3m Curing Light Xl1500
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K934746 FDA 510(k)
- FDA Product Code
- EBZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6070 FDA 510(k)
- Regulation Number
- 872.6070 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Curing Light XL1500 is an ultraviolet activator designed for polymerizing dental composites and resins. Classified as a Class II medical device, it emits controlled ultraviolet light to cure dental restorative materials, ensuring proper hardening and adhesion during procedures.
This device is intended for use in dental clinics and offices, supplied as a reusable instrument. It is not sterile upon packaging and requires cleaning and maintenance per manufacturer instructions. The device carries an FDA 510(k) clearance (K934746) under regulation 872.6070, with a product code of EBZ, and is regulated under the Dental specialty classification. No MRI safety information or single-use designation is specified.
Frequently asked questions
What is the primary purpose of the 3M Curing Light XL1500 in a dental clinic?
The 3M Curing Light XL1500 is designed specifically to polymerize dental composites and resins by emitting controlled ultraviolet light. This process ensures that restorative materials harden properly and adhere correctly during dental procedures, such as fillings or crowns.
Is the 3M Curing Light XL1500 intended for single-use or reusable applications?
The device is supplied as a reusable instrument and is not intended for single-use. It requires cleaning and maintenance according to the manufacturer’s instructions to ensure proper functionality and safety.
What regulatory pathway was followed for FDA clearance of the 3M Curing Light XL1500?
The device received FDA clearance through a 510(k) submission, classified as substantially equivalent under regulation 872.6070. The clearance was granted on January 6, 1994, with the product code EBZ and falls under the Dental specialty classification.
Does the 3M Curing Light XL1500 come sterile upon packaging?
No, the device is not sterile upon packaging. It is intended for use in dental clinics and offices after proper cleaning and maintenance as directed by the manufacturer.
Are there any specific storage requirements mentioned for the 3M Curing Light XL1500?
The provided data does not specify detailed storage requirements, but since the device is reusable and not sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its functionality and longevity.
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: 3M CURING LIGHT XL1500 (K934746) - FDA 510 (k), 3M CURING LIGHT XL1500 510 (k) K934746 - FDA.report, 3M CURING LIGHT XL1500 — K934746 · DeviceClearance, PDF K934746 - 3M CURING LIGHT XL1500 - 510kdatabase.net, 3M Dental Curing Lights - Henry Schein
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K934746 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K934746 24 fields · synced Sep 19, 2026