(63 days)
Not Found
No
The device is elemental mercury for dental fillings, with no mention of software, image processing, or AI/ML terms.
No
This device is elemental mercury, which is a material used in a dental procedure (filling carious lesions), but it does not directly provide a therapeutic effect itself. It is a component that facilitates the restoration of tooth structure, rather than actively treating a disease or condition.
No
Explanation: This device is elemental mercury used for dental fillings, which is a treatment material, not a diagnostic tool.
No
The device description clearly states it is elemental mercury supplied as a liquid, which is a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to be combined with amalgam alloy for direct filling of teeth. It is applied to the body, not used to test samples from the body.
- The description clearly states its purpose is for dental fillings. This is a therapeutic and restorative use, not a diagnostic one.
The information provided confirms it's a dental material used in a clinical procedure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / 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.
Product codes
ELY
Device Description
Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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: Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff (July 2009).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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 DENTALES |
| ZEYCO, 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:
1
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.
2
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.
3
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