Prevent Seal
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- PREVENT SEAL EUDAMED
- Device Name
- Fissure Sealant EUDAMED
- Model / Reference
- PVSEAL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760260221306 EUDAMED
- Basic UDI-DI
- B-03760260221306 EUDAMED
- 510(k) Number
- K122521 FDA 510(k)
- FDA Product Code
- EBC FDA 510(k)
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3765 FDA 510(k)
- Regulation Number
- 872.3765 FDA 510(k)
- Market of Registration
- France EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Prevent Seal is a Pit and Fissure Sealant, a dental adhesive designed to prevent tooth decay by sealing the deep grooves and fissures on the chewing surfaces of molars and premolars. It acts as a protective barrier against bacteria and plaque accumulation, reducing the risk of cavities in susceptible teeth. Manufactured as a liquid resin, it hardens upon application to form a durable, translucent seal.
This device is supplied as a single-use, non-sterile liquid intended for professional application by dental practitioners. It is classified as a Class II medical device under FDA regulations and adheres to the Medical Device Directive (MDD) in the EU. Storage requires protection from extreme temperatures and direct sunlight, and the product is dispensed in pre-filled syringes or applicators. No MRI safety considerations are specified, and its use is restricted to dental settings for preventive care.
Frequently asked questions
What is the Prevent Seal used for in clinical practice and how does it work?
The Prevent Seal is a pit and fissure sealant designed to prevent tooth decay by sealing the deep grooves and fissures on the chewing surfaces of molars and premolars. It acts as a protective barrier, blocking bacteria and plaque accumulation in these hard-to-clean areas, thereby reducing the risk of cavities in susceptible teeth. It is a liquid resin that hardens upon application to form a durable, translucent seal.
Is the Prevent Seal sterile and how is it supplied for use?
The Prevent Seal is supplied as a non-sterile liquid resin, intended for single-use only by dental practitioners. It comes pre-filled in syringes or applicators, ensuring ease of professional application in a clinical setting.
What storage conditions are required for the Prevent Seal?
The Prevent Seal must be stored protected from extreme temperatures and direct sunlight to maintain its integrity. Since it is non-sterile and single-use, it should also be kept in a clean, dry environment away from contamination until use.
What regulatory pathways does the Prevent Seal follow in the U.S. and EU?
In the U.S., the Prevent Seal was cleared through the FDA 510(k) process (Traditional route, Substantially Equivalent determination) under the Dental advisory committee. It is classified as a Class II medical device under FDA regulations. In the EU, it complies with the Medical Device Directive (MDD). Neither approval nor clearance status is implied beyond what is explicitly stated.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K122521 | Class II | Active |
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Manufacturer
- Manufacturer
- Itena Clinical
Sources (2)
- FDA 510(k) K122521 24 fields · synced Sep 18, 2026
- EUDAMED 1af00fc4-0721-4169-a440-84fe3f9c1b28 61 fields · synced Aug 3, 2026