The following data is part of a premarket notification filed by Solar Dental Co., Inc. with the FDA for Hydron Root Canal Filling & Mark Iv Starter Kit.
| Device ID | K861846 |
| 510k Number | K861846 |
| Device Name: | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT |
| Classification | Syringe, Periodontic, Endodontic, Irrigating |
| Applicant | SOLAR DENTAL CO., INC. 111 N. WABASH Chicago, IL 60602 |
| Contact | Bauer, Phd |
| Correspondent | Bauer, Phd SOLAR DENTAL CO., INC. 111 N. WABASH Chicago, IL 60602 |
| Product Code | EIC |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-13 |
| Decision Date | 1986-06-26 |