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

K223182 · Worldwork S.R.L · OIV · May 1, 2023 · Dental

Device Facts

• Record ID: K223182
• 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
• Applicant: Worldwork S.R.L
• Product Code: OIV · Dental
• Decision Date: May 1, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Filling material as a treatment for dental caries

Device Story

Dental amalgam alloy mixture of silver, tin, copper, and zinc; used by dentists as direct restorative filling material for tooth cavities. Supplied in capsule form for trituration in high-speed amalgamators. Device transforms alloy powder and mercury into a restorative material. Used in clinical dental settings by licensed practitioners. Output is a hardened filling material that restores tooth structure affected by caries. Benefits include long-term clinical effectiveness and stability in dental restorations.

Clinical Evidence

Bench testing only. Performance testing conducted per ISO 24234 and FDA Class II Special Controls Guidance. Tests included chemical composition, purity, particle size, capsule contamination, mass loss, yield, consistency, creep, dimensional change, compressive strength, and corrosion. Biocompatibility report submitted with rationale for endpoints.

Technological Characteristics

Admix (spherical and lathe-cut) alloy powder (Ag, Sn, Cu, Zn) and mercury. Dimensions: 15-35 μm particle size. Energy source: external high-speed amalgamator. Presentation: 1, 2, and 3 spill capsules. Non-sterile. Complies with ISO 24234.

Indications for Use

Indicated for patients requiring treatment for dental caries. Contraindicated for children under six, individuals with neurological impairment or kidney dysfunction, those sensitive to mercury, silver, copper, tin, or zinc, nursing mothers, and women who are pregnant or planning to become pregnant.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Permite Dental Amalgam Alloy (K801639)

Submission Summary (Full Text)

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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.

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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 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 ([e-mail]) or phone [phone] 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

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# 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<br>Contact person: Daniela Baldissera<br>e-mail: [e-mail] |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | World Work Srl<br>Via del Progresso, 47-36054 Montebello Vicentino (VI). Italy<br>Tel: [phone]<br>Fax: [phone] |
| Date of Summary: | 17th April 2023 |
| Trade/Proprietary Name | Subject Devices<br>Arial Dental, Mistral Dental Amalgam<br>World Work Dental Amalgam, Flexi Alloy, Hi-S Alloy,<br>BMS Non Gamma 2 Alloy, WW Dental Amalgam,<br>Hi - Mix, Non Gamma 2 Alloy |
| Common/Usual Name<br>Product Code<br>Regulation | Alloy Amalgam<br>EJJ<br>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<br>other metals, used by dentists to make fillings for tooth<br>cavities. Amalgam alloys have been the most commonly used<br>direct restorative filling material for over a 100 years.<br>Note: Class II Special Controls Guidance Document: Dental<br>Amalgam, Mercury, and Amalgam Alloy - Guidance for<br>Industry and FDA Staff was used. |
| Predicate Device: | K801639 Permite Dental Amalgam Alloy |
| Substantial Equivalence: | The abovementioned subject devices are substantially<br>equivalent in intended use and technological characteristics<br>to Permite (K801639, SOUTHERN DENTAL INDUSTRIES., INC.)<br>Any difference that exists between our subject devices and<br>the predicate device has no negative effect on safety or<br>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<br>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,<br>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<br>for dental caries | None. All products are intended<br>to be used as a filling material in<br>restorative dentistry |
| Chemical Composition | | | | |
| Alloy<br>Silver (Ag)<br>CAS 7440-22-4<br>Tin (Sn)<br>CAS 7440-31-5<br>Copper(Cu)<br>CAS 7440-50-8<br>Alloy-mercury Ratio | Ag ≥ 40<br>Sn ≤ 32<br>Cu ≤ 30<br>Zn ≤ 2 | Each of the devices is available in 2 composition types<br>(indicated in label)<br><br>a) Ag 44,5% Sn 30% Cu 25,5%<br><br>b) Ag70% Sn18% Cu12%<br><br>The difference between the devices is only in the<br>composition. (High silver and low silver content)<br><br>1:1 (Mercury 50%) | Ag 56%, Sn 27.9%, Cu 15.4% In<br>0.5%, Zn 0.2%<br><br>The alloy to mercury<br>ratio varies between 1/0.86<br>and depending on the size and<br>1/0.96 setting time<br>i.e. 46.2% to 49.5% by weight<br>.mercury | Compositions meet the<br>requirements of ISO 24234 |
| Physical Properties | | | | |
| Particle shape & size | | Admix - spherical and lathe cut<br>15 μm - 35 μm. | Admix - spherical and lathe cut<br>15 μm - 35 μm | This parameter is not specified<br>by a technical standard, it<br>depends on the characteristics<br>of the product. Amalgams made<br>from lathe-cut powders or<br>admixed powders tend to resist |
| | | | | condensation better than<br>amalgams made entirely from<br>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.<br>All results are within<br>specifications and provide good<br>performance of restoration. |
| Working times (minutes) | | Condense: 2.5 - 5<br>Carving: 4.5 - 7 | Condense: 2.5 - 5<br>Carving: 5.5 - 7 | |
| Corrosion products<br>ions leached and mercury<br>vapor released during<br>corrosion (ng/cm2 in 4 hrs) | | 2 (μg/cm2)<br>< 65ng/cm2 | 2.5 (μg/cm2)<br>< 65ng/cm2 | |
| Creep | Max. 2% | 0.5% | 0.2% | |
| Dimensional change | -0,10 to<br>+0,15 | 0.1 | -0.04% | |
| Trituration time<br>(seconds) High speed<br>Amalgamator for capsule<br>form. | | 4-8 | 6 - 8 | Trituration time depends on spill<br>size, variations in amalgamator<br>used (type, age, line voltage).<br>This however does not affect<br>the safety and effectiveness of<br>the products. |
| Presentation forms | | Capsules: 1,2 and 3 spill | Capsules: 1,2 ,3 & 5 spill | |

510k Summary rev3 17.04.2023 page 2

> 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<br>regions for over 15 years . The subject devices have shown clinical<br>effectiveness and safety as well as stability under defined storage<br>conditions. The components are same as those used in predicate<br>device and other legally marketed dental amalgams.<br><br>Dental Amalgam alloys are not sterile products |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Non<br>Clinical Testing | Performance testing was completed in accordance to ISO 24234 as<br>recommended in the FDA Guidance Document "Class II Special<br>Controls Guidance Document: Dental Amalgam, Mercury, and<br>Amalgam Alloy - Guidance for Industry and FDA Staff .<br>The testing was performed to show that the physical & mechanical<br>properties of subject devices meet requirements .<br>The list of tests carried out are:<br>Package & Capsule contamination<br>Chemical composition and purity of the dental amalgam alloy<br>Large particles in the dental amalgam alloy powder<br>Loss of mass from the capsule during mixing<br>Yield of amalgam from the capsule<br>Consistency of the dental amalgam from capsule to capsule<br>Physical properties (Creep, dimensional change, compressive<br>strength, corrosion)<br>Based on the data received from testing, we conclude that the<br>subject devices are substancially equivalent to Permite Dental<br>Amalgam Alloy (K801639, Southern Dental Industries inc.) |
| Biocompatibility | A biocompatibility report has been submitted including rationale<br>for end points chosen |
| Risk | Currently the FDA recommends that high-risk populations as listed<br>below avoid dental amalgam, if possible and appropriate.<br>Children, especially those younger than six<br>People with neurological impairment or kidney dysfunction<br>People who are sensitive to mercury, silver, copper, tin, or zinc<br>Nursing mothers<br>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