(80 days)
Not Found
Not Found
No
The summary describes a dental amalgam, a material used for fillings, with no mention of software, image processing, or AI/ML terms.
No
The device is a dental amalgam used for obturation of cavities, which is a restorative material and not a device intended for therapy or treatment of disease.
No
The intended use of SECURALLOY ™ is for "obturation of the cavities of posterior teeth and building of false stumps," which describes a treatment or restorative function, not diagnosis.
No
The device is described as a dental amalgam, which is a physical material used for filling cavities. This is a hardware device, 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 use in the obturation of the cavities of posterior teeth and building of false stumps." This describes a material used directly within the patient's mouth for dental restoration.
- Anatomical Site: The anatomical site is "posterior teeth," which is a part of the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples taken from the body (blood, urine, tissue, etc.).
- Providing information about a physiological state, disease, or condition.
- Being used in a laboratory setting.
IVDs are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This dental amalgam is a material used in the body for a restorative purpose.
N/A
Intended Use / Indications for Use
SECURALLOY ™ is a dental amalgam for use in the obturation of the cavities of posterior teeth and building of false stumps.
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
posterior 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)
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 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 is a black and white logo for the Department of Health & Human Services (USA). The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 1998
Specialites Septodont C/O Mr. Peter S. Reichertz Counsel for Specialites Septodont Arent Fox Kintner Plotkin & Kahn, PLLC 1050 Connecticut Avenue N.W. Washington, DC 20036-5339
Re : K982671 Trade Name: SECURALLOY™ Requlatory Class: II Product Code: EJJ July 30, 1998 Dated: Received: July 31, 1998
Dear Mr. Reichertz:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Reichertz
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 requlation (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
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,
Timothy A. Ulatowski
thy A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Enclosure
2
510(k) Nunber (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
SECURALLOY ™ is a dental amalgam for use in the obturation of the cavities of posterior teeth and building of false stumps.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEROBOD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runoer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 198217 510(k) Number
Prescription Usc X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
02/13 '96 11:07