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 |