(55 days)
Jensen Gold Foil is pure gold direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations.
Jensen Gold Foil is pure gold, direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations, Indications for use and chemical composition are identical to those of the predicate devices.
This document describes a medical device submission (K022206) for "Jensen Gold Foil," a pure gold direct filling gold foil used by dentists for various dental preparations. The submission is a 510(k) summary, indicating that the device is seeking clearance based on substantial equivalence to predicate devices, rather than requiring extensive new clinical trials.
Therefore, the customary information about acceptance criteria and a study proving device performance (as would be typical for software or complex medical devices with performance metrics like sensitivity/specificity) is not applicable in this context.
Here's why and what information is provided:
1. Acceptance Criteria and Reported Device Performance:
- Not Applicable. The submission states, "There are no standards for direct filling gold foil." Therefore, there are no specific numerical acceptance criteria like sensitivity, specificity, accuracy, or F1-score that would be applicable to AI or diagnostic devices.
- Reported Device Performance: Instead of numerical performance metrics, the "performance" of Jensen Gold Foil is based on its long-standing history of clinical use and material properties. The submission refers to:
- "centuries long clinical success of direct filling gold foil."
- "Gold foil is the reference standard for biocompatibility and longevity."
- A citation from "Skinner's Science of Dental Materials" states, "there can be no doubt that a properly inserted direct gold restoration is unsurpassed from the standpoint of service."
2. Sample Size for Test Set and Data Provenance:
- Not Applicable. There was no formal "test set" or clinical study with a specific sample size conducted for this 510(k) submission. The clearance is based on substantial equivalence to existing devices and the historical clinical performance of the material itself.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. No ground truth was established by experts for a specific test set. The efficacy and safety are inferred from the general understanding and historical use of gold foil in dentistry, as supported by dental literature.
4. Adjudication Method:
- Not Applicable. No adjudication method was used as there was no test set requiring ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This is a material device, not a diagnostic or AI-powered system designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. Standalone Performance Study:
- Not Applicable. This device does not have a "standalone algorithm only" performance as it is a physical dental filling material, not software.
7. Type of Ground Truth Used:
- Historical Clinical Consensus / Textbook Reference. The "ground truth" for the safety and effectiveness of Jensen Gold Foil is derived from:
- The "centuries long clinical success" of direct filling gold foil.
- Its status as the "reference standard for biocompatibility and longevity."
- Evidence cited from "Skinner's Science of Dental Materials," a fundamental textbook in dental materials.
8. Sample Size for the Training Set:
- Not Applicable. There was no "training set" in the context of an algorithm or AI model development. The manufacturing processes and material composition would be based on established dental metallurgy and quality control, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there was no training set, this question is not relevant. The "ground truth" regarding the material's properties and manufacturing would adhere to established scientific principles and industry standards for dental materials.
In summary: The Jensen Gold Foil 510(k) submission relies on the established safety and efficacy of direct filling gold foil as a known dental material, rather than presenting a new study with specific performance metrics and acceptance criteria. The FDA's clearance is based on its substantial equivalence to predicate devices and the long clinical history of the material itself.
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Section E
510(k) SUMMARY
Kozadol
Jensen Industries Submitted by: 50 Stillman Road North Haven CT 06473 (203) 239-2090 phone (203) 239-1015 fax Contact: John Slanski
June 25, 2002 Date Prepared:
Device Name: Common Name: Classification: Product Code:
Jensen Gold Foil Direct filling gold foil Class II EJT
Predicate Device(s):
EZ Gold - K915626 Williams Gold Foil (pre-amendment device)
Device Description:
Jensen Gold Foil is pure gold, direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations, Indications for use and chemical composition are identical to those of the predicate devices.
There are no standards for direct filling gold foil. The safety and effectiveness of Jensen Gold Foil is based upon the centuries long clinical success of direct filling gold foil. Gold foil is the reference standard for biocompatibility and longevity. In the hands of a skilled operator, "there can be no doubt that a properly inserted direct gold restoration is unsurpassed from the standpoint of service."1
1 Phillips R.W. Skinner's Science of Dental Materials. 8th ed. Philadelphia: WB Saunders, 1982:366.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's wings are represented by curved lines that also form the profiles of three faces.
AUG 2 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Slanksi Manager, Research & Development Jensen Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473
Re: K022206
Trade/Device Name: Jensen Gold Foil Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: June 25, 2002 Received: July 05, 2002
Dear Mr. Slanksi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 – Mr. Slanksi
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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
Timothy A. Ulatowski
Timoth v A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
.. . . .
Ver/ 3 - 4/24/96
| Applicant: | Jensen Industries Incorporated |
|---|---|
| 510(k) Number (if known): | K022206 |
| Device Name: | Jensen Gold Foil |
| Indications For Use: | Jensen Gold Foil is pure gold direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
| 510(k) Number: | K022206 |
|---|---|
| ---------------- | --------- |
{Ref DCF 2721}
§ 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.