The following data is part of a premarket notification filed by Pacific Union Dental, Inc. with the FDA for Root Canal Organizer.
| Device ID | K860817 |
| 510k Number | K860817 |
| Device Name: | ROOT CANAL ORGANIZER |
| Classification | Carver, Wax, Dental |
| Applicant | PACIFIC UNION DENTAL, INC. P.O. BOX 2025 Silver Spring, MD 20902 |
| Contact | Woo, Pres. |
| Correspondent | Woo, Pres. PACIFIC UNION DENTAL, INC. P.O. BOX 2025 Silver Spring, MD 20902 |
| Product Code | EIK |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-03-17 |