(202 days)
Not Found
No
The device description and performance testing focus solely on the physical and chemical properties of a traditional dental amalgam alloy, with no mention of AI or ML.
Yes
The device is a filling material used to treat dental caries, which is a medical condition. Therefore, it is a therapeutic device.
No
The device is a filling material (dental amalgam alloy) used for treating dental caries, not for diagnosing conditions. Its primary function is therapeutic, not diagnostic.
No
The device description clearly states it is a mixture (alloy) of silver and other metals, which is a physical material used for dental fillings. The performance testing focuses on physical and mechanical properties, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Filling material as a treatment for dental caries." This describes a material used directly in the body for a therapeutic purpose (filling cavities), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description clearly states it's a "mixture (alloy) of silver and several other metals, used by dentists to make fillings for tooth cavities." This is a physical material for restoration, not a diagnostic test.
- Lack of Diagnostic Function: The description and performance testing focus on the physical and mechanical properties of the material (strength, creep, dimensional change, corrosion). There is no mention of analyzing a biological sample or providing information for diagnosis.
- Anatomical Site: The anatomical site is "Tooth cavities," which is where the material is placed, not where a sample would be taken for an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Filling material as a treatment for dental caries
Product codes (comma separated list FDA assigned to the subject device)
OIV, EJJ
Device Description
The subject devices are a mixture (alloy) of silver and several other metals, used by dentists to make fillings for tooth cavities. Amalgam alloys have been the most commonly used direct restorative filling material for over a 100 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
Performance testing was completed in accordance to ISO 24234 as recommended in the FDA Guidance Document "Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff . The testing was performed to show that the physical & mechanical properties of subject devices meet requirements. The list of tests carried out are: Package & Capsule contamination, Chemical composition and purity of the dental amalgam alloy, Large particles in the dental amalgam alloy powder, Loss of mass from the capsule during mixing, Yield of amalgam from the capsule, Consistency of the dental amalgam from capsule to capsule, Physical properties (Creep, dimensional change, compressive strength, corrosion). Based on the data received from testing, we conclude that the subject devices are substancially equivalent to Permite Dental Amalgam Alloy (K801639, Southern Dental Industries inc.)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Compressive strength @ 1hr: 171 MPa (> 100)
Compressive strength @ 24hr: 443 MPa (> 350)
Corrosion products: 2 (ug/cm2)
Ions leached and mercury vapor released during corrosion (ng/cm2 in 4 hrs):
§ 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.
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May 1, 2023
WorldWork S.R.L Daniela Baldissera Consultant Via Del Progresso, 47 Montebello, Vicentino 36054 ITALY
Re: K223182
Trade/Device Name: Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy Regulation Number: 21 CFR 872.3070 Regulation Name: Dental Amalgam, Mercury, And Amalgam Alloy Regulatory Class: Class II Product Code: OIV, EJJ Dated: February 27, 2023 Received: March 6, 2023
Dear Daniela Baldissera:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223182
Device Name
Arial Dental , Mistral Dental Amalgam World Work Dental Amalgam, Flexi Alloy, Hi-S Alloy, BMS Non Gamma 2 Alloy, WW Dental Amalgam, Hi-Mix, Non Gamma 2 Alloy
Indications for Use (Describe) Filling material as a treatment for dental caries
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for World Work Dentistry Dedicated. The logo features a green circular emblem on the left, followed by the words "World Work" in a larger, green font. Below "World Work" is the phrase "Dentistry Dedicated" in a smaller, dark gray font. The overall design is clean and professional, conveying a sense of dedication to dentistry.
K223182 510(k) SUMMARY
| Regulatory Correspondent: | World Work Srl
Contact person: Daniela Baldissera
e-mail: quality@worldwork.it |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | World Work Srl
Via del Progresso, 47-36054 Montebello Vicentino (VI). Italy
Tel: +39 0444 574297
Fax: +39 0444 370543 |
| Date of Summary: | 17th April 2023 |
| Trade/Proprietary Name | Subject Devices
Arial Dental, Mistral Dental Amalgam
World Work Dental Amalgam, Flexi Alloy, Hi-S Alloy,
BMS Non Gamma 2 Alloy, WW Dental Amalgam,
Hi - Mix, Non Gamma 2 Alloy |
| Common/Usual Name
Product Code
Regulation | Alloy Amalgam
EJJ
21 CFR872.3070 |
| Classification name: | Alloy, Amalgam |
| Indications for Use: | Filling material as a treatment for dental caries |
| Device Description: | The subject devices are a mixture (alloy) of silver and several
other metals, used by dentists to make fillings for tooth
cavities. Amalgam alloys have been the most commonly used
direct restorative filling material for over a 100 years.
Note: Class II Special Controls Guidance Document: Dental
Amalgam, Mercury, and Amalgam Alloy - Guidance for
Industry and FDA Staff was used. |
| Predicate Device: | K801639 Permite Dental Amalgam Alloy |
| Substantial Equivalence: | The abovementioned subject devices are substantially
equivalent in intended use and technological characteristics
to Permite (K801639, SOUTHERN DENTAL INDUSTRIES., INC.)
Any difference that exists between our subject devices and
the predicate device has no negative effect on safety or
effectiveness. |
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Image /page/4/Picture/0 description: The image shows the logo for World Work Dentistry Dedicated. The logo features a green circular emblem on the left, with a stylized "W" shape inside. To the right of the emblem, the words "World Work" are written in a sans-serif font, with "DENTISTRY DEDICATED" in smaller letters below.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Product name | Acceptance
criteria | Subject Devices | Predicate Device | Differences & Remarks |
|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ISO 24234 | Arial Dental , Mistral Dental Amalgam | Permite Dental Amalgam Alloy | |
| Characteristics | | World Work Dental Amalgam, BMS Non Gamma 2 Alloy,
Flexi Alloy, Hi-S Alloy, | | |
| | | WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy | | |
| 510K | | K223182 | K801639 | |
| Intended use: | | Filling material as a treatment for dental caries | Filling material as a treatment
for dental caries | None. All products are intended
to be used as a filling material in
restorative dentistry |
| Chemical Composition | | | | |
| Alloy
Silver (Ag)
CAS 7440-22-4
Tin (Sn)
CAS 7440-31-5
Copper(Cu)
CAS 7440-50-8
Alloy-mercury Ratio | Ag ≥ 40
Sn ≤ 32
Cu ≤ 30
Zn ≤ 2 | Each of the devices is available in 2 composition types
(indicated in label)
a) Ag 44,5% Sn 30% Cu 25,5%
b) Ag70% Sn18% Cu12%
The difference between the devices is only in the
composition. (High silver and low silver content)
1:1 (Mercury 50%) | Ag 56%, Sn 27.9%, Cu 15.4% In
0.5%, Zn 0.2%
The alloy to mercury
ratio varies between 1/0.86
and depending on the size and
1/0.96 setting time
i.e. 46.2% to 49.5% by weight
.mercury | Compositions meet the
requirements of ISO 24234 |
| Physical Properties | | | | |
| Particle shape & size | | Admix - spherical and lathe cut
15 μm - 35 μm. | Admix - spherical and lathe cut
15 μm - 35 μm | This parameter is not specified
by a technical standard, it
depends on the characteristics
of the product. Amalgams made
from lathe-cut powders or
admixed powders tend to resist |
| | | | | condensation better than
amalgams made entirely from
spherical powders |
| Compressive strength @ 1hr | > 100 | 171 MPa | 260 MPa | Data received is similar and |
| Compressive strength @ 24hr | > 350 | 443 MPa | 500 MPa | products tested per ISO 24234.
All results are within
specifications and provide good
performance of restoration. |
| Working times (minutes) | | Condense: 2.5 - 5
Carving: 4.5 - 7 | Condense: 2.5 - 5
Carving: 5.5 - 7 | |
| Corrosion products
ions leached and mercury
vapor released during
corrosion (ng/cm2 in 4 hrs) | | 2 (μg/cm2)
Via del Progresso, 47 - 36054 Montebello Vicentino (VI) – Italy Tel. + 39 0444 574297 - Fax. + 39 0444 370543 www.worldwork.it
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Image /page/5/Picture/0 description: The image shows the logo for World Work Dentistry Dedicated. The logo features a green abstract symbol on the left, followed by the words "World Work" in a larger, green font. Below "World Work" is the text "DENTISTRY DEDICATED" in a smaller, gray font. The overall design is clean and professional, suggesting a focus on dental care and commitment.
510k Summary
rev3
17.04.2023
page 3
Via del Progresso, 47 - 36054 Montebello Vicentino (VI) – Italy Tel. + 39 0444 574297 - Fax. + 39 0444 370543 www.worldwork.it
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Image /page/6/Picture/0 description: The image shows the logo for World Work Dentistry Dedicated. The logo features a green circular graphic on the left side, with a stylized "W" shape inside. To the right of the graphic, the words "World Work" are written in a sans-serif font, with the words "Dentistry Dedicated" written in a smaller font below.
| Sterilization & Shelf life | World Work Srl dental amalgams have been marketed in other
regions for over 15 years . The subject devices have shown clinical
effectiveness and safety as well as stability under defined storage
conditions. The components are same as those used in predicate
device and other legally marketed dental amalgams.
Dental Amalgam alloys are not sterile products |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Non
Clinical Testing | Performance testing was completed in accordance to ISO 24234 as
recommended in the FDA Guidance Document "Class II Special
Controls Guidance Document: Dental Amalgam, Mercury, and
Amalgam Alloy - Guidance for Industry and FDA Staff .
The testing was performed to show that the physical & mechanical
properties of subject devices meet requirements .
The list of tests carried out are:
Package & Capsule contamination
Chemical composition and purity of the dental amalgam alloy
Large particles in the dental amalgam alloy powder
Loss of mass from the capsule during mixing
Yield of amalgam from the capsule
Consistency of the dental amalgam from capsule to capsule
Physical properties (Creep, dimensional change, compressive
strength, corrosion)
Based on the data received from testing, we conclude that the
subject devices are substancially equivalent to Permite Dental
Amalgam Alloy (K801639, Southern Dental Industries inc.) |
| Biocompatibility | A biocompatibility report has been submitted including rationale
for end points chosen |
| Risk | Currently the FDA recommends that high-risk populations as listed
below avoid dental amalgam, if possible and appropriate.
Children, especially those younger than six
People with neurological impairment or kidney dysfunction
People who are sensitive to mercury, silver, copper, tin, or zinc
Nursing mothers
Women who are pregnant or planning to become pregnant |
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, World Work SRL concludes that the subject devices:
Arial Dental, Mistral Dental Amalgam , World Work Dental Amalgam, Flexi Alloy, Hi-S Alloy, BMS Non Gamma 2 Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy
Are safe, effective and substantially equivalent to the predicate device as described herein. They do not introduce new indications for use, have similar technological characteristics and do not introduce new potential hazards or risks.
510k Summary rev3 17.04.2023 page 4 Via del Progresso, 47 - 36054 Montebello Vicentino (VI) - Italy Tel. + 39 0444 574297 - Fax. + 39 0444 370543 www.worldwork.it