The following data is part of a premarket notification filed by Sci-pharm, Inc. with the FDA for Fissure Sealer & Bonding Agent.
| Device ID | K813091 |
| 510k Number | K813091 |
| Device Name: | FISSURE SEALER & BONDING AGENT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | SCI-PHARM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-02 |
| Decision Date | 1981-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP5601S1 | K813091 | 000 |
| D801SP5601CH1 | K813091 | 000 |
| D801SP56011N1 | K813091 | 000 |
| D801SP56011B1 | K813091 | 000 |
| D801SP56011 | K813091 | 000 |