(40 days)
Not Found
Not Found
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 used to restore function to teeth, indicating a restorative rather than therapeutic purpose.
No
The device is described as a "filling material for restoring function to teeth," indicating a therapeutic rather than diagnostic purpose. It is used after "removal of carious tissue," implying that a diagnosis of caries has already occurred.
No
The device description and intended use clearly describe a physical filling material (AMALCAP PLUS) used for dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a filling material for restoring teeth. This is a direct treatment applied to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: While the description is "Not Found," the intended use clearly places it as a restorative dental material.
- Anatomical Site: The anatomical site is "teeth," which are part of the patient's body.
- Nature of the Device: The description of its use as a "filling material" and for "restoring function" indicates a therapeutic or restorative device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
AMALCAP PLUS 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.
Product codes
EJJ
Device Description
Not Found
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
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
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): 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.
Not Found
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
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 (HHS) of the United States of America. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with healthcare, with three intertwined snakes and a staff.
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: K982456 AMALCAP PLUS Trade Name: Regulatory 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. ਰ 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 requlatory 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
1
Page 2 - Mr. Ingersoll
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 (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 requlation 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
S. Sutron 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
2
AB ARDENT
Generatorgatan 8 S-195 60 Marsta Sweden Phone +046 8 591 210 20 FAX +046 8 591 161 83
510 (k)
AMALCAP PLUS
ATTACHMENT #4
INDICATIONS FOR USE
510(k) Number: number not yet assigned
Device Name: AMALCAP PLUS
AMALCAP PLUS 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 Runney
and Adversion Cuntrol. and Coractif the phat Covices
510(k) Number: K485456