LogoFDA 510(k) Search
K Number
K211916
Device Name
IPS e.max One
Manufacturer
Ivoclar Vivadent AG
Date Cleared
2021-08-20

(60 days)

Product Code
EIH
Regulation Number
872.6660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Missing tooth structure in anterior and posterior teeth Types of restorations: - Veneers - Inlays - Onlays (e.g. occlusal veneers, partial crowns) - Crowns
Device Description
IPS e.max® One is a glass-ceramic block for the fabrication of fixed, full-contour single-tooth restorations in anterior and posterior teeth. IPS e.max One can be processed in milling machines and polished afterwards. A crystallization process is not necessary. The dentist starts with shade selection, preparation of the tooth based on guidelines for all-ceramic restorations, follow the recommended griding instruments and minimum layer thickness during finalizing and finishing, and finish with dental polishing. Types of restorations: -Veneers -Inlays -Onlays (e.g. occlusal veneers, partial crowns) -Crowns
More Information

K051705

Not Found

No
The device description and performance studies focus on the material properties and fabrication process of a glass-ceramic block for dental restorations. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making.

No
This device is a material (glass-ceramic block) used to fabricate dental restorations, not a device that directly treats a medical condition.

No.
The device is a glass-ceramic block used for fabricating dental restorations (veneers, inlays, onlays, crowns), not for diagnosing medical conditions.

No

The device description clearly states it is a "glass-ceramic block" and describes a physical manufacturing process involving milling and polishing, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The description clearly states that IPS e.max® One is a glass-ceramic block used for fabricating dental restorations (veneers, inlays, onlays, crowns). This is a material used in the body to replace missing tooth structure, not a test performed on a sample from the body.
  • Intended Use: The intended use is to replace missing tooth structure, not to diagnose a condition.
  • Device Description: The description focuses on the material properties and how it is processed and used by a dentist.
  • Performance Studies: The performance studies described are bench testing of physical properties and biocompatibility, which are relevant for a dental restorative material, not for an IVD.

Therefore, IPS e.max® One is a dental restorative material, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

-Missing tooth structure in anterior and posterior teeth

Types of restorations:

  • Veneers
  • Inlays
  • Onlays (e.g. occlusal veneers, partial crowns)
  • Crowns

Product codes (comma separated list FDA assigned to the subject device)

EIH

Device Description

IPS e.max® One is a glass-ceramic block for the fabrication of fixed, full-contour single-tooth restorations in anterior and posterior teeth. IPS e.max One can be processed in milling machines and polished afterwards. A crystallization process is not necessary. The dentist starts with shade selection, preparation of the tooth based on guidelines for all-ceramic restorations, follow the recommended griding instruments and minimum layer thickness during finalizing and finishing, and finish with dental polishing.

Types of restorations: -Veneers -Inlays -Onlays (e.g. occlusal veneers, partial crowns) -Crowns

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior and posterior teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dentist / Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: flexural strength, linear thermal expansion (CTE), chemical solubility, glass transition temperature, and radioactivity according to EN ISO 6872:2015- Dentistry - Ceramic materials (ISO 6872:2015).

The subject device was also evaluated for Biocompatibility according to ISO 10993-1:2009, ISO 7405:2018 and ISO 14971:2019. The biological evaluation was performed based on toxicological data on relevant component materials / compounds, information on prior use of relevant component materials / compounds, data from biological tests, data on the history of clinical use or human exposure.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

IPS e.max CAD (K051705)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.

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August 20, 2021

Ivoclar Vivadent AG % Anderjeet Gulati Sr. Manager QA & Regulatory Affairs Ivoclar Vivadent Inc 175 Pineview Drive Amherst. New York 14228

Re: K211916

Trade/Device Name: IPS e.max One Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: June 9, 2021 Received: June 21, 2021

Dear Anderjeet Gulati:

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) K210115

Device Name IPS e.max® One

Indications for Use (Describe) -Missing tooth structure in anterior and posterior teeth

Types of restorations:

  • Veneers

  • Inlays

  • Onlays (e.g. occlusal veneers, partial crowns)

  • Crowns

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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Image /page/3/Picture/0 description: The image shows the text "510(K) SUMMARY-K211916" in bold black font, followed by the Ivoclar Vivadent logo in blue and green. The logo is a stylized representation of the company name. The number 1 is on the right side of the logo.

| Contact: | Anderjeet Gulati, Sr. Manager QA & Regulatory Affairs
Ivoclar Vivadent, Inc.
175 Pineview Drive
Amherst, New York 14228
716-264-2046
anderjeet.gulati@ivoclarvivadent.com |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | Ivoclar Vivadent, AG
Bendererstrasse 2, Schaan, FL-9494, Liechtenstein
+423-235-3535 |
| Date Prepared: | August 19, 2021 |
| Proprietary Name: | IPS e.max® One |
| Classification Name: | Powder, Porcelain (872.6660)
(Classification Code EIH) |
| Predicate Device: | IPS e.max CAD (K051705) by Ivoclar Vivadent, AG |

Device Description: IPS e.max® One is a glass-ceramic block for the fabrication of fixed, full-contour single-tooth restorations in anterior and posterior teeth. IPS e.max One can be processed in milling machines and polished afterwards. A crystallization process is not necessary. The dentist starts with shade selection, preparation of the tooth based on guidelines for all-ceramic restorations, follow the recommended griding instruments and minimum layer thickness during finalizing and finishing, and finish with dental polishing.

Types of restorations: -Veneers -Inlays -Onlays (e.g. occlusal veneers, partial crowns) -Crowns

Indications for Use:

-Missing tooth structure in anterior and posterior teeth

Types of restorations:

  • i Veneers
  • Inlays
  • Onlays (e.q. occlusal veneers, partial crowns) -
  • -Crowns

Comparison to Predicate: The primary predicate device to which IPS e.max One has been compared is Ivoclar Vivadent, AG IPS e.max CAD (K051705).

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Image /page/4/Figure/1 description: The image shows the Ivoclar Vivadent logo. The logo is in blue and green, with the words "Ivoclar" and "Vivadent" stacked on top of each other. There is a curved line of green and blue dots above the words. The number 2 is in the upper right corner of the image.

| Device | Predicate Device:
Ivoclar Vivadent AG: IPS e.max CAD
(K051705) | Proposed Device:
Ivoclar Vivadent AG: IPS e.max One
(K211916) | Deviation | | |
|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----|---|
| | | | Yes | No | |
| Indications for Use | Indications for Use:
IPS e.max CAD is a CAD/CAM
machinable glass ceramic based on
lithium disilicate for the preparation of
full ceramic crowns, inlays, onlays,
and full ceramic 3-unit anterior
bridges.
IPS e.max ZirCAD consists of
machinable zirconia blocks for the
preparation of full ceramic crowns,
onlays and 3- and 4-unit bridges and
inlay bridges (anterior and molar.) | Indications for Use:
-Missing tooth structure in anterior and
posterior teeth
Types of restorations:
-Veneers
-Inlays
-Onlays (e.g. occlusal veneers,
partial crowns)
-Crowns | ☑ | | |
| Precaution
Measures/
Contraindications/ Processing
restrictions/
Side effects | Contraindications:
-Inlay-retained, cantilever, Maryland
bridges
-Pontic width anterior region > 11mm
-Pontic width premolar region >9 mm
-Temporary incorporation of IPS
e.max CAD restorations
-Fully veneered molar crowns
-Very deep subgingival preparations
-Patients with severely reduced
residual dentition
-Bruxism
-Any other use not listed in the
indications | Contraindications:

  • Patients with substantially reduced
    residual dentition
    Limitations of use
  • Bridge reconstructions
  • Anterior and posterior crowns with
    full (circular) veneer
    – Untreated bruxism (the use of an
    occlusal splint is
    indicated after incorporation)
  • Temporary insertion
  • Very deep sub-gingival preparations | | ☑ | |
    | Summary of
    Indications,
    Precaution
    Measures/
    Contraindications/ Processing
    restrictions/
    Side effects | The new device can be used for veneers, inlays, onlays and crowns (as explained under
    "working principle") like the predicate. In addition the predicate IPS e.max CAD from K051705
    can be used for bridges as well - this indication is lacking for the new device. The
    contraindications for IPS e.max One and the predicate device IPS e.max CAD are basically
    the same, even though the wording slightly differs. The devices can be considered as
    substantially equivalent. | | | | |
    | Working
    Principle | IPS e.max CAD are lithium disilicate
    glass-ceramic blocks for the
    CAD/CAM technology. The blocks are
    processed in CAD/CAM units in their
    crystalline intermediate stage. After
    the IPS e.max CAD blocks are milled,
    the restoration is crystallized in a
    furnace. | IPS e.max One is a glass-ceramic
    block for the fabrication of fixed, full-
    contour single-tooth restorations in
    anterior and posterior teeth
    Types of restoration:
    -Veneers
    -Inlays
    -Onlays (e.g. occlusal veneers, partial
    crowns)
    -Crowns
    IPS e.max One are processed in
    milling machines and polished
    afterwards. A crystallization process is
    not necessary. | ☑ | | |
    | Summary of Working Principle | Both devices are glass-ceramic blocks for the CAD/CAM technology. The main difference is that the new blocks (IPS e.max One) don't need to be crystallized after the milling process. This is an advantage for the customer because the process is less time consuming without the crystallization step. Therefore, the working principle is basically the same for both devices and they are substantially equivalent. | | | | |
    | Delivery forms/dosage | Ceramic blocks in different shades, translucencies and sizes:
  • HT I12, C14, BL1, BL2, BL3, BL4, A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, D2, D3, D4
  • LT I12, C14, C16, B32 BL1, BL2, BL3, BL4, A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, D2, D3, D4
  • MO C14 Shades 0, 1, 2, 3, 4,
  • MT C14 Shades BL2, BL3, BL4, A1, A2, A3 B1
  • Impulse C14 Shades Opal 1, Opal 2 | Ceramic blocks in different shades, translucencies and sizes:
  • Multi C14, A1, A2, A3, A3.5, B1, B2, C2, D2, BL1, BL3
  • HT C14, A1, A2, A3, A3.5, B1, B2, C2, D2, BL1, BL3 | | ☑ | ☐ |
    | Summary of Delivery forms/dosage | The new device is available in less shades and translucencies compared to the predicate device. The new device is available with a color gradient ("Multi") which is a new feature compared to the predicate. | | | | |
    | Storage Conditions | No shelf life | No shelf life | | ☐ | ☑ |
    | Summary of Storage Conditions | No difference. | | | | |
    | Principles of Operation | Step-by-step:
  • Shade selection
  • Preparation
  • Finishing
  • Completion with Crystallization | | Step-by-step:
  • Shade selection
  • Preparation
  • Finishing
  • Completion | ☑ | ☐ |
    | Summary Principles of operation | Basically, the principle of operation is substantially equivalent between the predicate and the new device. The slight difference in the step-by-step application is explained through the fact, that there is no crystallization step needed for the new device IPS e.max One which results in time saving for the customer. | | | | |
    | Summary of Chemical Composition | Both products are dental glass-ceramic blocks used for the CAD/CAM technology in order to create dental restorations. The new formulation for IPS e.max One has been thoroughly assessed for biocompatibility and the biocompatibility is substantially equivalent to the predicate device. See biocompatibility assessment for IPS e.max One is part of the submission. | | | | |
    | Finished Device Specification | ISO 6872:1995 – Dental Ceramic | | ISO 6872:2015 - Dentistry – Ceramic materials | ☑ | ☐ |
    | Summary of Finished Device Specification | The predicate device was compliant with ISO 6872 from 1995. IPS e.max One is following the same standard from 2015. IPS e.max Ones is a class 3, Type II according to ISO 6872:2015. | | | | |
    | Sterilization | Not applicable. No sterilization recommendation. | | Not applicable. No sterilization recommendation. | ☐ | ☑ |
    | Single use | Consumable material | | Consumable material | | ☑ |
    | Summary of Performance Specification | The predicate device IPS e.max CAD followed the requirements from ISO standard 6872: Dental Ceramic from 1995. The new device IPS e.max One follows the requirements of the same standard, however form year 2015. | | | | |

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Image /page/5/Picture/1 description: The image shows the Ivoclar Vivadent logo in blue with a green and blue arc of dots above it. The word "Ivoclar" is on top of the word "Vivadent". The registered trademark symbol is to the right of the word "Vivadent". The number 3 is in the lower right corner of the image.

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Image /page/6/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green, with the words "Ivoclar Vivadent" in a stylized font. There are green and blue dots above and to the right of the words. The number 4 is in the lower right corner of the image.

Therefore, the performance criteria can be considered as substantially equivalent.

Substantial Equivalence to the predicate:

IPS e.max CAD and IPS e.max One are both millable blocks used for dental restorations. The products are both dental ceramic materials even though the chemical composition differs. The new device covers the indications offered by the predicate device but lacks the indications of bridges. Both blocks are milled in CAD/CAM milling machines. The predicate device needs to undergo a crystallization process after milling which is not needed for IPS e.max One.

Therefore, IPS e.max One is substantially equivalent to the predicate device IPS e.max CAD.

Differences:

The new device can be used for veneers, inlays, onlays and crowns (as explained under "working principle") like the predicate. In addition, the predicate IPS e.max CAD from K051705 can be used for bridges as well - this indication is lacking for the new device.

The working principle of the predicate and the new device is basically the same. Both devices are blocks milled in CAD/CAM milling machines, but the crystallization process is not needed for the new device IPS e.max One compared to the predicate.

The chemical composition is different. However, both devices are dental ceramic materials.

Non-clinical performance testing:

Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: flexural strength, linear thermal expansion (CTE), chemical solubility, glass transition temperature, and radioactivity according to EN ISO 6872:2015- Dentistry - Ceramic materials (ISO 6872:2015).

Biocompatibility:

The subject device was also evaluated for Biocompatibility according to ISO 10993-1:2009, ISO 7405:2018 and ISO 14971:2019. The biological evaluation was performed based on toxicological data on relevant component materials / compounds, information on prior use of relevant component materials / compounds, data from biological tests, data on the history of clinical use or human exposure. On the basis of the information included in the biological evaluation report it can be concluded that the extract of the product is not cytotoxic, no sensitizing potential is reported for lithium disilicate glass-ceramic blocks (LS2) as New Millable GC does not induce oral mucosal irritation. New Millable GC holds no potential for material-mediated pyrogenicity, New Millable presents no risks for acute, sub-acute, sub-chronic toxicity. Extracts of the product are not genotoxic, the risk of carcinogenicity induced by the product is negligible, the products have no direct contact to pulp or dentin. It can be concluded that the product does not represent a toxicological risk for the patient and the user.

On the basis of the toxicological evaluation of the product and the longstanding worldwide clinical use of similar materials it can be concluded that the benefits provided by the final product will

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Image /page/7/Picture/1 description: The image shows the Ivoclar Vivadent logo. The logo is blue and green, and it features the company name in a stylized font. Above the company name is a series of green and blue dots and squares. To the right of the logo is the number 5.

exceed any potential risks produced by device materials providing that instructions for use have been followed.

Conclusion:

IPS e.max CAD and IPS e.max One are both millable blocks used for dental restorations. The products are both dental ceramic materials even though the chemical composition differs. The new device covers the indications offered by the predicate device but lacks the indications of bridges. Both blocks are milled in CAD/CAM milling machines. The predicate device needs to undergo a crystallization process after milling which is not needed for IPS e.max One.

Therefore, IPS e.max One is substantially equivalent to the predicate device IPS e.max CAD.