Who is the manufacturer of DD medical polymers (PMMA)?

Dental Direkt GmbH filed the 510(k) submission for DD medical polymers (PMMA) (K230410).

What is the FDA product code for DD medical polymers (PMMA)?

EBI. It is classified under 21 CFR 872.3760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for DD medical polymers (PMMA)?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like DD medical polymers (PMMA)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DD medical polymers (PMMA)

K230410 · Dental Direkt GmbH · EBI · Jun 23, 2023 · Dental

Device Facts

Record ID	K230410
Device Name	DD medical polymers (PMMA)
Applicant	Dental Direkt GmbH
Product Code	EBI · Dental
Decision Date	Jun 23, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 872.3760
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 regulators for long-term application in the oral cavity up to 12 months.

Device Story

DD medical polymers (PMMA) are industrially polymerized, pre-colored or clear dental milling blanks. Used by dental technicians in dental CAD/CAM systems to mill denture bases (gingiva-colored) or bite splints (clear). Input is digital design data; output is physical dental appliance. Device provides long-term restorative or therapeutic function in the oral cavity. Benefits include patient-specific fit and durability for removable dentures or splint therapy. No clinical data; device relies on established material history and bench testing.

Clinical Evidence

Bench testing only. No clinical data conducted. Biocompatibility validated per EN ISO 10993-1 and EN ISO 10993-5. Physical properties validated against ISO 20795-1 and ISO 20795-2. Accelerated aging tests simulated 10-year use with no biocompatibility abnormalities.

Technological Characteristics

Material: Polymethyl methacrylate (PMMA) (>99.0 wt%) with coloring pigments (≤1.0 wt%). Form factor: Milling discs. Standards: ISO 20795-1 (denture base polymers), ISO 20795-2 (orthodontic base polymers), EN ISO 10993-1/5 (biocompatibility). Processing: CAD/CAM milling. Connectivity: None (standalone material).

Indications for Use

Indicated for patients requiring removable denture bases (DD base P HI) or dental splints, therapeutic splints, and bite regulators (DD Bio Splint P HI). DD base P HI is for long-term use up to 10 years; DD Bio Splint P HI is for long-term application up to 12 months.

Regulatory Classification

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.

Predicate Devices

DD medical polymers (K153490)

Reference Devices

IDODENTINE DISC (K150432)

Related Devices

K153490 — DD medical polymers · Dental Direkt GmbH · May 13, 2016
K200676 — ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA · Zirkonzahn Srl · Jul 8, 2020
K180562 — TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT · Zirkonzahn GmbH · Jun 28, 2018
K134015 — M-PM-DISC · Merz Dental GmbH · Apr 11, 2014
K153546 — PINK CAD/CAM disc · Polident D.O.O., Dental Products Industry · Sep 28, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### Indications for Use Submission Number (if known) K230410 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary ## as required by 21 CFR 807.92(c) {4}------------------------------------------------ 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 K153490: 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 {5}------------------------------------------------ | Indications for Use | DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months. 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. | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description | 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. | | Technological Characteristics | The technological characteristics of the modified device are comparable to the legally marketed device. The physical properties are not identical to the Predicate Device but can be considered as sufficient, since the values 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. All devices are made of PMMA, partly with small amounts of coloring pigments. | | Material | PMMA | | Discussion of Tests Performed | Clinical Tests Dental Direkt GmbH did not conduct, nor rely upon, clinical tests to determine substantial equivalence as dental polymers that fall under the FDA product codes MQC and EBI have a long history of safe and effective use in the US. Non Clinical Tests Non-clinical testing was performed in order to validate the product against the company's specified design requirements according to the following standards: EN ISO 10993-1 (biological compatibility) and EN ISO 10993-5 (cytotoxicity) DD medical polymers (PMMA) were tested by an accredited testing laboratory with respect to biocompatibility. Based on the test results DD medical polymers was classified as eminently suitable for use in the dental applications. | {6}------------------------------------------------ - 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) {7}------------------------------------------------ | 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 HI DD Bio Splint P HI | DD temp MED DD 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 to Reference 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 of this 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 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 regulators for long-term application in the oral cavity up to 12 months. | DD medical polymers are indicated for temporary (≤ 12 months) crowns, bridges and bite splints. Applications include both anterior and posterior structures. | Acrylic polymer blank particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM. Indications: - Temporary anterior and posterior crowns - Temporary anterior and posterior bridges with up to two adjacent pontics - Implant supported temporary restorations Maximum recommended usage period: 12 months | DD Bio Splint P HI: Identical to Predicate Device DD base P HI: Identical to Reference Device: - different wording, but identical (both suitable for removable denture bases) - wording of Reference Device is much more general (see discussion) | | Feature | New Device | Primary Predicate Device | Reference Device | Comment | | | | | - Removable structures for dentures (dental bases) - Removable structures for therapeutic restorations (bite splints or occlusal splints) | | | Max. application | 12 months (DD Bio Splint P HI) | 12 months | 12 months | Identical to Predicate Device | | | 10 years (DD base P HI) | | Not restricted | Comparable to Reference Device, see discussion | | Technology | Blank for dental CAD/CAM machining | Blank for dental CAD/CAM machining | Blank for dental CAD/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%] (Polymethyl methacrylate) | > 99.0 [wt%] (Polymethyl methacrylate) | Polymethyl methacrylate | Identical to Predicate Device | | Coloring pigments | ≤ 1.0 [wt%] | ≤ 1.0 [wt%] | Not specified | Identical to Predicate Device | | Feature | New Device | Primary Predicate Device | Reference Device | Comment | | | Physical characteristics [Units] | | | | | Flexural strength | ≥ 64 MPa | ≥ 75 MPa | 90 MPa | Comparable (see discussion) | | Flexural modulus | ≤ 2030 MPa | 2800 (± 200) MPa | Not stated in 510(k) submission | Comparable (see discussion) | | Water absorbtion | < 24 µg/mm³ | ≤ 23 µg/mm³ | < 23 µg/mm³ | Comparable (see discussion) | | Solubility | < 0.3 µg/mm³ | 0.2 µg/mm³ | < 0.0 µg/mm³ | Comparable (see discussion) | | Residual monomer content | < 0.7 % | 0.4 % | < 1.4 % | Comparable (see discussion) | | Stress intensity factor | ≥ 2.4 MPa*m1/2 (DD base P HI) | Not stated in 510(k) submission | Not stated in 510(k) submission | See discussion | | Fracture work | > 2200 J/m² (DD base P HI) | Not stated in 510(k) submission | Not stated in 510(k) submission | See discussion | | Physical tests according to: | ISO 10477 (only relevant excerpts), ISO 20795-1, ISO 20795-2 | ISO 10477, ISO 20795-1 | ISO 10477, ISO 20795-1 | Comparable (see discussion) | | Biocompatibilty tests according to: | EN ISO 10993-1, -5 | EN ISO 10993-1, -5 | EN ISO 10993-1, -5 | Identical | {8}------------------------------------------------ {9}------------------------------------------------ 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 {10}------------------------------------------------ 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. {11}------------------------------------------------ ### 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.