The following data is part of a premarket notification filed by Roeko Ulm, Roescheisen Gmbh & Co. with the FDA for Roeko Seal.
| Device ID | K983037 |
| 510k Number | K983037 |
| Device Name: | ROEKO SEAL |
| Classification | Resin, Root Canal Filling |
| Applicant | ROEKO ULM, ROESCHEISEN GMBH & CO. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Contact | James Delaney |
| Correspondent | James Delaney ROEKO ULM, ROESCHEISEN GMBH & CO. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-31 |
| Decision Date | 1998-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E16555430 | K983037 | 000 |
| E1653491030 | K983037 | 000 |
| E1653491020 | K983037 | 000 |
| E1653491000 | K983037 | 000 |