(202 days)
Filling material as a treatment for dental caries
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.
The provided text describes a 510(k) summary for several dental amalgam devices, asserting their substantial equivalence to a predicate device. This submission focuses on comparing the physical and chemical properties of the devices to establish this equivalence, rather than on the performance of an AI-powered diagnostic device.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable to this document as it does not describe a study involving an AI-powered diagnostic device that requires such metrics for validation.
Here's the information that can be extracted relevant to acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance:
| Product Characteristic | Acceptance Criteria (from ISO 24234) | Subject Devices Performance (Reported as complying) | Predicate Device Performance | Difference & Remarks |
|---|---|---|---|---|
| Chemical Composition | ||||
| Silver (Ag) (CAS 7440-22-4) | ≥ 40% | a) 44.5%; b) 70% | 56% | Compositions meet the requirements of ISO 24234. |
| Tin (Sn) (CAS 7440-31-5) | ≤ 32% | a) 30%; b) 18% | 27.9% | Compositions meet the requirements of ISO 24234. |
| Copper (Cu) (CAS 7440-50-8) | ≤ 30% | a) 25.5%; b) 12% | 15.4% | Compositions meet the requirements of ISO 24234. |
| Zinc (Zn) | ≤ 2% | Not explicitly stated, but implied to meet criteria | 0.2% | Compositions meet the requirements of ISO 24234. |
| Alloy-mercury Ratio | Not explicitly stated as a single criterion, but values provided | 1:1 (Mercury 50%) | Varies between 1/0.86 and 1/0.96 (46.2% to 49.5% by weight mercury) | Compositions meet the requirements of ISO 24234. |
| Physical Properties | ||||
| Particle shape & size | Not specified by a standard | 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; depends on product characteristics. Amalgams made from lathe-cut powders or admixed powders tend to resist condensation better. |
| Compressive strength @ 1hr | > 100 MPa | 171 MPa | 260 MPa | Data received is similar and products tested per ISO 24234. All results are within specifications and provide good performance of restoration. |
| Compressive strength @ 24hr | > 350 MPa | 443 MPa | 500 MPa | Data received is similar and products tested per ISO 24234. All results are within specifications and provide good performance of restoration. |
| Working times (minutes) - Condense | Not explicitly a criterion | 2.5 - 5 | 2.5 - 5 | No significant difference. |
| Working times (minutes) - Carving | Not explicitly a criterion | 4.5 - 7 | 5.5 - 7 | No significant difference. |
| Corrosion products (μg/cm²) | Not explicitly a criterion | 2 | 2.5 | No significant difference. |
| Ions leached and mercury vapor released during corrosion (ng/cm² in 4 hrs) | Not explicitly a criterion | < 65 | < 65 | No significant difference. |
| Creep | Max. 2% | 0.5% | 0.2% | All values are well within the maximum 2% criterion. |
| Dimensional change | -0.10 to +0.15 | 0.1 | -0.04% | All values are within the specified range. |
| Trituration time (seconds) High speed Amalgamator for capsule form | Not explicitly a criterion | 4-8 | 6 - 8 | Trituration time depends on spill size, variations in amalgamator. Does not affect safety and effectiveness. |
| Presentation forms | Not explicitly a criterion | Capsules: 1, 2 and 3 spill | Capsules: 1, 2, 3 & 5 spill | Difference in available spill sizes, but does not impact safety or effectiveness of the material itself. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in terms of distinct numerical values (e.g., number of amalgam samples tested for each property). The testing was completed in accordance with ISO 24234, which would specify sample size requirements for each test.
- Data Provenance: Not explicitly stated. The submitter is World Work Srl from Italy, so the testing was likely conducted in Europe or by contractors for the Italian company. The document does not indicate if it was retrospective or prospective.
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. This is a material science characterization, not a diagnostic study requiring expert ground truth establishment in the clinical sense. The "ground truth" here is the adherence to established international standards (ISO 24234) and their specified test methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The evaluation is based on compliance with a standard (ISO 24234), not on human interpretation or adjudication of diagnostic findings.
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 is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the device's performance is adherence to the physical and chemical property specifications set forth by ISO 24234. This standard provides the benchmark against which the device's characteristics are measured.
8. The sample size for the training set
- Not applicable. This is not an AI-powered device that undergoes a training phase.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI-powered device that undergoes a training phase.
Study Description (Summary of the "study" conducted):
The "study" conducted for these dental amalgam devices was non-clinical performance testing according to ISO 24234. The purpose was to demonstrate that the physical and mechanical properties of the subject devices meet the requirements of this international standard.
The tests carried out included:
- 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 from these tests, the manufacturer concluded that the subject devices are substantially equivalent to the predicate device (Permite Dental Amalgam Alloy K801639) by demonstrating compliance with the ISO 24234 standard.
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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 (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
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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 SrlContact person: Daniela Baldisserae-mail: quality@worldwork.it |
|---|---|
| Submitter of 510(k): | World Work SrlVia del Progresso, 47-36054 Montebello Vicentino (VI). ItalyTel: +39 0444 574297Fax: +39 0444 370543 |
| Date of Summary: | 17th April 2023 |
| Trade/Proprietary Name | Subject DevicesArial Dental, Mistral Dental AmalgamWorld Work Dental Amalgam, Flexi Alloy, Hi-S Alloy,BMS Non Gamma 2 Alloy, WW Dental Amalgam,Hi - Mix, Non Gamma 2 Alloy |
| Common/Usual NameProduct CodeRegulation | Alloy AmalgamEJJ21 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 severalother metals, used by dentists to make fillings for toothcavities. Amalgam alloys have been the most commonly useddirect restorative filling material for over a 100 years.Note: Class II Special Controls Guidance Document: DentalAmalgam, Mercury, and Amalgam Alloy - Guidance forIndustry and FDA Staff was used. |
| Predicate Device: | K801639 Permite Dental Amalgam Alloy |
| Substantial Equivalence: | The abovementioned subject devices are substantiallyequivalent in intended use and technological characteristicsto Permite (K801639, SOUTHERN DENTAL INDUSTRIES., INC.)Any difference that exists between our subject devices andthe predicate device has no negative effect on safety oreffectiveness. |
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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 | Acceptancecriteria | 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 treatmentfor dental caries | None. All products are intendedto be used as a filling material inrestorative dentistry | |
| Chemical Composition | ||||
| AlloySilver (Ag)CAS 7440-22-4Tin (Sn)CAS 7440-31-5Copper(Cu)CAS 7440-50-8Alloy-mercury Ratio | Ag ≥ 40Sn ≤ 32Cu ≤ 30Zn ≤ 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 thecomposition. (High silver and low silver content)1:1 (Mercury 50%) | Ag 56%, Sn 27.9%, Cu 15.4% In0.5%, Zn 0.2%The alloy to mercuryratio varies between 1/0.86and depending on the size and1/0.96 setting timei.e. 46.2% to 49.5% by weight.mercury | Compositions meet therequirements of ISO 24234 |
| Physical Properties | ||||
| Particle shape & size | Admix - spherical and lathe cut15 μm - 35 μm. | Admix - spherical and lathe cut15 μm - 35 μm | This parameter is not specifiedby a technical standard, itdepends on the characteristicsof the product. Amalgams madefrom lathe-cut powders oradmixed powders tend to resist | |
| condensation better thanamalgams made entirely fromspherical 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 withinspecifications and provide goodperformance of restoration. |
| Working times (minutes) | Condense: 2.5 - 5Carving: 4.5 - 7 | Condense: 2.5 - 5Carving: 5.5 - 7 | ||
| Corrosion productsions leached and mercuryvapor released duringcorrosion (ng/cm2 in 4 hrs) | 2 (μg/cm2)< 65ng/cm2 | 2.5 (μg/cm2)< 65ng/cm2 | ||
| Creep | Max. 2% | 0.5% | 0.2% | |
| Dimensional change | -0,10 to+0,15 | 0.1 | -0.04% | |
| Trituration time(seconds) High speedAmalgamator for capsuleform. | 4-8 | 6 - 8 | Trituration time depends on spillsize, variations in amalgamatorused (type, age, line voltage).This however does not affectthe safety and effectiveness ofthe 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 otherregions for over 15 years . The subject devices have shown clinicaleffectiveness and safety as well as stability under defined storageconditions. The components are same as those used in predicatedevice and other legally marketed dental amalgams.Dental Amalgam alloys are not sterile products |
|---|---|
| Performance NonClinical Testing | Performance testing was completed in accordance to ISO 24234 asrecommended in the FDA Guidance Document "Class II SpecialControls Guidance Document: Dental Amalgam, Mercury, andAmalgam Alloy - Guidance for Industry and FDA Staff .The testing was performed to show that the physical & mechanicalproperties of subject devices meet requirements .The list of tests carried out are:Package & Capsule contaminationChemical composition and purity of the dental amalgam alloyLarge particles in the dental amalgam alloy powderLoss of mass from the capsule during mixingYield of amalgam from the capsuleConsistency of the dental amalgam from capsule to capsulePhysical properties (Creep, dimensional change, compressivestrength, corrosion)Based on the data received from testing, we conclude that thesubject devices are substancially equivalent to Permite DentalAmalgam Alloy (K801639, Southern Dental Industries inc.) |
| Biocompatibility | A biocompatibility report has been submitted including rationalefor end points chosen |
| Risk | Currently the FDA recommends that high-risk populations as listedbelow avoid dental amalgam, if possible and appropriate.Children, especially those younger than sixPeople with neurological impairment or kidney dysfunctionPeople who are sensitive to mercury, silver, copper, tin, or zincNursing mothersWomen 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
§ 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.