Kulzer Inlay System
FDA 510(k)Class II (US FDA 510(k))
by Kulzer, Inc.
Identifiers
- 510(k) Number
- K892454 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Kulzer Inlay System is a dental device classified as a resin-based inlay material, designed for restoring damaged or missing tooth structure. It is intended for use in dental restorations where a durable, tooth-colored filling is required, providing structural integrity and aesthetic matching to natural teeth. The system falls under the product code EBF, indicating its use in dental applications involving tooth shade materials.
This system is supplied as a reusable dental material kit, intended for use in clinical settings by dental professionals. The components are non-sterile and must be sterilized or prepared according to standard dental protocols prior to use. The device was cleared by the FDA under a 510(k) submission (K892454) in 1989, with no specific MRI safety or single-use requirements noted. Storage should follow manufacturer guidelines for dental resins to maintain material integrity.
Frequently asked questions
What is the Kulzer Inlay System used for?
The Kulzer Inlay System is a resin-based dental material designed specifically for restoring damaged or missing tooth structure. It is intended for use in dental restorations where a strong, aesthetically matching filling is required, ensuring both structural integrity and a natural appearance. This makes it ideal for cases where traditional fillings may not provide sufficient durability or visual blending with the surrounding teeth.
How is the Kulzer Inlay System supplied and prepared for use?
The Kulzer Inlay System is supplied as a reusable kit intended for clinical use by dental professionals. The components are non-sterile and must be sterilized or prepared according to standard dental protocols before use. This ensures safety and compliance with infection control measures in dental practices.
Is the Kulzer Inlay System single-use or reusable?
The Kulzer Inlay System is not single-use; it is designed as a reusable kit for dental professionals. However, individual components or materials used in restorations may be consumed during procedures. The kit itself can be reused after proper cleaning and sterilization, as outlined in the manufacturer’s guidelines.
What storage instructions should be followed for the Kulzer Inlay System?
To maintain the integrity of the resin materials in the Kulzer Inlay System, storage should adhere to the manufacturer’s guidelines for dental resins. This typically includes keeping the kit in a clean, dry environment away from direct sunlight or extreme temperatures, as these factors can degrade the material over time. Always follow the provided instructions to preserve performance and safety.
Does the Kulzer Inlay System have any specific MRI safety considerations?
The provided data does not specify any particular MRI safety requirements for the Kulzer Inlay System. However, dental restorations generally contain composite materials that are non-metallic and unlikely to interfere with MRI procedures. For patient safety, clinicians should always verify compatibility with their specific MRI equipment and protocols, especially if the patient requires imaging after restoration.
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: K892454 - KULZER INLAY SYSTEM | FDA 510 (k) | Kulzer, Inc., KULZER INLAY SYSTEM (K892454) — FDA 510 (k) | Innolitics, PDF K892454 - Kulzer Inlay System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K892454 | Class II | Active |
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Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA 510(k) K892454 24 fields · synced Oct 1, 2026