(96 days)
Not Found
No
The device is described as a light-curing composite veneer material and the performance studies focus on material properties, not algorithmic performance. There are no mentions of AI, ML, or image processing.
No
The device is a light-curing composite veneer material used by dental technicians to create dental restorations; it does not directly treat a disease or condition in a patient.
No
Explanation: The device is a light-curing composite veneer material used for restorative dental applications, not for diagnosing medical conditions.
No
The device is described as a "light-curing composite veneer material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Sinfony® system is a light-curing composite veneer material for various dental restorations. This involves working on dental prosthetics and structures outside the body.
- Device Description: It is described as a "light-curing composite veneer material," which is a material used in dental fabrication.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The process described is the fabrication of dental restorations.
- Intended User/Care Setting: The intended user is a "dental technician outside the mouth in a commercial dental laboratory or laboratory in a dental office." This further reinforces that the work is being done on dental materials and prosthetics, not on patient specimens for diagnostic purposes.
IVD devices are specifically designed to perform tests on biological samples to gain information about a person's health. The Sinfony® system is a material used in the creation of dental prosthetics.
N/A
Intended Use / Indications for Use
The Sinfony® system is indicated for use as a light-curing composite veneer material for:
- full and partial coverage of:
- fixed crown and bridgework .
- telescopic and conical crowns .
- precision attachments
- implant superstructures .
- adhesive bridgework .
- laminate veneers .
- o individualizing denture teeth
- individualizing long-term temporary restorations .
Product codes
EBF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technician outside the mouth in a commercial dental laboratory or laboratory in a dental office.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
physical and technical characteristics of Sinfony® have been compared to those of Visio-Gem® using tests undertaken pursuant to ISO 10477 and DIN 53456. These characteristics include surface finish, flexural strength, water absorption, solubility, color and translucency, color stability, and surface hardness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
II. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
ESPE is submitting a 510(k) premarket notification for modifications to its Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604), to create modified veneer materials that provide improved mechanical properties and aesthetics. The Sinfony® system is indicated for use as a light-curing composite veneer material for:
- full and partial coverage of:
- fixed crown and bridgework .
- telescopic and conical crowns .
- precision attachments
- implant superstructures .
- adhesive bridgework .
- laminate veneers .
- o individualizing denture teeth
- individualizing long-term temporary restorations .
ESPE is claiming substantial equivalence to its previously cleared Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604). The products have similar intended uses, except that, due to its improved mechanical properties, Sinfony® provides full (not just partial) coverage of crown and bridgework veneers, including occlusal areas. Sinfony® and the Visio-Gem® products also
WA01A/133508.1
1
have similar ingredient composition. Further, both products are intended for use by a dental technician outside the mouth in a commercial dental laboratory or laboratory in a dental office. To support substantial equivalence to the predicate product, the physical and technical characteristics of Sinfony® have been compared to those of Visio-Gem® using tests undertaken pursuant to ISO 10477 and DIN 53456. These characteristics include surface finish, flexural strength, water absorption, solubility, color and translucency, color stability, and surface hardness.
ESPE's 510(k) has been submitted on September 17, 1997, by Dr. Barbara Wagner-Schuh at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 1997
Dr. Barbara Wagner-Schuh Requlatory Affairs ESPE GmbH & Company KG. ESPE Platz D-82229 Seefeld, OBB.
K973513 Re : Trade Name: Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier Requlatory Class: II Product Code: EBF Dated: December 1, 1997 Received: December 4, 1997
Dear Dr. Waqner-Schuh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Dr. Wagner-Schuh
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
Device Name:
(-10(K) 4
Sinfony® Light-Curing Crown and Bridge Full Coverage Composite Material
Indications for Use:
.
ﻠﺴﻠﺔ
Full and partial coverage of:
- fixed crown and bridgework .
- telescopic and conical crowns .
- precision attachments .
- implant superstructures .
- adhesive bridgework ◆
- laminate veneers .
- individualizing denture teeth
individualizing long-term temporary restorations
Swarup Kumar
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
Prescription Use __ X
Or
Over-the-Counter Use $\underline{No}$
WA01A/133508.1