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 |