(49 days)
No
The summary describes a dental filling material and does not mention any AI or ML components or functionalities.
No.
The device is a filling material for deciduous teeth, which is a restorative material used in dentistry, not a therapeutic device.
No
The device description indicates it is a "filling system for cavities of deciduous teeth," and its intended use is "for fillings of deciduous teeth." This describes a restorative or therapeutic device, not one used for diagnosis.
No
The device description clearly states it is a "light-curing, colored, radiopaque and fluoride containing compomer filling system," which are physical materials and hardware components, 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 for "fillings of deciduous teeth." This describes a material used within the body for a therapeutic purpose (filling cavities), not a test performed outside the body on samples to diagnose or monitor a condition.
- Device Description: The description details a "light-curing, colored, radiopaque and fluoride containing compomer filling system." This is a material used in dentistry for restorative procedures.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic or monitoring information
Therefore, Twinky Star NF is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Twinky Star NF is intended for fillings of deciduous teeth.
Product codes
EBF
Device Description
Twinky Star NF is a light-curing, colored, radiopaque and fluoride containing compomer filling system for cavities of deciduous teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
deciduous teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arabesk Top, K994268
Reference Device(s)
K994268, K003153, K053391, K974772
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
Image /page/0/Picture/0 description: The image shows a logo with four distinct shapes arranged horizontally. The first shape resembles an upside-down triangle with a small rectangle at the top. The second shape is a solid circle with a smaller circle cut out in the center. The third shape is a circle with a wedge-shaped cutout. The fourth shape is a solid circle with a smaller circle cut out in the center, similar to the second shape.
Anton-Flettner-Straße 1 27472 Cuxhaven · Germany +49 4721 719-0 04721 719-109 49 4721 719-140 www.voco.de · info@yoco.de
ﺎ -T VOCO GmbH · Postfach 7 67 · 27457 Cuxhaven · Germanv
JAN 2 2 2007
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L
510(k) SUMMARY
Mr. M.Th. Plaumann Contact:
Date prepared: December 01, 2006
Trade orproprietary name: Twinky Star NF
Classification name: Material Tooth Shade, Resin, (872.3690)
Predicate device: Arabesk Top, K994268
Device description: Twinky Star NF is a light-curing, colored, radiopaque and fluoride containing compomer filling system for cavities of deciduous teeth.
Intended use: Twinky Star NF is intended for fillings of deciduous teeth.
Technological
characteristics:
The components of Twinky Star NF are found in the legally marketed devices K994268, K003153, K053391, K974772.
The prior use of the components Twinky Star NF in legally marketed devices support our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary.
We believe that the prior use of the components of Twinky Star NF in legally marketed devices and the performance data and results provided support the safety and effectiveness of Twinky Star NF for the intended use.
VOCO GmbH, December 01, 2006
M.Th. Plaumann
Managing Director
1
Image /page/1/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Manfred T. Plaumann Managing Director VOCO GmbH Anton-Flettner-Strasse 1-3 27472 Cuxhaven GERMANY
JAN 2 2 2007
Re: K063604
Trade/Device Name: Twinky Star NF Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 01, 2006 Received: December 04, 2006
Dear Mr. Plaumann:
. . . . . . . . . .
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 – Mr. Manfred T. Plaumann
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-S. Lin, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Mau Hossilianten .
Enclosure
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Indications for Use Statement
| 510(k) Number: | K063604 |
|---|---|
| Device Name: | Twinky Star NF |
| Indications for Use: |
Twinky Star NF is intended for fillings of deciduous teeth.
| Prescription Use | X |
|---|---|
| ------------------ | ---------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quare
਼ੁਨ (ਮੌ) i J Anesthesiology, General Hospital, ා Control, Dental Devices
Kob3604