(128 days)
DD base P HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. DD base P HI is suitable for long-term use in the oral cavity up to 10 years.
DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite requlators for long-term application in the oral cavity up to 12 months.
DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems.
The provided text is a 510(k) Summary for a medical device (DD medical polymers (PMMA)). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data in the format of a clinical or analytical study.
Therefore, the requested information cannot be fully extracted because the document is a regulatory submission for substantial equivalence based on in vitro testing and comparison to existing standards, not a standalone clinical or performance study with detailed acceptance criteria and expert reviews in the typical sense of a diagnostic device.
However, I can extract the relevant information regarding the tests performed to demonstrate substantial equivalence and what serves as the "acceptance criteria" in this context (meeting relevant standards).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria and device performance in a direct "acceptance criteria vs. reported performance" table format. Instead, it indicates that the device's physical properties "meet the requirements of the relevant standards ISO 20795-1 and ISO 20795-2 as well as the values of the Predicate Device / Reference Device." The table on pages 8-9 provides a comparison of physical characteristics between the new device, primary predicate device, and reference device. The "acceptance criteria" here are implicitly defined by the requirements of the standards and the performance of the predicate/reference devices.
Interpretation based on the provided table (pages 8-9) and text:
| Feature | Acceptance Criteria (based on standards/predicate) | Reported Device Performance (New Device) | Comment/Justification |
|---|---|---|---|
| Flexural strength | ≥ 75 MPa (Predicate) / 90 MPa (Reference) | ≥ 64 MPa | Comparable (meets standards ISO 20795-1 / ISO 20795-2, see discussion on page 11) |
| Flexural modulus | 2800 (± 200) MPa (Predicate) | ≤ 2030 MPa | Comparable (meets standards ISO 20795-1 / ISO 20795-2, see discussion on page 11) |
| Water absorption | ≤ 23 µg/mm³ (Predicate) / < 23 µg/mm³ (Reference) | < 24 µg/mm³ | Comparable (meets standards ISO 20795-1 / ISO 20795-2, see discussion on page 11) |
| Solubility | 0.2 µg/mm³ (Predicate) / < 0.0 µg/mm³ (Reference) | < 0.3 µg/mm³ | Comparable (meets standards ISO 20795-1 / ISO 20795-2, see discussion on page 11) |
| Residual monomer content | 0.4 % (Predicate) / < 1.4 % (Reference) | < 0.7 % | Comparable (meets standards ISO 20795-1 / ISO 20795-2, see discussion on page 11) |
| Stress intensity factor | Not stated in 510(k) submission (Predicate/Reference) | ≥ 2.4 MPa*m^1/2^ (DD base P HI) | See discussion (raw material is same, values comply with relevant standards and FDA Guidance, no increased risk) |
| Fracture work | Not stated in 510(k) submission (Predicate/Reference) | > 2200 J/m² (DD base P HI) | See discussion (raw material is same, values comply with relevant standards and FDA Guidance, no increased risk) |
| Biocompatibility | No cytotoxicity (EN ISO 10993-1, EN ISO 10993-5 standards) | Classified as eminently suitable | Tested by an accredited testing laboratory, results show no cytotoxical potential. |
| Application time | ≤ 12 months (DD Bio Splint P HI) / Not restricted (Reference for DD base P HI) | 12 months (DD Bio Splint P HI) / 10 years (DD base P HI) | Comparable (10 years is less risky than "not restricted" and supported by accelerated aging test, see discussion). |
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: The document does not specify the exact sample sizes used for each physical test. It only states that "Non-clinical testing was performed in order to validate the product against the company's specified design requirements."
- Data Provenance: The company, Dental Direkt GmbH, is located in Spenge, Germany. The testing was performed by "an accredited testing laboratory." The specifics of whether the data were retrospective or prospective are not mentioned, but in vitro physical and biocompatibility testing is typically prospective for new device submissions.
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)
This is not applicable. The tests performed are non-clinical (physical and biocompatibility) against established international standards (ISO 20795-1, ISO 20795-2, EN ISO 10993-1, EN ISO 10993-5). Ground truth is established by these standards' methodologies and acceptance criteria, not by expert consensus in clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as the document refers to non-clinical physical and biocompatibility testing not requiring adjudication involving expert readers.
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
This is not applicable. The device is a dental material (PMMA milling blanks) and not an AI-powered diagnostic device or an imaging product requiring human reader interpretation. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is a dental material and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on:
- Established international standards (ISO 20795-1, ISO 20795-2, EN ISO 10993-1, EN ISO 10993-5).
- The performance values of legally marketed predicate and reference devices.
- The company's specified design requirements validated by testing.
8. The sample size for the training set
This is not applicable, as this is a physical medical device (materials) and does not involve AI or algorithms that require a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Dental Direkt GmbH Patrick Berz Regulatory Affairs Manager Industriezentrum 106-108 Spenge, 32139 Germany
Re: K230410
Trade/Device Name: DD medical polymers (PMMA) Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, MQC Dated: May 25, 2023 Received: May 25, 2023
Dear Patrick Berz:
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.
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
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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.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
DD medical polymers (PMMA)
Indications for Use (Describe)
DD base P HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. DD base P HI is suitable for long-term use in the oral cavity up to 10 years.
DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite requlators for long-term application in the oral cavity up to 12 months.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
as required by 21 CFR 807.92(c)
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510(k) Number: K230410
Date:
2023/05/25
510(k) Summary
-
Submitter of 510(k)
-
Dental Direkt GmbH Industriezentrum 106-108 32139 Spenge / Germany
-
Contact Person
-
Patrick Berz, Manager Regulatory Affairs Phone:+49 5225 86319-0 Fax: +49 5225 86319-99 p.berz@dentaldirekt.de
-
Establishment Registration No. 3008347275 2023/05/25 Date Prepared Trade Name of Device DD medical polymers (PMMA)
-
Classification Product Code EBI
Subsequent Product Codes
- Common Name Resin, Denture, Relining, Repairing, Rebasing
Class II
MQC
- Regulation Number 21 CFR 872.3760
- Dental
- Classification
Panel
-
Primary Predicate Device
- Reference Device
Dental Direkt GmbH DD medical polymers K150432 Union Dental S.A. IDODENTINE DISC
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| Indications for Use | DD Bio Splint P HI are transparent dental milling blanks out ofPMMA for the manufacture of splints, therapeutic splints andbite regulators for long-term application in the oral cavity up to12 months.DD base P HI are pre-colored dental milling blanks made ofimpact-resistant PMMA for the manufacture of denture basesfor removable dentures. DD base P HI is suitable for long-term use in the oral cavity up to 10 years. |
|---|---|
| Device Description | DD medical polymers (PMMA), made from PMMA, areindustrially polymerized, pre-colored or clear dental millingblanks designed for milled fabrication of bite splints (clearvariant) or denture bases (gingiva-colored variants) on dentalCAD/CAM systems. |
| Technological Characteristics | The technological characteristics of the modifieddevice are comparable to the legally marketed device. Thephysical properties are not identical to the Predicate Devicebut can be considered as sufficient, since the values meet therequirements of the relevant standards ISO 20795-1 and ISO20795-2 as well as the values of the Predicate Device /Reference Device.All devices are made of PMMA, partly with small amounts ofcoloring pigments. |
| Material | PMMA |
| Discussion ofTests Performed | Clinical TestsDental Direkt GmbH did not conduct, nor rely upon, clinicaltests to determine substantial equivalence as dental polymersthat fall under the FDA product codes MQC and EBI have along history of safe and effective use in the US.Non Clinical TestsNon-clinical testing was performed in order to validate theproduct against the company's specified design requirementsaccording to the following standards:EN ISO 10993-1 (biological compatibility) and EN ISO 10993-5 (cytotoxicity)DD medical polymers (PMMA) were tested by an accreditedtesting laboratory with respect to biocompatibility. Based onthe test results DD medical polymers was classified aseminently suitable for use in the dental applications. |
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- ISO 20795-1, Dentistry Base polymers Part 1: Denture base polymers (FDA Recognition # 4-232)
- ISO 20795-2, Dentistry Base polymers Part 2: Orthodontic base polymers (FDA Recognition # 4-233)
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| Feature | New Device | Primary Predicate Device | Reference Device | Comment |
|---|---|---|---|---|
| Trade name | DD medical polymers(PMMA) | DD medical polymers | IDODENTINE DISC | n.a. |
| Included products | DD base P HIDD Bio Splint P HI | DD temp MEDDD Bio Splint P | n.a. | n.a. |
| 510(k) | K230410 | K153490 | K150432 | n.a. |
| Product codes | EBI (DD base P HI) | n.a. | EBI | Identical toReference Device |
| MQC (DD Bio Splint P HI) | MQC (DD Bio Splint P) | MQC | Identical | |
| n.a. | EBG (DD temp MED) | EBG | n.a. (Not part ofthis submission) | |
| Regulatory class | Class II | Class II | Class II | Identical |
| Manufacturer | Dental Direkt GmbH | Dental Direkt GmbH | Union Dental S.A. | n.a. |
| Intended use | DD base P HI are pre-colored dental millingblanks made of impact-resistant PMMA for themanufacture of denture bases for removabledentures. DD base P HI is suitable for long-term usein the oral cavity up to 10 years.DD Bio Splint P HI aretransparent dental millingblanks out of PMMA for themanufacture of splints,therapeutic splints and biteregulators for long-termapplication in the oralcavity up to 12 months. | DD medical polymers areindicated for temporary (≤ 12 months) crowns, bridgesand bite splints.Applications include bothanterior and posteriorstructures. | Acrylic polymer blankparticularly suitable formaking removable ortemporary dentalstructures such ascrowns and bridges usingmilling technology usingCAD/CAM.Indications:- Temporary anterior andposterior crowns- Temporary anterior andposterior bridges with upto two adjacent pontics- Implant supportedtemporary restorationsMaximum recommendedusage period: 12 months | DD Bio Splint P HI:Identical toPredicate DeviceDD base P HI:Identical toReference Device:- different wording,but identical (bothsuitable forremovable denturebases)- wording ofReference Deviceis much moregeneral (seediscussion) |
| Feature | New Device | Primary Predicate Device | Reference Device | Comment |
| - Removable structuresfor dentures (dentalbases)- Removable structuresfor therapeuticrestorations (bite splintsor occlusal splints) | ||||
| Max. application | 12 months (DD Bio SplintP HI) | 12 months | 12 months | Identical toPredicate Device |
| 10 years (DD base P HI) | Not restricted | Comparable toReference Device,see discussion | ||
| Technology | Blank for dental CAD/CAMmachining | Blank for dental CAD/CAMmachining | Blank for dentalCAD/CAM machining | Identical |
| Shape | Disc | Disc | Disc | Identical |
| Shade | clear, pink | VITA-shades, clear | VITA shades, clear, pink | Identical |
| Raw material | PMMA | PMMA | PMMA | Identical |
| Chemical composition [Units] | ||||
| Material base | > 99.0 [wt%] (Polymethylmethacrylate) | > 99.0 [wt%] (Polymethylmethacrylate) | Polymethyl methacrylate | Identical toPredicate Device |
| Coloring pigments | ≤ 1.0 [wt%] | ≤ 1.0 [wt%] | Not specified | Identical toPredicate Device |
| Feature | New Device | Primary Predicate Device | Reference Device | Comment |
| Physical characteristics [Units] | ||||
| Flexural strength | ≥ 64 MPa | ≥ 75 MPa | 90 MPa | Comparable (seediscussion) |
| Flexural modulus | ≤ 2030 MPa | 2800 (± 200) MPa | Not stated in 510(k)submission | Comparable (seediscussion) |
| Water absorbtion | < 24 µg/mm³ | ≤ 23 µg/mm³ | < 23 µg/mm³ | Comparable (seediscussion) |
| Solubility | < 0.3 µg/mm³ | 0.2 µg/mm³ | < 0.0 µg/mm³ | Comparable (seediscussion) |
| Residual monomercontent | < 0.7 % | 0.4 % | < 1.4 % | Comparable (seediscussion) |
| Stress intensityfactor | ≥ 2.4 MPa*m1/2 (DD baseP HI) | Not stated in 510(k)submission | Not stated in 510(k)submission | See discussion |
| Fracture work | > 2200 J/m² (DD base PHI) | Not stated in 510(k)submission | Not stated in 510(k)submission | See discussion |
| Physical testsaccording to: | ISO 10477 (only relevantexcerpts), ISO 20795-1,ISO 20795-2 | ISO 10477, ISO 20795-1 | ISO 10477, ISO 20795-1 | Comparable (seediscussion) |
| Biocompatibiltytests according to: | EN ISO 10993-1, -5 | EN ISO 10993-1, -5 | EN ISO 10993-1, -5 | Identical |
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Substantial Equivalence The goal of this submission is to add additional products to the already approved DD medical polymers Discussion / Conclusion product group.
The maximum application time, the product codes and the shade of DD Bio Splint P HI are the same compared to the Predicate Device. Only DD base P HI differs slightly from the Predicate Device. Therefore, the Reference Device was added to the table above.
While DD Bio Splint P HI represents a further development of the product DD Bio Splint P which is included in the Predicate Device, the product DD base P HI extends the field of application to denture bases. Therefore, the Intended Use was adjusted and a new product code (EBI) was added. The
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Intended Use of DD Bio Splint P HI is identical to the Intended Use of the Predicate Device, even though the wording is not exactly the same. This is because the Intended Use of the Predicate Device is more detailed compared to the general Intended Use of the Predicate Device.
The Intended Use of DD base P HI is identical to that of the Reference Device, even though there is a slightly different wording. The Intended Use of the Reference Device is much more general: however, the Intended Use of the Subject Device falls under the Intended Use of the Reference Device (both suitable for denture bases). The application time in the Intended Use of the Reference Device is not restricted, while Dental Direkt restricts the application time to 10 years. Since a longer application time leads to a higher risk, the application time of 10 years is less risky and therefore falls under the application time of the Reference Device.
Theoretically, the material is suitable for a longer application time; however Dental Direkt has conducted an accelerated aging test where over 10 years were simulated. Even after aging, no abnormalities were found in regard to biocompatibility. Nevertheless, Dental Direkt restricts the max. application time to 10 years.
Although the indication was extended to denture bases compared to the Predicate Device, this does not pose an increased risk because the existing indication with crowns and bridges is surgically invasive and therefore more risky than denture bases are only invasive, because they only lie on the oral mucosa.
Compared to the Predicate Device, new shades were added. The base material PMMA is the same for all products of DD medical polymers, only different amounts of coloring pigments were chosen to simulate the qinqival color. Biocompatibility tests according ISO 10993-1 and ISO 10993-5 were conducted and the results show no cytotoxical potential. The available shades are identical to those of the Reference Device and, in case of DD Bio Splint P HI, to those of the Predicate Device as well.
The physical properties are not fully identical to those of the Predicate Device, but can be considered as comparable. In case of stress intensity factor and fracture work, both are not mentioned in the Predicate Device / Reference Device. However, since the raw material is the same and the values comply with the requirements of the relevant standards ISO 20795-1. ISO 20795-2 and the FDA Guidance "Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff", there is no increased risk.
All other features are identical to the Predicate Device / Reference Device.
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Conclusion
Most product specifications and characteristics of the unmodified device are identical to the modified device / reference device. Product specification and characteristics (e.g. application time) have been tested and are shown in the risk analysis. All tests were passed.
This is why Dental Direkt GmbH believes that the modified product DD medical polymers (PMMA) is substantially equivalent to the legally marketed and unmodified device / reference device.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.