(1 days)
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No
The summary describes a dental restorative material and its physical properties, not a software or system that would typically incorporate AI/ML. The device is a material block milled by a CAD/CAM system, and the summary focuses on material properties and performance testing against standards.
No.
The device is a restorative material used for fabricating dental restorations and does not directly provide therapeutic treatment.
No
Explanation: This document describes a material used for dental restorations (inlays, crowns), which is a treatment rather than a diagnostic tool. The device description explicitly states it is a "solid block of material" that is "milled... into restorative form."
No
The device description clearly states it is a "solid block of material" and a "non-sterile material" that is "milled in a dental CAD/CAM machine." This indicates a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of dental restorations (inlays, onlays, veneers, crowns, bridges) using a CAD/CAM system. This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The device is a solid block of material that is milled into a restorative form. It is a material used to create a medical device, not a test or assay performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body. This device is a material used to create a device that will be used in vivo (inside the body).
N/A
Intended Use / Indications for 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.
Product codes
EBF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals and manufacturers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Flexural Strength: 175 MPa
Modulus of Elasticity: 9.9 GPa
Compressive Strength: 490 MPa
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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: +49 (0) 6421.168993.0, creamed.fda@gmail.com
Prepared By: Rich McComas, US Agent, +1 (480) 755.1155
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.
Image /page/3/Picture/13 description: The image shows the word "creamed" in blue font with a yellow swoosh underneath. The word is written in lowercase letters and has a slight shadow effect. The swoosh starts under the "c" and curves up and over the word, ending near the "d".
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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
Comparison | Predicate Device | Subject Device | Similarities /
Differences |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Device Name | Shofu Block HC | AMBARINO®
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
Use | For fabrication of inlays
/ onlays, laminate
veneers, anterior and
posterior full crown
restorations, and
implant crowns and
bridges by dental labs
and manufacturers
using a dental
CAD/CAM system. | 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. | Same |
| Physical State | Cured blocks and discs
in a variety of shapes
and shades | Cured blocks and discs
in a variety of shapes
and shades | Same |
| Structure | Polymer resin /
ceramic hybrid
composite | Polymer resin /
ceramic hybrid
composite | Same |
| Methacrylate | 39% UDMA, TEGDMA | 29% UDMA, BDDMA | Similar. The subject |
| -based Resin Matrix | | | and predicate devices
contain UDMA in their
resin matrix. |
| Filler Content | 61% inorganic
silica-based glass and
silica | 70% inorganic
silica-based glass and
barium glass | Similar |
| Sizes | 14, 98 | 14, 40, 98, 100 | The subject device
size ranges fall within
those of the predicate
devices. |
| Flexural
Strength | 191 MPa | 175 MPa | Similar |
| Modulus of Elasticity | 9.6 GPa | 9.9 GPa | Similar |
| Compressive
Strength | 472 MPa | 490 MPa | Similar |
| Packaging | One disc per box, or
for mandrel mounted
blocks, five to a box | One disc per box, or
for mandrel mounted
blocks, six small or two
large to a box | Same, based on
physical state. |
| Usage | Single Patient,
multiple use | Single Patient,
multiple use | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Conforms with
ISO 10993-1 | Conforms with
ISO 10993-1 | Same |
| Performance | Conforms with
ISO 4049 | Conforms with
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.