AMBARINO High-Class

K222723 · Creamed GmbH & Co. Produktions- Und Handels KG · EBF · Sep 9, 2022 · Dental

Device Facts

• Record ID: K222723
• Device Name: AMBARINO High-Class
• Applicant: Creamed GmbH & Co. Produktions- Und Handels KG
• Product Code: EBF · Dental
• Decision Date: Sep 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

AMBARINO® High-Class is indicated for fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

Device Story

AMBARINO High-Class is a dual-network hybrid restorative material consisting of interpenetrating networks of glass ceramic and polymer resin. Supplied as non-sterile blocks or discs, the material is intended for use by dental professionals or manufacturers. The device is processed via dental CAD/CAM milling machines to create custom dental restorations, including inlays, onlays, veneers, crowns, and implant-supported bridges. The hybrid structure combines the physical properties of ceramic and resin, aiming to reduce brittleness compared to pure ceramics while improving abrasion resistance compared to pure resins. The final milled restoration is polished and placed by a clinician. The device benefits patients by providing durable, tooth-colored restorative options for various dental defects.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included flexural strength, flexural modulus, and compressive strength per ISO 4049, and biocompatibility evaluation per ISO 10993-1 and ISO 7405. Results demonstrated the device meets or exceeds minimum standards and is substantially equivalent to the predicate device.

Technological Characteristics

Dual-network hybrid composite of glass ceramic and polymer resin. Resin matrix contains UDMA and BDDMA; filler content is 70% inorganic silica-based and barium glass. Form factor: blocks and discs. Processing: CAD/CAM milling. Non-sterile. Conforms to ISO 4049 (dentistry polymer-based restorative materials) and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for fabrication of inlays, onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Shofu Block HC (K130841)

Submission Summary (Full Text)

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September 9, 2022

Creamed GmbH & Co. Produktions- und Handels KG % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K222723

Trade/Device Name: AMBARINO High-Class Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: September 2, 2022 Received: September 8, 2022

Dear Dave Yungvirt:

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

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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, 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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K222723

Device Name AMBARINO® High-Class

Indications for Use (Describe)

AMBARINO® High-Class is indicated for fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

| 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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# 510(k) Summary

# 510(k) Number: _ K222723

Submitter: Creamed GmbH & Co. Produktions- und Handels KG Tom-Mutters-Str. 4a, 35041 Marburg, Germany

Contact: Robert Lemmer, President, Tel: [phone], [e-mail]

Prepared By: Rich McComas, US Agent, +1 [phone]

Date Prepared: August 5, 2022

### Device Identification

| Trade Name: | AMBARINO® High-Class |
|-----------------------|----------------------------|
| Common Name: | Restorative resin material |
| Classification Name: | Tooth shade resin material |
| Regulation Number: | 872.3690 |
| Product Code: | EBF |
| Class: | Class II |
| Classification Panel: | Dental |

### Legally Marketed Predicate Device:

- · Shofu Block HC (K130841); Manufacturer: SHOFU DENTAL
Device Description: The AMBARINO® High-Class CAD/CAM formed materials consist of interpenetrating networks of glass ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness compared to a pure ceramic and better abrasion than a pure resin (similar to natural enamel). This non-sterile material is milled in a dental CAD/CAM machine into restorative form for single patient use.

Statement of Intended Use: AMBARINO® High-Class is indicated for fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

Substantial Equivalence: Information provided in this application shows that the product is substantially equivalent to the predicate device. Comparisons of the physical properties of the AMBARINO® High-Class to the predicate devices are included in this application.

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The table below compares AMBARINO® High-Class to the predicate device with respect to its physical state, structure, materials, mechanical properties, indications for use, biocompatibility and performance testing, and provides detailed information regarding the basis for the determination of substantial equivalence.

| Elements of<br>Comparison | Predicate Device | Subject Device | Similarities /<br>Differences |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Device Name | Shofu Block HC | AMBARINO®<br>High-Class | - |
| Manufacturer | SHOFU DENTAL | Creamed | - |
| 510(k) # | K130841 | Pending | - |
| Product Code | EBF, EBG | EBF | - |
| Regulation | §872.3690 | §872.3690 | Same |
| Class | II | II | Same |
| Review Panel | Dental | Dental | Same |
| Device Image | Image: Shofu Block HC | Image: AMBARINO High-Class | - |
| Indications for<br>Use | For fabrication of inlays<br>/ onlays, laminate<br>veneers, anterior and<br>posterior full crown<br>restorations, and<br>implant crowns and<br>bridges by dental labs<br>and manufacturers<br>using a dental<br>CAD/CAM system. | For fabrication of inlays<br>/ onlays, laminate<br>veneers, anterior and<br>posterior full crown<br>restorations, and<br>implant crowns and<br>bridges by dental<br>professionals and<br>manufacturers<br>using a dental<br>CAD/CAM system. | Same |
| Physical State | Cured blocks and discs<br>in a variety of shapes<br>and shades | Cured blocks and discs<br>in a variety of shapes<br>and shades | Same |
| Structure | Polymer resin /<br>ceramic hybrid<br>composite | Polymer resin /<br>ceramic hybrid<br>composite | Same |
| Methacrylate | 39% UDMA, TEGDMA | 29% UDMA, BDDMA | Similar. The subject |
| -based Resin Matrix | | | and predicate devices<br>contain UDMA in their<br>resin matrix. |
| Filler Content | 61% inorganic<br>silica-based glass and<br>silica | 70% inorganic<br>silica-based glass and<br>barium glass | Similar |
| Sizes | 14, 98 | 14, 40, 98, 100 | The subject device<br>size ranges fall within<br>those of the predicate<br>devices. |
| Flexural<br>Strength | 191 MPa | 175 MPa | Similar |
| Modulus of Elasticity | 9.6 GPa | 9.9 GPa | Similar |
| Compressive<br>Strength | 472 MPa | 490 MPa | Similar |
| Packaging | One disc per box, or<br>for mandrel mounted<br>blocks, five to a box | One disc per box, or<br>for mandrel mounted<br>blocks, six small or two<br>large to a box | Same, based on<br>physical state. |
| Usage | Single Patient,<br>multiple use | Single Patient,<br>multiple use | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Conforms with<br>ISO 10993-1 | Conforms with<br>ISO 10993-1 | Same |
| Performance | Conforms with<br>ISO 4049 | Conforms with<br>ISO 4049 | Same |

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Non-Clinical Performance Data: As part of demonstrating substantial equivalence of AMBARINO® High-Class to the predicate device, Creamed submitted finished devices for extensive testing in accordance with the applicable parts of the following voluntary standards, as well as to the company's own internal test protocols:

- · ISO 4049, Dentistry Polymer-based RestorativeMaterials
- ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry 0
- 0 ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process

Testing evaluated flexural strength, flexural modulus, compressive strength, and biocompatibility of the subject device, as well as other related physical properties. The subject device exceeded all minimum test standards, and all documented test results were substantially equivalent to the predicate device.

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Design Characteristics: The geometry of the AMBARINO® High-Class material is shaped into solid block or disc forms as defined by the CAD/CAM manufacturer. The material will be inserted into the CAM machine and milled into its final form, then polished and ready for placement thereafter. This design is substantially equivalent to the predicate device.

Biocompatibility: The functionality of AMBARINO® High-Class as well as their conformance to design input was determined by non-clinical laboratory testing. AMBARINO® High-Class has been tested and meets the biocompatibility requirement.

Conclusion: AMBARINO® High-Class has the same or similar intended use, indications for use, physical attributes, and are fabricated into permanent tooth restorations using the same CAD/CAM manufacturing methods as Shofu Block HC. Additional sizes are available for the submitted device, but within the same range of sizes. The submitted device utilizes a slightly higher percentage of resin and therefore is a little less brittle and has a slightly lower flexural strength, but within the range of substantial equivalence. All performance data of the two devices are similar, and both exceed the minimum requirements. Any minor differences in the materials used to make the subject device when compared to the predicate device have been successfully evaluated by the manufacturer through extensive performance and biocompatibility testing on their device, such that the information submitted to the FDA demonstrates that the subject device is as safe and effective as the predicate device and does not raise any new questions of safety and effectiveness.

AMBARINO® High-Class, as designed and manufactured by Creamed, have been determined to be substantially equivalent to Shofu Block HC.