Admira Seal
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by VOCO GmbH
Identifiers
- 510(k) Number
- K021842 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 Admira Seal is a dental sealant designed to protect the occlusal surfaces of permanent molars and premolars from caries by sealing the pits and fissures. It is classified as a Pit and Fissure Sealant and Conditioner, adhering to the anatomical contours of teeth to prevent bacterial penetration and acid demineralization.
This device is supplied as a single-use, non-sterile dental material intended for use in clinical dental settings. It is not MRI-safe and must be handled and stored according to manufacturer guidelines. Authorized under FDA 510(k) clearance and MDD compliance, it is regulated under the classification of Class II medical devices for dental applications.
Frequently asked questions
What is the primary purpose of the Admira Seal in dental treatment?
The Admira Seal is designed specifically to protect the occlusal (biting) surfaces of permanent molars and premolars by sealing the pits and fissures. This prevents bacterial penetration and acid demineralization, thereby reducing the risk of caries (tooth decay) in these vulnerable areas.
Is the Admira Seal intended for single-use or can it be reused?
The Admira Seal is explicitly supplied as a single-use dental material. It is not intended for reuse, and each application should use a fresh unit to maintain efficacy and hygiene standards in clinical settings.
How should the Admira Seal be stored, and is it sterile?
The Admira Seal is non-sterile and must be handled and stored according to the manufacturer’s guidelines. Since it is intended for clinical use, proper storage conditions—such as protection from moisture, extreme temperatures, and contamination—are critical to preserve its integrity before application.
What regulatory pathways has the Admira Seal undergone, and what classification does it hold?
The Admira Seal has been authorized under the FDA 510(k) clearance process, specifically classified as a Substantially Equivalent device under a Traditional clearance route. It is also compliant with the Medical Device Directive (MDD) and falls under Class II medical device classification for dental applications, as defined by regulatory authorities.
Can the Admira Seal be used in patients who require MRI scans, or is it MRI-safe?
The Admira Seal is not MRI-safe. This means it should not be used in patients who will undergo MRI procedures, as the material may interfere with imaging or pose safety risks during the scan.
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 | K021842 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA 510(k) K021842 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 18, 2026