HAPI Seal
FDA 510(k) K162598 · Bisco, Inc.
510(k) numberK162598
Submission
- Device name
- HAPI Seal
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- September 19, 2016
- Decision date
- May 23, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBC
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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 |
| K161580 | Premier SealantEBC · Traditional | Premier Dental Company Products | 10/18/2016SE |
| K141717 | Pacseal Pit & Fissure SealantEBC · Traditional | Pac-Dent International, Inc. | 03/09/2015SE |
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| K192007 | TheraBase, TheraBase CaEMA · Traditional | 03/17/2020SE |
| K182917 | FluoroCalLBH · Traditional | 11/18/2019SE |
| K180344 | TheraCal DCEJK · Special | 04/05/2018SE |
| K171147 | REVEAL BulkEBF · Traditional | 08/04/2017SE |
| K163171 | CeraCleanPME · Traditional | 04/14/2017SE |
| K161051 | All-Bond Universal w/BAC (not finalized)KLE · Traditional | 09/09/2016SE |
| K161256 | TheraCemEMA · Traditional | 07/29/2016SE |
| K143292 | TheraCal DCEJK · Traditional | 08/04/2015SE |
Questions and answers
When was HAPI Seal cleared by the FDA?
HAPI Seal (K162598) received a 510(k) decision of Substantially Equivalent on May 23, 2017, 246 days after the submission was received.
What is the product code of K162598?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.