Fissure Sealer & Bonding Agent
FDA 510(k) K813091 · Sci-Pharm, Inc.
510(k) numberK813091
Submission
- Device name
- Fissure Sealer & Bonding Agent
- Applicant
- Sci-Pharm, Inc.
Mchenry, IL, US - Received
- November 2, 1981
- Decision date
- November 24, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260819 | Any-Com SealEBC · Traditional | Mediclus Co., Ltd. | 05/01/2026SE |
| K243254 | Parkell Pit and Fissure SealantEBC · Abbreviated | Parkell, Inc. | 08/08/2025SE |
| K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioEBC · Traditional | Ultradent Product, Inc. | 08/18/2023SE |
| K230455 | Enamel Coating ResinEBC · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 07/25/2023SE |
| K190998 | BA Pit & Fissure SealantEBC · Abbreviated | Apex Dental Materials, Inc. | 11/08/2019SE |
| K190339 | Helioseal F PlusEBC · Abbreviated | Ivoclar Vivadent, AG | 07/29/2019SE |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCPEBC · Traditional | Pulpdent Corporation | 01/05/2018SE |
| K171330 | Nanova SealantEBC · Traditional | Nanova Biomaterials, Inc. | 09/08/2017SE |
| K162598 | HAPI SealEBC · Traditional | Bisco, Inc. | 05/23/2017SE |
| K161580 | Premier SealantEBC · Traditional | Premier Dental Company Products | 10/18/2016SE |
More from Premier Dental Company Products
| 510(k) | Device | Decision |
|---|---|---|
| K823935 | Micro Join, Crown & Bridge AdhesiveEMA · Traditional | 02/07/1983SE |
| K820092 | Secure-On-TouchDYH · Traditional | 02/24/1982SE |
| K813090 | Composite Dental Restorative MaterialEBF · Traditional | 11/24/1981SE |
| K812550 | BeaucavLBH · Traditional | 09/25/1981SE |
| K812549 | BeausealEBC · Traditional | 09/25/1981SE |
| K812548 | CobeauLBH · Traditional | 09/25/1981SE |
| K812546 | BeaudentEBF · Traditional | 09/25/1981SE |
| K812545 | BeaufillEBF · Traditional | 09/25/1981SE |
| K812551 | BeaucorEBF · Traditional | 09/23/1981SE |
| K812547 | BeaubonDYH · Traditional | 09/23/1981SE |
Questions and answers
When was Fissure Sealer & Bonding Agent cleared by the FDA?
Fissure Sealer & Bonding Agent (K813091) received a 510(k) decision of Substantially Equivalent on November 24, 1981, 22 days after the submission was received.
What is the product code of K813091?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.