Apco Fissure Sealer & Bonding Agent
FDA 510(k) K843098 · Scientific Pharmaceuticals, Inc.
510(k) numberK843098
Submission
- Device name
- Apco Fissure Sealer & Bonding Agent
- Applicant
- Scientific Pharmaceuticals, Inc.
Walker, MI, US - Received
- August 7, 1984
- Decision date
- September 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| 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 |
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| K013555 | Sci-Pharm Post SecureEMA · Traditional | 01/23/2002SE |
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| K982915 | Sci-Pharm DFV VarnishLBH · Traditional | 02/12/1999SE |
| K983305 | Sci-Pharm Desensitizing VarnishLBH · Traditional | 12/17/1998SE |
| K982913 | Zinfos Zinc Phosphate CementEMA · Traditional | 10/19/1998SE |
| K944466 | SealdentEBI · Traditional | 03/02/1995SE |
Questions and answers
When was Apco Fissure Sealer & Bonding Agent cleared by the FDA?
Apco Fissure Sealer & Bonding Agent (K843098) received a 510(k) decision of Substantially Equivalent on September 7, 1984, 31 days after the submission was received.
What is the product code of K843098?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.