
| D716PUSURG51 | K960889 | 000 |
| D716PUSURG41 | K960889 | 000 |
| D716PUSURG31 | K960889 | 000 |
| D716PUSURG21 | K960889 | 000 |
| D716PUSURG161 | K960889 | 000 |
| D716PUSURG11 | K960889 | 000 |
| D716PUSINE61 | K960889 | 000 |
| D716PUSINE51 | K960889 | 000 |
| D716PUSINE41 | K960889 | 000 |
| D716PUSINE31 | K960889 | 000 |
| D716PUSINE21 | K960889 | 000 |
| D716PIEZOFLOWAP1 | K960889 | 000 |