(40 days)
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Not Found
No
The 510(k) 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 restoring function to teeth and does not offer therapeutic benefits.
No
The device is a filling material for restoring teeth, not for diagnosing conditions.
No
The device description clearly states it is a "filling material," which is a physical substance used in dental restorations, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of VIVALLOY HR is to be used as a filling material in the mouth, directly restoring teeth. It does not involve testing or analyzing samples taken from the body.
- The description focuses on a restorative material. The device description clearly states it's a "filling material for restoring function to teeth." This is a therapeutic or restorative function, not a diagnostic one.
- There is no mention of diagnostic testing or analysis. The intended use and description do not involve any processes related to identifying diseases, conditions, or physiological states through the examination of specimens.
Therefore, VIVALLOY HR is a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIVALLOY HR is to be used as a filling material for restoring function to teeth which have lost portions to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Single surface cavities such as Class I Two surface cavities such as MO, DO, FO, LO Three surface cavities such as MOD, FOD. Pinned onlays and half crowns. Core build-ups for cast half and full crowns. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Product codes
EJJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
dental professional such as DDS or DMD.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
Not Found
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
§ 872.3070 Dental amalgam, mercury, and amalgam alloy.
(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three bars above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 1998
AB ARDENT C/O Mr. Clyde E. Ingersoll ARDENT PRODUCT DEVELOPMENT 54 Riverview Avenue Tonawanda, New York 14150-5260
Re : K982458 Trade Name: VIVALLOY HR Requlatory Class: II Product Code: EJJ Dated: July 10, 1998 Received: July 15, 1998
Dear Mr. Ingersoll:
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 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). 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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in regulatory 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 not affect any obligation you might have under sections 531
1
Page 2 - Mr. Ingersoll
through 542 of 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 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 more 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
S. Putnam for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure a visual program and the se
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Image /page/2/Picture/18 description: The image shows a black and white graphic. The main element is a large, solid black shape that resembles a teardrop or an oval with a pointed bottom. To the left of this shape is a smaller, crescent-shaped black object. The background is plain white, providing contrast to the black shapes.
AB ARDENT
Generatorgatan 8 S-195 60 Marsta Sweden +046 8 591 210 20 Phone +046 8 591 161 83 FAX
510 (k)
VIVALLOY HR
ATTACHMENT #4
INDICATIONS FOR USE
510(k) Number: number not yet assigned
Device Name: VIVALLOY HR
VIVALLOY HR is to be used as a filling material for restoring function to teeth which have lost portions to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue.
Single surface cavities such as Class I Two surface cavities such as MO, DO, FO, LO Three surface cavities such as MOD, FOD. Pinned onlays and half crowns.
Core build-ups for cast half and full crowns.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Susan Purves
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Image /page/2/Picture/16 description: The image contains a black and white drawing of a bird's head. The bird has a large, curved beak and a visible eye. The drawing is simple and lacks detail, focusing on the basic shape and features of the bird's head.