Identifiers
- 510(k) Number
- K162598 FDA 510(k)
- FDA Product Code
- EBC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3765 FDA 510(k)
- Regulation Number
- 872.3765 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hapi Seal is a sealant, pit and fissure, and conditioner, classified as a Class 2 medical device. It is used in dental applications.
The Hapi Seal is supplied by Bisco, Inc. and has received FDA 510(k) clearance, with the clearance number K162598. The device has undergone biocompatibility evaluation, including cytotoxicity and oral toxicity testing, and has been found to be non-toxic. The Hapi Seal is regulated under the regulation number 872.3765.
Frequently asked questions
What is the Hapi Seal used for?
The Hapi Seal is used in dental applications as a sealant, pit and fissure, and conditioner.
Is the Hapi Seal toxic?
No, the Hapi Seal has undergone biocompatibility evaluation, including cytotoxicity and oral toxicity testing, and has been found to be non-toxic.
What regulatory clearance has the Hapi Seal received?
The Hapi Seal has received FDA 510(k) clearance, with the clearance number K162598, and is regulated under the regulation number 872.3765.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HAPI Seal (K162598) — FDA 510(k) | Innolitics, PDF Bisco, Inc. May 23, 2017 Ryan Hobson Regulatory Affairs Product ..., HAPI Seal — FDA 510 (k) K162598 | MedTracker - aiqixie.com, HAPI Seal - FDA 510 (k) K162598 | Pure Global AI
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162598 | Class II | Active |
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Manufacturer
- Manufacturer
- Bisco Inc.
- FDA Applicant
- Bisco, Inc.
Sources (1)
- FDA 510(k) K162598 24 fields · synced Sep 22, 2026