Dentition Integrating Material
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020287 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 Dentition Integrating Material is a fluoride-releasing, light-cured resin-based dental sealant designed to bond to tooth surfaces. It is classified as a pit and fissure sealant and conditioner, intended to prevent dental caries by sealing the occlusal surfaces of molars and premolars.
This material is supplied as a single-use dental product and requires light activation for curing. It is regulated under FDA 510(k) clearance (K020287) as a Class II device under regulation number 872.3765, with no third-party review. Sterility and MRI safety are not specified in the available data, and it is intended for use in dental settings only.
Frequently asked questions
What is the primary purpose of the Dentition Integrating Material in dental practice?
The Dentition Integrating Material is designed as a fluoride-releasing, light-cured resin-based dental sealant specifically for pit and fissure sealing. Its main purpose is to bond to the occlusal surfaces of molars and premolars to prevent dental caries by creating a protective barrier against bacteria and acid attacks.
How is the Dentition Integrating Material activated and used in a clinical setting?
This material requires light activation for curing, meaning it must be exposed to a dental curing light to harden properly. It is supplied as a single-use product, intended for application directly onto tooth surfaces to seal pits and fissures, reducing the risk of cavities.
Is the Dentition Integrating Material reusable, or is it intended for single-use only?
The Dentition Integrating Material is explicitly described as a single-use dental product. Each application requires a new unit, ensuring sterility and preventing cross-contamination between patients.
What regulatory pathway was followed for the FDA clearance of this device?
The Dentition Integrating Material received FDA clearance through a 510(k) submission, classified as a Class II device under regulation number 872.3765. The submission was determined to be substantially equivalent to a predicate device and was reviewed by the Dental (DE) Advisory Committee without third-party involvement. The clearance number is K020287, and the decision was made on April 12, 2002.
Are there any specific storage requirements mentioned for the Dentition Integrating Material?
The provided data does not explicitly detail storage conditions for the Dentition Integrating Material. However, as a single-use dental product, it should be stored according to standard dental material guidelines—typically in a cool, dry place, protected from direct sunlight and extreme temperatures. Always refer to the manufacturer’s instructions for precise storage recommendations.
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: DENTITION INTEGRATING MATERIAL (K020287) — FDA 510 (k) | Innolitics, PDF K020287 - Dentition Integrating Material, Dentition Integrating Material - Beudamed, PDF K020287 - qx-files.yaozh.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020287 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K020287 24 fields · synced Sep 20, 2026