(35 days)
Not Found
No
The summary describes a dental varnish material and does not mention any AI or ML components or functionalities.
No
The device is described as a "surface sealing and finishing material" whose intended use is "on polymerized composite surfaces, denture bases, and temporary crowns and bridges". This functionality does not indicate a therapeutic purpose, but rather a cosmetic or protective one.
No.
The "Intended Use / Indications for Use" states that the device is a "surface sealing and finishing material," which is a treatment or restorative function, not a diagnostic one.
No
The device description clearly states it is a "material" and a "surface coating material," indicating 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 is for "surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges." This describes a material applied to dental devices, not a test performed on biological samples to diagnose a condition.
- Device Description: The description states it's a "single-component, acrylate-based, light-curing surface coating material for dental applications." This further reinforces its nature as a dental material, not a diagnostic test.
- 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 specific analytes
- Providing information for diagnosis, monitoring, or screening of a disease or condition.
Therefore, SternVantage Varnish LC is a dental material used for surface treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SternVantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.
Product codes
EBI
Device Description
The Stern Vantage Varnish LC material is a single-component, acrylate-based, light-curing surface coating material for dental applications.
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
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
Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Varnish LC are equivalent to those of the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Sterngold ImplaMed 510(k) Premarket Notification
8 - 1999 JAN
December 2, 1998
SternVantage Varnish LC
00040
510(k) Summary
| ్రాలు ప్రస్తుం | |
|---|---|
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Trade Name:
Sponsor:
Sterngold ImplaMed 23 Frank Mossberg Drive P.O. Box 2967 Attleboro, MA 02703-0967 Registration #2921595
SternVantage Varnish LC
Denture relining, repairing and rebasing resin Device Generic Name:
Classification:
According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II.
Predicate Devices: The proposed Stern Vantage LC is substantially equivalent to the Palaseal material marketed by Kulzer, Inc. which was cleared for marketing by FDA in K892452.
Product Description:
The Stern Vantage Varnish LC material is a single-component, acrylate-based, light-curing surface coating material for dental applications.
Indications for Use:
Stern Vantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.
Safety and Performance:
Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Varnish LC are equivalent to those of the predicate device.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Stern Vantage Varnish LC has been shown to be safe and effective for its intended use.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 JAN
Mr. Gordon Nelson Director Sterngold ImplaMed 23 Frank Mossberg Drive P.O. Box 2967 02703-0967 Attleboro, Massachusetts
K984341 Re : SternVantage Varnish LC, Model 221001 Trade Name: Requlatory Class: II Product Code: EBI 2, 1998 Dated: December December 4, 1998 Received:
Dear Mr. Nelson:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 Reqister. Please note: this response to your premarket notification submission does 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 regulations.
2
Page 2 - Mr. Nelson
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) 594-4692. 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 ene regaracion onesion" (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
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Sterngold ImplaMed 510(k) Premarket Notification
Page 1 of
510(k) Number (if known): K984341
Device Name: SternVantage Varnish LC
Indications for Use:
SternVantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription UseD (Per 21 CFR 801.109)
OR
Over-the -Counter Use
SwartRumn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number