SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER

K973513 · Espe GmbH & Co. Kg. · EBF · Dec 22, 1997 · Dental

Device Facts

• Record ID: K973513
• Device Name: SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
• Applicant: Espe GmbH & Co. Kg.
• Product Code: EBF · Dental
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 .

Device Story

Sinfony is a light-curing composite veneer material used by dental technicians in commercial or office laboratories. It serves as a restorative material for fixed crown and bridgework, telescopic/conical crowns, precision attachments, implant superstructures, adhesive bridgework, laminate veneers, and for individualizing denture teeth or long-term temporary restorations. Compared to predicate Visio-Gem systems, Sinfony offers improved mechanical properties, allowing for full coverage of crown and bridgework veneers, including occlusal areas. The material is applied extra-orally by the technician to create or modify dental prosthetics. The final cured composite provides aesthetic and mechanical restoration of dental structures, benefiting patients by providing durable, customized dental replacements.

Clinical Evidence

Bench testing only. Physical and technical characteristics were evaluated and compared to predicate devices using ISO 10477 and DIN 53456 standards. Evaluated parameters included surface finish, flexural strength, water absorption, solubility, color and translucency, color stability, and surface hardness.

Technological Characteristics

Light-curing composite veneer material. Materials tested per ISO 10477 and DIN 53456. Characteristics include surface finish, flexural strength, water absorption, solubility, color/translucency, color stability, and surface hardness. Designed for extra-oral laboratory use by dental technicians.

Indications for Use

Indicated for dental laboratory use for full and partial coverage of fixed crown and bridgework, telescopic and conical crowns, precision attachments, implant superstructures, adhesive bridgework, laminate veneers, and for individualizing denture teeth and long-term temporary restorations.

Regulatory Classification

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.

Predicate Devices

• Visio-Gem® (K833757)
• Visio-Gem® Art-System (K905604)

Submission Summary (Full Text)

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## 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

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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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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# STATEMENT OF INDICATIONS FOR USE

K973513

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}\$

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