(122 days)
K95533
K95533
No
The device description and intended use focus on a material reformulation and curing process, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The document describes a repair material used for minor adjustments or repairs to a dental appliance during fabrication in a commercial dental laboratory. It is part of a fabrication system for crowns and bridges and is not directly applied to a patient for therapeutic purposes.
No
Explanation: The device is described as a resin for repairing dental appliances during fabrication, not for diagnosing conditions.
No
The device is a material (resin) used in a fabrication process, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for performing minor adjustments or repairs to a dental appliance during the fabrication procedure. This is a manufacturing or repair process for a medical device (the dental appliance), not a diagnostic test performed on a biological sample from a patient.
- Device Description: The description details a material used in the fabrication process of a dental appliance. It doesn't mention any interaction with biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a material used in the creation and repair of a dental prosthesis, which falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BelleGlass Dual Cure Enamel Repair Resin is indicated for use with the BelleGlass HP Heat + Pressure Cure Composite Crown and Bridge Fabrication System when it is necessary to perform minor adjustments or repairs to an appliance during the fabrication procedure.
Product codes
EBF
Device Description
BelleGlass HP Dual Cure Enamel Repair Material - A very small amount of photoinitiating agent (
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Ka7176a
SEP 1 2 1997
Page 1 of 2
510 ( k ) Summary
Statement of Safety an Effectiveness
BelleGlass HP Enamel Repair Material
Submitter
Sybron Dental Specialties Inc. 1717 West Collins Avenue Orange, CA 92867 (714) 516-7486 - Phone (714) 516-7488 - FAX William R. Pike - Contact Person
Device Name
Trade Name: BelleGlass HP Enamel Repair Material Common Name: Dual Cured Composite Crown and Bridge Fabrication Material Classification Name: Tooth shade resin material, Class II, 21 CFR 872.3690
Devices for which Substantial Equivalence is Claimed
BelleGlass HP Heat and Pressure Cure Enamel Repair Material ( Kerr Corporation )
BACKGROUND
Kert/Dental Materials Center currently manufactures a product marketed under the Tradename BelleGlas HP Dental Laboratory Crown and Bridge Fabrication System ( 510 ( k ) Reference K95533) ). It is used in commercial dental laboratories to fabricate composite based crowns and bridgework. This product has been on the market since March, 1996. A component material in the current product is a heat + pressure cured enamel repair to be used for minor adjusments or repairs to appliances damaged during processing. BelleGlass Dual Cure Enamel Repair Material is simply a reformulation of the heat and pressure cure material to allow the material to be light cured so that it is more stable during the transfer to the Heat + Pressure Curing Device. This is a product modification based on requests from customers for a more durable, with respect to paste deformation and flow, during the transfer procedure.
BelleGlass HP Dual Cure Enamel Repair Material
A very small amount of photoinitiating agent (