(63 days)
Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets, intended to be combined with amalgam alloy for the direct filling of carious lesions or structural defects in teeth.
Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets.
The provided document (K093587) describes a 510(k) submission for "Dental Mercury," an elemental mercury product used in dental amalgam. This submission is an Abbreviated 510(k), which means it demonstrates substantial equivalence to a predicate device by showing conformity to recognized consensus standards and FDA guidance documents, rather than through a traditional clinical study with detailed performance metrics.
Therefore, the information requested in the prompt, which typically pertains to the performance evaluation of a device through a study with specific acceptance criteria, test sets, ground truth establishment, and statistical analysis, is not explicitly available or applicable in the provided document for "Dental Mercury" in the same way it would be for a diagnostic or AI-driven device.
Here's an attempt to address each point based on the information provided, highlighting the limitations due to the nature of an Abbreviated 510(k) for a material like elemental mercury:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for "Dental Mercury" are based on compliance with established standards and FDA guidance for this type of material, rather than performance metrics from a specific study.
| Acceptance Criteria (from recognized standards/guidance) | Reported Device Performance |
|---|---|
| ISO 24234:2004(E) Dentistry Mercury and alloys for dental amalgam First edition: Defines requirements for dental mercury and amalgam alloys. | The device meets the requirements included in ISO 24234:2004(E). This implies the elemental mercury supplied is of the quality, purity, and other specifications outlined in this standard for dental use. |
| Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff (July 28, 2009): Outlines specific controls to enhance the safety and effectiveness of dental amalgam, mercury, and amalgam alloy. | The device conforms to FDA's guidance document. This suggests compliance with recommended practices concerning manufacturing, labeling, biocompatibility considerations, and other aspects for dental mercury. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was an Abbreviated 510(k) based on compliance with existing standards and guidance, not a study involving a "test set" of patient data or clinical samples. The "device performance" is demonstrated through adherence to material specifications and regulatory controls.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As noted above, there was no "test set" requiring ground truth established by experts in the context of a clinical performance study. The "ground truth" for the acceptance of dental mercury is the established scientific and regulatory consensus on its material properties and safety when used as intended, as codified in ISO standards and FDA guidance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set or adjudication method for clinical performance. The "adjudication" in this context is the FDA's regulatory review process to confirm that the manufacturer's claims of conformity to the referenced standards and guidance are valid.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is elemental mercury for dental fillings, not an AI-driven or diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is elemental mercury, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth"
for this submission is the expert consensus and scientific understanding formalized in the referenced consensus standard (ISO 24234:2004(E)) and FDA guidance document ("Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy"), which define the acceptable characteristics and safe use of elemental mercury in dentistry.
8. The sample size for the training set
Not applicable. This submission is about a material (elemental mercury), not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set as this is not an AI/ML device.
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510(k) Summary
JAN 2 1 2010
ਸੰ
Trade Name:
Dental Mercurv
Sponsor:
9
DMG USA, Inc. 23 Frank Mossberg Drive Attleboro. MA 02703 Registration # not vet assigned Owner/Operator No. 9005969
| Subject Device: | |
|---|---|
| Device Name: | Dental Mercury |
| Classification/Regulation: | ELY - Dental Mercury |
| 21 CFR 872.3700; Class II |
Product Description
Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets.
Indications for Use:
Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets, intended to be combined with amalgam alloy for the direct filling of carious lesions or structural defects in teeth.
The proposed Dental Mercury meets the requirements included in the following consensus standards and FDA guidance documents:
-
- ISO 24234:2004(E) Dentistry Mercury and alloys for dental amalgam First edition
-
- Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff (July 28, 2009)
Predicate Devices:
The components of the proposed Dental Mercury are substantially equivalent to several currently marketed products including the following:
Dental Mercury:
| Product Name | Predicates |
|---|---|
| MERCURY DENTAL | K973548; ALEACIONES DENTALESZEYCO, S.A. DE C.V. |
| DENTAL-QUECKSILBER | K902388; DEGUSSA AG |
Safety and Performance:
This submission is an 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), DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled:
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Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff (July 2009)
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Dental Mercury has been shown to meet the requirements established in FDA's Class II Special Controls guidance document, and to be safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 1 2010
DMG USA, Incorporated C/O Ms. Pamela Papineau Consultant 23 Frank Mossberg Drive Attleboro, Massachuttes 02703
Re: K093587
Trade/Device Names: Dental Mercury Regulation Number: 21 CFR 872.3700 Regulation Name: Dental Amalgam, Mercury, and Amalgam Allov Regulatory Class: II Product Code: ELY Dated: November 18, 2009 Received: November 19, 2009
Dear Ms. Papineau:
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 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.
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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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
fur.
Anthony D. Watson, B.S., M.S., M.B.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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Page __ 1__ of _______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K093587
Device Name: Dental Mercury
Indications for Use:
Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets, intended to be combined with amalgam alloy for the direct filling of carious lesions or structural defects in teeth.
| Prescription Use X | OR | Over-the-Counter Use ___ |
|---|---|---|
| (Per 21 CFR 801 Subpart D) | (Per 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RsBetz DS for Dr R. Mury (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K093587
§ 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.