(16 days)
(k) 923714, (k) 895070, (k) 883036
Not Found
No
The device is a dental alloy, and the summary describes its use in traditional dental restorations without mentioning any computational or analytical capabilities.
No
The device is described as an alloy for dental restorations (crowns and bridges), which are used to replace or restore damaged or missing teeth. While it serves a restorative purpose, it does not actively treat a disease or medical condition in the way a therapeutic device would (e.g., delivering medication, stimulating tissues, or performing diagnostic functions for treatment decisions). It is a passive restorative material.
No.
The device is described as a "White Crown and Bridge Alloy" used for "Dental Restorations," indicating it is a restorative material, not a diagnostic tool.
No
The device is described as a "Precious Alloy for use in Crown and Bridge Dental Restorations" and a "White Crown and Bridge Alloy." This clearly indicates a physical material, 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 "Precious Alloy for use in Crown and Bridge Dental Restorations." This describes a material used in the body for structural purposes, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description is of a "White Crown and Bridge Alloy," which is a material.
- 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.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a dental material used for restorations, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Precious alloy for use in Crown and Bridge dental restorations.
Product codes (comma separated list FDA assigned to the subject device)
EJS
Device Description
Sterngold 66 is a White Crown and Bridge Alloy.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Guidance Document for the Preparation of Premarket Notifications [510(k) s] for Dental Alloys).
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.
(k) 923714, (k) 895070, (k) 883036
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
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
0
April 15, 2002
Sterngold 66
510(k) Summary
MAY 1 6 2002
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Sterngold is required on story the this Premarket Pursuant to 312(1)(3)(A) of the Food, Drag and Ossinfornition respecting safety and effectives or state that Notitication either an " ...adequale summalled responsible submit and of the safety and effectiveness information. The summary is as follows:
Trade Name:
Sterngold 66
Sponsor:
Sterngold 23 Frank Mossberg Drive P.O. Box 2967 Attleboro, MA 02703-0967 Registration #2921595
Dental Alloy Device Generic Name:
Classification:
According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II.
Predicate Devices:
| Alloy Name | 510(k) | Manufactured By |
|---|---|---|
| Symphony | (k) 923714 | Jelenko |
| Select White | (k) 895070 | Leach & Dillon |
| Palliag NF III | (k) 883036 | Degussa Dental |
Product Description:
Sterngold 66 is a White Crown and Bridge Alloy.
Indications for Use:
Precious alloy for use in Crown and Bridge dental restorations.
Safety and Performance:
This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Guidance Document for the Preparation of Premarket Notifications [510(k) s] for Dental Alloys).
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, Stemgold 66 has been shown to be safe and effective for its intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three lines representing the branches of government and two intertwined snakes representing medicine and public health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Ms. Maria Rao Quality Manager Sterngold 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967
Re: K021367
Trade/Device Name: Sterngold 66 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: Class II Product Code: EJS Dated: April 15, 2002 Received: April 30, 2002
Dear Ms. Rao:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave rollowed your end 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 mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providers 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 1/2 ), is and be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Maria Rao
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a subscribe only in the requirements of the Act
that FDA has made a determination that your device and other requirements. You must that FDA has made a determination inal your diviser of other Federal agencies. You must
or any Federal statutes and regulations administered by one limited to: registration or any Federal statutes and regulations administered by registration and listing (21
comply with all the Act's requirements, including, but not ice registration and isting (2 comply with all the Act's requirements, including, out its arequirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Patt 801); good manufacture, prix familicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 ftPR 1000 forth in the quality systems (QS) regulation (21 OF RT Carver, 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
I has begally and the first of a line of a leater tal equivalence of your device This letter will allow you to begin market as uses as assesses of your device to a legally
premarket notification. The FDA finding of substantial equive and this nermits yo premarket notification. The PDA Induig of substantal equivation on thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CPR Part 801 and If you desire specific advice for your device on on stice devices), please contact the Office of
additionally 21 CFR Part 809.10 for in the same services on the remomotion an additionally 21 CFR Part 809.10 for mile unserver constion and advertising of
Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4613. Additionally, for questics of 994-4639. Also, please note the your device, please contact the Office of Companse and ification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premise at may be obtained from the regulation entitled, "Misoranding by receited or pronder the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number Division of Small 11001) 443-6597 or at its Internet address (800) 056-2014 11:12:14 gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patacio Cucenite /fo
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Sterngold Sterngold
510(k) Premarket Notification - Abbreviated
of Page
510(k) Number (if known): K021367
Device Name: Sterngold 66
Indications for Use:
Precious Alloy for use in Crown and Bridge Dental Restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the -Counter Use
Sven Rump
(Division Sign-Off) (Division Sign-Only)
Division of Dental, Infection Control, Division of Dentrol, رائيري والعمل المعادل المعمل مع . Kumber -