Pressing on metal frameworks and superstructures for the fabrication of full-contour crowns and bridges (staining technique)
Pressing on metal frameworks and superstructures for the fabrication of partially anatomic crowns and bridges (cut-back technique)
Pressing of ceramic margins (metal-ceramic)
Pressing of gingiva components (metal-ceramic)
Processing on the most popular dental alloys in the CTE range of 13.8 14.5 10-6/K
(25 500°C) (Cu< 1%, Ag < 10%)
-- Veneering with the layering materials of IPS Style in the conventional layering technique
Characterization with IPS Ivocolor Shade and Essence stains
Glazing with IPS Ivocolor Glaze

Intended Use: IPS Style Ceram and IPS Style Ceram Onc

Conventional multi-layer veneering ceramic for the most popular dental alloys (including electroplating) in the CTE range of 13.8 - 15.2 x 10-6/K (25 - 500°C)

(IPS Style Ceram)

One-layer veneering ceramic for the most popular dental alloys (including electroplating)

in the CTE range of 13.8 - 15.2 x 10-6/K (25 - 500°C) (IPS Style Ceram One)

Veneers on refractory die material (only IPS Style Ceram)
Characterization and veneering of IPS Style Press restorations
Characterization with IPS Ivocolor Shade and Essence stains
Glazing with IPS Ivocolor Glaze

Device Description

IPS Style comprises both materials for the conventional veneering technique and the press technique.

. IPS Style Ceram: is available as Opaquer 870 in 42 Shades, Opaquer 960 in 42 shades, Margin Powder in 11 Shades, Dentin porcelain in 32 Shades, deep Dentin porcelain in 16 Shades, Incisal Porcelain in 10 Shades, Transparent Porcelain 7 Shades, Mamelon in 3 shades, Occlusal Dentin 2 Shades, Incisal Edge 1 Shade, Opal Effect in 6 Shades, Special Incisal 2 Shades, Inter Incisal 1 Shades, Cerv. Transparent 4 Shades, Add on Ceramic 4 Shades, Bleach Ceramic in 14 Shades, Gingiva Porcelain in 11 Shades and 4 Liquids.
IPS Style Ceram One: is available in 16 Shades and Shades Guides .
. IPS Style Press: Press Ingots LT is available in 8 Shades, Press Ingot HT in 8 Shades and Press Ingot Gingiva in 1 Shade.
. IPS Style Liquids including Build-up and Opaquer which burn out after firing.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding dental ceramic materials (IPS Style Ceram, IPS Style Ceram One, and IPS Style Press). This type of document focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for the new device as would be found in a clinical trial report or a performance study for a novel device.

Therefore, the requested information cannot be fully extracted from the provided text for the following reasons:

Nature of the Document: A 510(k) summary primarily demonstrates that a new device is "substantially equivalent" to a predicate device already on the market. This often involves comparing chemical compositions, physical properties, indications for use, and working principles, as well as showing compliance with relevant international standards. It does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or an MRMC study comparing AI performance against human readers.
Device Type: The devices described are dental ceramic materials (porcelain powders and press ingots) used for fabricating dental restorations. These are materials, not diagnostic AI devices or devices that produce a clinical "read" that would typically be evaluated with metrics like sensitivity, specificity, or reader performance improvement.
Focus on Equivalence: The document explicitly states, "The comparison shows that IPS Style Ceram and IPS Style Ceram One are substantially equivalent to the predicate device" and "IPS Style Press is substantially equivalent to the predicate device." The "acceptance criteria" here are essentially meeting the standards of the predicate and relevant ISO standards for physical and biocompatibility properties.

However, I can extract information related to the physical properties and biocompatibility assessments, which serve as foundational "acceptance criteria" for this type of material device within the context of a 510(k) submission.

Analysis of the Provided Text for "Acceptance Criteria"

Based on the information provided, the "acceptance criteria" for these dental ceramic materials are primarily focused on:

Biocompatibility: The device must not cause adverse biological reactions.
Physical Properties: The device must meet the requirements of relevant ISO standards for dental ceramics, especially regarding flexural strength and metal-ceramic bond strength.
Chemical Composition: The key ingredients should be silica-based dental glass ceramic with similar elements to the predicate.
Indications for Use & Working Principle: The device should have similar intended uses and working principles to its predicate devices.

Extracted Information:

1. Table of "Acceptance Criteria" and Reported Device "Performance" (Based on Material Characteristics and Standards)

Acceptance Criteria Category	Specific Criteria/Standard	Predicate Devices (K121359 & K071848) Performance	IPS Style (New Device) Performance
Biocompatibility	ISO 10993-1:2009 standards	"not expected to cause any adverse mucosal reactions."	Assessed for cytotoxicity (no cytotoxic potential), genotoxicity (non-mutagenic), sensitization, acute & subchronic systemic toxicity, implantation, and radioactivity. "fully assessed and is equivalent to IPS 99."
Physical Properties	ISO 6872	"meets the requirements."	"meets the requirements."
Physical Properties	ISO 9693 (Debonding/crack initiation strength)	"meets the requirements."	"meets the requirements."
Physical Properties	Flexural Strength	Met requirements of product-specific standard.	"new value fulfils the requirements of the product-specific standard. The test results for flexural strength are significantly above the specification and similar to those of the predicate device IPS InLine PoM."
Physical Properties	Metal-Ceramic Bond	Met requirements of product-specific standard.	"fulfill the requirements for metal-ceramic bond given in the product-specific standard."
Chemical Composition	Key ingredients	Silica-based dental glass ceramic.	"Silica-based dental glass ceramic including the chemical elements: aluminum, lithium, zirconium, yttrium, potassium, phosphorous, magnesium, cerium, boron, calcium, sodium, titanium., strontium, fluoride, zinc, lanthanum."
CTE Range	IPS Style Ceram	13.8-15.0 x 10^-6/K (25-500°C)	13.8 – 15.2 x 10^-6/K (25 – 500°C)
CTE Range	IPS Style Press	13.8 - 14.5 x 10^-6/K (25-500°C)	13.8 – 14.5 x 10^-6/K (25 – 500°C)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not explicitly stated for physical property tests. The document mentions that "The product has been tested to ISO 6872" and "ISO 9693" and "The test results for flexural strength are significantly above the specification." However, the exact sample sizes (number of specimens tested) for these mechanical tests are not provided in this summary.
Data Provenance: Not specified, but generally, such tests are conducted in-house by the manufacturer (Ivoclar Vivadent Ag, Liechtenstein) or by accredited testing laboratories on behalf of the manufacturer. The date prepared is May 16, 2016.

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)

Not applicable/Not stated. This type of information is relevant for studies involving human interpretation or clinical outcomes, typically for diagnostic or treatment devices. For material science properties and biocompatibility, "ground truth" is established through standardized laboratory tests and analytical methods, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

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

No. An MRMC study is not relevant for this type of material device. This is typically used for AI-powered diagnostic imaging or medical decision support systems involving human readers/interpreters.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This device is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For biocompatibility: Laboratory test results following ISO 10993-1, including cytotoxicity and genotoxicity assessments.
For physical properties: Measurements obtained through standardized laboratory testing methods conforming to ISO 6872 and ISO 9693. This generates objective, quantitative data.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI algorithm that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of three human profiles facing right, layered on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2016

Ivoclar Vivadent Ag % Ms. Donna Hartnett Director Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst. New York 14228

Re: K152103

Trade/Device Name: Ips Style Ceram, Ips Style Ceram One, Ips Style Press Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 8, 2016 Received: April 11, 2016

Dear Ms. Hartnett:

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. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

IPS Style Ceram, IPS Style Ceram One, and IPS Style Press

Indications for Use (Describe)

Intended Use: IPS Style Press

Pressing on metal frameworks and superstructures for the fabrication of full-contour crowns and bridges (staining technique)
Pressing on metal frameworks and superstructures for the fabrication of partially anatomic crowns and bridges (cut-back technique)
Pressing of ceramic margins (metal-ceramic)
Pressing of gingiva components (metal-ceramic)
Processing on the most popular dental alloys in the CTE range of 13.8 14.5 10-6/K
(25 500°C) (Cu< 1%, Ag < 10%)
-- Veneering with the layering materials of IPS Style in the conventional layering technique
Characterization with IPS Ivocolor Shade and Essence stains
Glazing with IPS Ivocolor Glaze

Intended Use: IPS Style Ceram and IPS Style Ceram Onc

Conventional multi-layer veneering ceramic for the most popular dental alloys (including electroplating) in the CTE range of 13.8 - 15.2 x 10-6/K (25 - 500°C)

(IPS Style Ceram)

One-layer veneering ceramic for the most popular dental alloys (including electroplating)

in the CTE range of 13.8 - 15.2 x 10-6/K (25 - 500°C) (IPS Style Ceram One)

Veneers on refractory die material (only IPS Style Ceram)
Characterization and veneering of IPS Style Press restorations
Characterization with IPS Ivocolor Shade and Essence stains
Glazing with IPS Ivocolor Glaze

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.

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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Image /page/3/Picture/1 description: The image is a logo for Ivoclar Vivadent. The logo features the company name in a bold, blue sans-serif font. Above the name is an arc of green and blue dots and squares. Below the name is the company's slogan, "passion vision innovation," in a smaller, red sans-serif font.

IPS Style Ceram-IPS Style Ceram One-IPS Style Press

Contact:	Donna Marie Hartnett
Company:	Ivoclar Vivadent, AGBendererstrasse 2, Schaan, FL-9494, Liechtenstein+423-235-3535
Date Prepared:	May 16, 2016
Proprietary Name:	IPS Style CeramIPS Style Ceram OneIPS Style Press
Classification Name:	Powder, Porcelain for clinical useCFR Regulation (872.6660)(Classification Code EIH)
Predicate Device:	IPS 99 One and IPS 99 Ceram (K121359)IPS InLine PoM System (K071848)

Device Description:

IPS Style comprises both materials for the conventional veneering technique and the press technique.

. IPS Style Ceram: is available as Opaquer 870 in 42 Shades, Opaquer 960 in 42 shades, Margin Powder in 11 Shades, Dentin porcelain in 32 Shades, deep Dentin porcelain in 16 Shades, Incisal Porcelain in 10 Shades, Transparent Porcelain 7 Shades, Mamelon in 3 shades, Occlusal Dentin 2 Shades, Incisal Edge 1 Shade, Opal Effect in 6 Shades, Special Incisal 2 Shades, Inter Incisal 1 Shades, Cerv. Transparent 4 Shades, Add on Ceramic 4 Shades, Bleach Ceramic in 14 Shades, Gingiva Porcelain in 11 Shades and 4 Liquids.
IPS Style Ceram One: is available in 16 Shades and Shades Guides .
. IPS Style Press: Press Ingots LT is available in 8 Shades, Press Ingot HT in 8 Shades and Press Ingot Gingiva in 1 Shade.
. IPS Style Liquids including Build-up and Opaquer which burn out after firing.

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Image /page/4/Picture/1 description: The image is the logo for Ivoclar Vivadent. The logo has the company name in a large, bold, sans-serif font, with "Ivoclar" on top and "Vivadent" below it. Above the company name is a series of green and blue dots and squares. Below the company name is the company's slogan, "passion vision innovation", in a smaller, red, sans-serif font.

IPS Style Ceram-IPS Style Ceram One-IPS Style Press

Intended Use: IPS Style Press

– Pressing on metal frameworks and superstructures for the fabrication of full-contour crowns and bridges (staining technique)

– Pressing on metal frameworks and superstructures for the fabrication of partially anatomic crowns and bridges (cut-back technique)

Pressing of ceramic marqins (metal-ceramic)
Pressing of gingiva components (metal-ceramic)
Processing on dental alloys in the CTE range of 13.8 14.5 10-6/K
(25 500°C) (Cu< 1%, Ag ≤ 10%)
Veneering with the layering materials of IPS Style in the conventional layering technique
Characterization with IPS Ivocolor Shade and Essence stains
Glazing with IPS Ivocolor Glaze

IPS Style Ceram and IPS Style Ceram One

Conventional multi-layer veneering ceramic for dental alloys (including electroplating) in the CTE range of 13.8 - 15.2 x 10-6/K (25 - 500°C) (IPS Style Ceram)
One-layer veneering ceramic for dental alloys (including electroplating) in the CTE range of 13.8 - 15.2 x 10-6/K (25 - 500°C) (IPS Style Ceram One)
Veneers on refractory die material (only IPS Style Ceram)
Characterization and veneering of IPS Style Press restorations
Characterization with IPS Ivocolor Shade and Essence stains
Glazing with IPS Ivocolor Glaze

Comparison to Predicate: The predicate devices to which IPS Style Ceram and IPS Style Ceram One has been compared are IPS 99 One and IPS 99 Ceram (K121359) and IPS Style Press has been compared to IPS InLine PoM System (K071848). IPS Style Ceram and IPS Style Ceram One are both ceramic systems for the fabrication of dental restorations on a dental alloy framework. For this application, IPS Style Ceram and IPS Style Ceram One have been compared to its predicate with regard to the chemical compositions, physical properties, operating principals and indications for use. The comparison shows that IPS Style Ceram and IPS Style Ceram One are substantially equivalent to the predicate device.

Biocompatibility: The device was evaluated in connection with ISO 10993-1:2009 Biocompatibility evaluation of medical device – Part 1 and tested for cytotoxicity and genotoxicity and the device possessed no cytotoxic potential and is considered to be nonmutagenic. The device was also evaluated for sensitization, acute and subchronic systemic toxicity, implantation and radioactivity. Based on these results, and a review of cytotoxicity and toxicological data of the predicate device is not expected to cause any adverse mucosal reactions and does not present a toxicological risk for the patient or user.

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passion vision innovation

IPS Style Ceram-IPS Style Ceram One-IPS Style Press

	Predicate devicesK121359 & K071848	IPS Style
Indications	The IPS 99 system contains shades, stains and glaze materials used for the characterization of metal ceramic restorations. In addition: IPS 99 Ceram is a conventional multi-layer veneering ceramic for the fabrication of metal-ceramic restorations using dental alloys in the CTE range of 13.8-15.0 x10-6/K (25-500°C). IPS 99 One is a one-layer veneering ceramic for the fabrication of metal-ceramic restorations using dental alloys in the CTE range of 13.8-15.0 x10-6/K (25-500°C). IPS 99 is intended to be used for inlays, onlays, veneers and anterior/posterior PFM crowns.	IPS Style Ceram and IPS Style Ceram One is a ceramic system for the fabrication of dental restorations on a dental alloy framework. - Conventional multi-layer veneering ceramic for dental alloys (including electroplating) in the CTE range of 13.8 – 15.2 x 10-6/K (25 – 500°C) (IPS Style Ceram) - One-layer veneering ceramic for dental alloys (including electroplating) in the CTE range of 13.8 – 15.2 x 10-6/K (25 – 500°C) (IPS Style Ceram One) – Veneers on refractory die material (only IPS Style Ceram) - Characterization and veneering of IPS Style Press restorations - Characterization with IPS Ivocolor Shade and Essence stains - Glazing with IPS Ivocolor Glaze
	IPS InLine PoM is a leucite ceramic system for pressing fully anatomical restorations on metal crown and bridge frameworks after the application of opaque, mainly in the posterior region. Alloy CTE range: 13.8-14.5 x10 -6 /K (25-500°C). IPS InLine PoM should be used only with dental alloys having Ag<10%.	IPS Style Press; Pressing on metal frameworks and superstructures for the fabrication of full-contour crown and bridges (staining technique). Pressing on metal frameworks and superstructures for the fabrication of partially anatomic crowns and bridges (cut-back technique). Pressing of ceramic margins (metal-ceramic). Pressing of gingiva components (metal-ceramic). Processing on dental alloys in the CTE range of 13.8-14.5 10-6/K (25-500°C) Cu<1%, Ag<10%). Veneering with the layering materials IPS Style in the conventional layering technique. Characterization with IPS Ivocolor Shade and Essence stains. Glazing with IPS Ivocolor Glaze.
Summary Indications	The main difference between IPS Style and the IPS 99 range is that the IPS Style Ceram powders can be layered on IPS Style Press materials. In contrast, layering of IPS InLine Dentin, Incisal, Deep Dentin, Margin, Impulse and Gingiva materials on IPS InLine PoM was not included in the indication. The new materials have been specifically developed to be used together and the processing steps are compatible (e.g. firing temperatures).

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Image /page/6/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "Ivoclar" in green and "Vivadent" in blue. Above the company name is an arc of green and blue dots. Below the company name is the slogan "passion vision innovation" in a smaller font.

IPS Style Ceram-IPS Style Ceram One-IPS Style Press

	Predicate devices	IPS Style
Working principle	IPS 99 is used as a conventional veneeringmaterial on dental alloy frameworks.IPS InLine PoM is used in the press-ontechnique on dental alloy frameworks.The products are available in a variety ofshades and can be characterized usingshades, stains and glaze in the same productfamily.	IPS Style includes materials for conventionalveneering and pressing-on dental alloyframeworks.The products ae available in a variety ofshades.They are characterized using shades, stainsand glaze in the IPS Ivocolor universal system
Summary WorkingPrinciple	IPS Style combines conventional veneering and press-on technology in one product family andone 510k application. The products have been developed together and in particular the IPSStyle Ceram powders can be layered on IPS Style Press.In contrast to the predicates, IPS Style does not include shade, stain and glaze materials. It isintended that the new universal products IPS Ivocolor are used.
Summary Composition	The key ingredients, is silica-based dental glass ceramic including the chemical elements:aluminum, lithium, zirconium, yttrium, potassium, phosphorous, magnesium, cerium, boron,calcium, sodium, titanium., strontium, fluoride, zinc, lanthanum.The device was evaluated in connection with ISO 10993-1:2009 Biocompatibility evaluation ofmedical device – Part 1 and tested for cytotoxicity and genotoxicity and the device possessedno cytotoxic potential and is considered to be non-mutagenic. Based on these results, and areview of cytotoxicity and toxicological data of the predicate devices, the device is not expectedto cause any adverse mucosal reactions.The biocompatibility of the new formulation was fully assessed and is equivalent to IPS 99.There are some minor differences to the liquids compositions but this only affects handling asthe liquids burn out during firing.
Physical Properties	The product has been tested to ISO 6872 andmeets the requirements. The product is alsotested under ISO 9693 for Debonding/crackinitiation strength and meets the requirements.	The product has been tested to ISO 6872 andmeets the requirements. IPS Style Ceram,IPS Style Ceram One and IPS Style Press arethe same Type and Class material as thepredicate. The product is also tested underISO 9693 for Debonding/crack initiationstrength and meets the requirements.
Summary Physicalproperties	The specified flexural strength of IPS Style Press is lower than that of IPS InLine PoM.However the new value fulfils the requirements of the product-specific standard. The testresults for flexural strength are significantly above the specification and similar to those of thepredicate device IPS InLine PoM.In all other aspects the new products lie in the same ranges as the predicates. The variationsare minimal. In addition the new products fulfill the requirements for metal-ceramic bond givenin the product-specific standard.

Conclusion:

The main difference between IPS Style and the IPS 99 range is that the IPS Style Ceram powders can be layered on IPS Style Press materials. In contrast, layering of IPS InLine Dentin, Incisal, Deep Dentin, Margin, Impulse and Gingiva materials on IPS InLine PoM was not included in the indication. It combines conventional veneering and press-on technology in one product family.

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Image /page/7/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is blue and green, with the words "Ivoclar Vivadent" in a large, bold font. Below the company name is the slogan "passion vision innovation" in a smaller font. Above the company name is a series of green and blue dots and squares.

IPS Style Ceram-IPS Style Ceram One-IPS Style Press

Therefore IPS Style Ceram and IPS Style Ceram One and are substantially equivalent to the predicate device, IPS 99 One and IPS 99 Ceram. IPS Style Press is substantially equivalent to the predicate device, IPS InLine PoM System.

Regulation Number and Section

§ 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.