The following data is part of a premarket notification filed by Essential Dental Systems with the FDA for Eds Bioceramic Sealer (bioseal).
| Device ID | K202281 |
| 510k Number | K202281 |
| Device Name: | EDS Bioceramic Sealer (Bioseal) |
| Classification | Resin, Root Canal Filling |
| Applicant | Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606 |
| Contact | Jason Guzman |
| Correspondent | Jason Guzman Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-12 |
| Decision Date | 2021-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766054002949 | K202281 | 000 |