(47 days)
K 973513, K 964578, PERTAC® II (K 962440), TARGIS® system (K 962878), FIBREKOR® (K 964578), PROTEMP® GARANT (K 950203)
K 990763, K 991220, K 950203
No
The device description and intended use clearly define it as a dental resin material for restorations, with no mention of AI/ML capabilities or related data/performance metrics.
No.
The device is a restorative material for dental work, not a device designed for therapeutic treatment (e.g., pain relief, healing, or rehabilitation).
No
Explanation: The device description clearly states "SINFONY is classified as a tooth shade resin material" and its intended use is for "full veneering of crowns and bridges" and "fabrication of inlays and onlays." These are restorative, not diagnostic, functions.
No
The device description explicitly states it is a "tooth shade resin material" composed of methacrylates, which 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 clearly describes the device as a material for fabricating dental restorations (crowns, bridges, inlays, onlays, etc.) and for extraoral repairs and customization of artificial teeth. These are all applications related to the physical restoration and modification of teeth, not for diagnosing diseases or conditions.
- Device Description: The device is classified as a "tooth shade resin material" and its purpose is described as being used for "full and partial coverage of crowns and bridges and as a material for the fabrication of inlays and onlays to restore carious lesions or structural defects in teeth." This aligns with a dental restorative material, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device's function is entirely focused on the physical restoration and modification of teeth.
N/A
Intended Use / Indications for Use
Full veneering of crowns and bridges
Complete crowns
Inlays/onlays
Fiber reinforced crowns and bridges
Direct bonded bridges
Telescopic and conical crowns
Attachments and implant works
Veneers
Long term temporary restorations and their characterization
Customization of acrylic and ceramic artificial teeth
Extraoral repairs
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
SINFONY is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to be used for full and partial coverage of crowns and bridges and as a material for the fabrication of inlays and onlays to restore carious lesions or structural defects in teeth. The composition of SINFONY® was only changed slightly, a photo stabilizer has been added to some particular materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
To give evidence that SINFONY® is capable for the new indications, performance test data are provided and compared to the predicate devices PERTAC® II (K 962440) TARGIS® system (K 962878), FIBREKOR® (K 964578) and PROTEMP® GARANT (K 950203), which are released as materials for the fabrication of inlays and onlays, crowns and fiber reinforced bridges respective. The comparison shows that SINFONY is as effective as the predicate devices which are all well established on the world market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 973513, K 964578, PERTAC® II (K 962440), TARGIS® system (K 962878), FIBREKOR® (K 964578), PROTEMP® GARANT (K 950203)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K 990763, K 991220, K 950203
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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SEP 222 1999 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ll.
Submitter
ﺰ ﺗﻮﺍﺻﻞ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
| Name: | ESPE Dental AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas Petermann, |
| Manager U.S. Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| Andreas_Petermann@ESPE.de | |
| Date: | August 3, 1999 |
| Name of Device | |
| Proprietary Name: | SINFONY® |
| Classification Name: | Tooth shade resin material |
| Common Name: | Crown and bridge veneering composite |
| material | |
| Predicate Device | |
| SINFONY® (old version) by ESPE | K 973513 |
TARGIS® system by IVOCLAR .................................................................................................................................................... FIBREKOR® by JENERIC/PENTRON.... K 964578 PERTAC® II by ESPE ...........................................................................................................................................................
PROTEMP® GARANT by ESPE ......................................................................................................................................................
Image /page/0/Picture/6 description: The image shows the logo for 510(k) SINFONY. The logo includes the text "510(k) SINFONY" in a sans-serif font, with the registered trademark symbol next to "SINFONY". Below the text is a stylized image of a tree on the left and the word "ESPE" in a bold, sans-serif font on the right.
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| VITRON® M by ESPE......................................K 990763 |
|---|
| VITRON® H by ESPE......................................K 991220 |
Description for the Premarket Notification
SINFONY is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to be used for full and partial coverage of crowns and bridges and as a material for the fabrication of inlays and onlays to restore carious lesions or structural defects in teeth.
On December 22, 1997 SINFONY® as a veneering material for full and partial coverage of bridges and crowns received 510(k) clearance. As a demand of customers, the range of indications will now be expanded on material for fabrication of complete crowns, inlays and onlays and fiber reinforced crowns and bridges.
Pursuant to the 510(k) Memorandum #K97-1, released on January 10, 1997, "Deciding when to submit a 510(k) for a change to an existing device", the changes of SINFONY® affect the labeling and the indications for use and require, therefore, the submission of a new 510(k).
To give evidence that SINFONY® is capable for the new indications, performance test data are provided and compared to the predicate devices PERTAC® II (K 962440) TARGIS® system (K 962878), FIBREKOR® (K 964578) and PROTEMP® GARANT (K 950203), which are released as materials for the fabrication of inlays and onlays, crowns and fiber reinforced bridges respective. The comparison shows that SINFONY is as effective as the predicate devices which are all well established on the world market.
The composition of SINFONY® was only changed slightly, a photo stabilizer has been added to some particular materials. This photo stabilizer is a well-known compound and also contained in some other already 510(k)-cleared ESPE products (Vitron® M, K 990763, Vitron® H, K 991220, Protemp® Garant, K 950203). Therefore a new toxicological assessment is not required in our point of view.
Image /page/1/Picture/7 description: The image shows the logo for 510(k) Sinfony ESPE. The logo is in black and white and features the text "510(k) SINFONY" at the top, with the registered trademark symbol next to it. Below the text is a logo that includes a tree-like image on the left and the word "ESPE" on the right.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a series of lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1999
Dr. Andreas Petermann Manager U.S. Regulatory Affairs ESPE Dental AG ESPE Plaza D-82229 Seefeld, Bavaria Germany
Re: K992645 Sinfony® Trade Name: Regulatory Class: II Product Code: EBF Dated: Auqust 3, 1999 Received: August 6, 1999
Dear Dr. Petermann:
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 against 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 -Dr. Petermann
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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,
Rubaci Cucerite/for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a sequence of alphanumeric characters in a bold, sans-serif font. The characters are 'K992645', with the 'K' being the only letter in the sequence. The numbers are a mix of curved and straight lines, creating a distinct visual pattern. The image has a high contrast, with the characters appearing in solid black against a white background.
lll. STATEMENT OF INDICATIONS FOR USE
Device Name:
SINFONY®
Indications for use:
Full veneering of crowns and bridges
Complete crowns
Inlays/onlays
Fiber reinforced crowns and bridges
Direct bonded bridges
Telescopic and conical crowns
Attachments and implant works
Veneers
Long term temporary restorations and their characterization
Customization of acrylic and ceramic artificial teeth
Extraoral repairs
Susan Runar
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices 2444 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
Image /page/4/Picture/19 description: The image shows the text "510(k) SINFONY" on the top line, with a registered trademark symbol next to SINFONY. Below that is an image of a tree inside of a square, and to the right of that is the word "ESPE" in large, bold letters. The text and image appear to be a logo or trademark for a product or company.
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