(54 days)
Not Found
No
The summary describes a dental alloy and its performance in standard biocompatibility tests, with no mention of AI or ML.
No
The device is a dental alloy for restorations, which is a material used to repair teeth, not a device intended to treat or cure a disease or medical condition.
No
The device is a dental alloy for restorations, which is a treatment, not a diagnostic device.
No
The device description clearly states it is a "lathe cut, silver-based dental amalgam alloy," which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "stress-bearing Class 1 and Class 2 restorations" in dentistry. This describes a material used within the body for structural repair, not a test performed outside the body on samples to diagnose or monitor a condition.
- Device Description: The description confirms it's a "dental amalgam alloy," a material used for filling cavities.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The performance studies mentioned (toxicity, mutagenicity, etc.) are standard biocompatibility tests for materials intended for use in the body, not performance metrics for a diagnostic test.
N/A
Intended Use / Indications for Use
21st CENTURY ALLOY is a dental alloy designed for stress-bearing Class 1 and Class 2 restorations.
Product codes
EJJ
Device Description
21st CENTURY ALLOY is a lathe cut, silver-based dental amalgam alloy designed for stress-bearing Class 1 and Class 2 restorations.
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
21st CENTURY ALLOY was tested for Acute Oral Toxicity, Mutagenicity, Cytotoxicity, and Pulpal Irritation. All tests showed equivalency to other currently distributed dental amalgam alloy.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) SUMMARY
DEC 17 1997
Image /page/0/Picture/2 description: The image shows the word "Dentsply" in a bold, stylized font. The letters are all capitalized and connected to each other. The font is sans-serif and has a slightly angled appearance. The word is black and the background is white.
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872
::
(717) 845-7511 Fax (717) 854-2343
P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
October 22, 1997 DATE PREPARED:
TRADE OR PROPRIETARY NAME: 21st CENTURY ALLOY
872.3050 - amalgam alloy CLASSIFICATION NAME:
K801690 PREDICATE DEVICE: Valiant® Amalgam Alloy Dispersalloy® Dispersed Phase Alloy Pre-1977
DEVICE DESCRIPTION AND INTENDED USE: 21st CENTURY ALLOY is a lathe cut, silver-based dental amalgam alloy designed for stress-bearing Class 1 and Class 2 restorations.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in 21st CENTURY ALLOY have been used in legally marketed devices. 2185 CENTURY ALLOY contains those metallic elements and elemental proportions identical to that commercially used in the past 25 years. Such alloys have historically been proven to be safe and effective as dental restorative materials.
21st CENTURY ALLOY was tested for Acute Oral Toxicity, Mutagenicity, Cytotoxicity, and Pulpal Irritation. All tests showed equivalency to other currently distributed dental amalgam alloy.
We believe that the prior use of the components of 21st CENTURY ALLOY in legally marketed devices, the performance data, and the results of biocompatibility testing support the safely and effectiveness of 21st CENTURY ALLOY for the intended uses.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Mr. P. Jeffery Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405
K974035 Re: Trade Name: Century Alloy Requlatory Class: II Product Code: EJJ Dated: October 22, 1997 Received: October 24, 1997
Dear Mr. Lehn:
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 reqistration, listinq of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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
2
Page 2 - Mr. Lehn
not affect any obligation you miqht have under sections 531 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 beqin 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,
Clatrust
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
510(K) Number:
Device Name:
_21st CENTURY ALLOY
21°T CENTURY ALLOY is a dental alloy designed for stress-bearing
Class 1 and Class 2 restorations.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K074035 |
| Prescription Use | Yes |
| OR | |
| Over-The-Counter Use No |
000007