(36 days)
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No
The document describes a dental porcelain material and its intended use and properties. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
No
The device is a dental porcelain used for fabricating restorations, which is a restorative, not therapeutic, purpose.
No
The device is a dental porcelain used to fabricate dental restorations, not to diagnose conditions.
No
The device description clearly states that "Imagine h.e. is a dental porcelain" and describes its physical properties and use as a dental restorative material. This indicates it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fabricate dental restorations (veneers, inlays, crowns, bridges) for dental technicians. This is a material used in vitro (outside the body), but it's for creating a physical restoration, not for diagnosing a condition or providing information about a patient's health status.
- Device Description: The description details the material composition and properties of a dental porcelain. It doesn't describe a test, reagent, or instrument used to analyze biological samples.
- Lack of Diagnostic Purpose: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental porcelain does not fit that definition.
N/A
Intended Use / Indications for Use
Imagine h.e. is a dental porcelain that is used by dental technicians to fabricate dental restorations to a metal or to press-ceramic restorations. It is suitable for veneering alloys with a high coefficient of thermal expansion [CTE(25 - 500°C): 16.1-16.7 x 10°K']], electroformed restorations, and heat-pressed ceramic frameworks made of the Imagine h.e. Press-Ceramic.
Imagine h.e. can be used for veneering of inlays, partial crowns, crowns, and bridges.
Product codes
EIH
Device Description
Imagine h.e. is a dental porcelain. It provides an easy to use and aesthetically pleasing dental restorative material to fabricate dental restorations. With its naturescent, brilliant shade effect, Imagine h.e. offers the dental technicians optimum conditions for achieving an exact reproduction of natural teeth.
Imagine h.e. is a dental glass-ceramic containing of leucite crystals (
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
AUG 1 6 2001
Premarket Notification 510(k)
Imagine h.e.
5. 510 (k) Summary
Submitter of 510(k):
Wieland Edelmetalle GmbH & Co. Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0
Contact person: Phone: Fax: e-mail:
Dr. Gerhard Polzer +49-7231-3705-219 +49-7231-357959 gerhard.polzer@wieland-dental.de
2001-06-21 Date of Summary:
Trade name:
Imagine h.e.
Classification name: Product code: C.D.R section: Classification:
Porcelain powder for clinical use ElH 872.6660 Class II
Legally marketed Duceragold equivalent device:
K931808 510(k) number:
1
Premarket Notification 510(k)
510 (k) Summary
Device description
Imagine h.e. is a dental porcelain. It provides an easy to use and aesthetically pleasing dental restorative material to fabricate dental restorations. With its naturescent, brilliant shade effect, Imagine h.e. offers the dental technicians optimum conditions for achieving an exact reproduction of natural teeth.
Imagine h.e. is a dental glass-ceramic containing of leucite crystals (