The following data is part of a premarket notification filed by Ortho Source with the FDA for Orthosource Etch Systems.
| Device ID | K861245 |
| 510k Number | K861245 |
| Device Name: | ORTHOSOURCE ETCH SYSTEMS |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood, CA 91607 |
| Contact | Lloyd R Taylor |
| Correspondent | Lloyd R Taylor ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood, CA 91607 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-02 |
| Decision Date | 1986-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D9115574670 | K861245 | 000 |
| D911557424K1 | K861245 | 000 |
| D911557422K1 | K861245 | 000 |
| D9115574190 | K861245 | 000 |
| D9115574180 | K861245 | 000 |
| D9115574150 | K861245 | 000 |
| D911557618C251 | K861245 | 000 |
| D911557617C251 | K861245 | 000 |
| D911557418C251 | K861245 | 000 |
| D911557466601 | K861245 | 000 |
| D911557468601 | K861245 | 000 |
| D911557041503 | K861245 | 000 |
| D911557040503 | K861245 | 000 |
| D9115576190 | K861245 | 000 |
| D9115576180 | K861245 | 000 |
| D9115576170 | K861245 | 000 |
| D9115576150 | K861245 | 000 |
| D9115575190 | K861245 | 000 |
| D9115575150 | K861245 | 000 |
| D9115574120 | K861245 | 000 |