Provisional anterior and posterior crowns with a maximum wear period of up to 12 months
Provisional anterior and posterior bridges with up to two adjacent pontics for a maximum wear period of up to 12 months
Provisional inlay and onlays

Device Description

Telio CAD Multi are PMMA discs used for fabrication of long-term temporaries by means of CAD/CAM technology. The PMMA discs have a Long-term (12-month) wear period and durable shade stability with lifelike layered appearance. The device is available in 8 shades (BL2, A1, A2, A3, A3.5, A4, B1 and B2) and 4 thicknesses 12mm, 16mm, 20mm and 25mm. They are the standard 98.5 mm in diameter to permit use with the Wieland Select Milling equipment or other equipment which accepts 98.5 mm discs. The material exhibits high homogeneity due to industrial manufacturing process and temporaries can be easily reproduced using the CAD/CAM Technology. The device is contraindicated for use in permanent restorations and bridge designs involving more than two adjacent pontics. The device should not be used in patients with para-functional habits, ex. Bruxism or patients known to be allergic to the ingredients.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the TelioCAD Multi device, structured to answer your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily references meeting existing ISO standards rather than defining new, specific acceptance criteria with numerical targets. The "Reported Device Performance" simply states that the device "met all requirements of the standard."

Acceptance Criteria (Standard Reference)	Reported Device Performance (Met/Did Not Meet)
ISO 10477:2004 Dentistry - Polymer based crown and bridge materials (for Surface finish, Flexural Strength, Bond strength, Water Sorption, Solubility, Shade Consistency, Color stability)	Met all requirements
ISO 20795-1:2013 Dentistry - Base Polymers - Part 1: Denture Base Polymers (for Modulus of Elasticity, Residual monomer)	Met these requirements
ISO 179-1:2010 Charpy toughness	Conducted (no pass/fail stated, but implied positive for "additional insight")
ISO 180:2000 Izod impact strength	Conducted (no pass/fail stated, but implied positive for "additional insight")
ISO 868:2003 Vickers Hardness (converted from Shore D)	Conducted (no pass/fail stated, but implied positive for "additional insight")
ISO 10993-1 Biocompatibility	No new elements, no change in biocompatibility
ISO 7504 Biocompatibility	No new elements, no change in biocompatibility

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the tests conducted according to the ISO standards.
The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer as part of their 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this document. The "ground truth" here is defined by objective physical and chemical measurements against established international standards for dental materials, not through expert consensus or clinical judgment on a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is based on objective material testing against ISO standards, not on human interpretation that would require an adjudication method.

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

This information is not applicable. TelioCAD Multi is a dental material (PMMA discs for temporary restorations), not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study and effect size in this context are irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. As stated above, this device is a dental material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established international standards for dental materials (ISO standards 10477:2004, 20795-1:2013, 179-1:2010, 180:2000, 868:2003, 10993-1, 7504). These standards define the acceptable physical, mechanical, and biological properties for the material's intended use.

8. The Sample Size for the Training Set

This information is not applicable. This device is a material, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.

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

April 12, 2016

Ivoclar Vivadent, Inc. Ms. Donna Marie Hartnett, Esq. Director QA/Regulatory Affairs 175 Pineview Drive Amherst, New York 14228

Re: K153753

Trade/Device Name: TelioCAD Multi Regulation Number: 21 CFR 872.3770 Regulatory Class: Class II Product Code: EBG Dated: March 4, 2016 Received: March 8, 2016

Dear Ms. Donna Marie 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Erin I. Keith-S

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) K153753

Device Name TelioCAD Multi

Indications for Use (Describe)

For manufacturing by a CAD/CAM System:

Provisional anterior and posterior crowns with a maximum wear period of up to 12 months
Provisional anterior and posterior bridges with up to two adjacent pontics for a maximum wear period of up to 12 months
Provisional inlay and onlays

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)

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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510(K) SUMMARY

TelioCAD Multi Rev April 11, 2016

Image /page/3/Picture/2 description: The image is a logo for Ivoclar Vivadent. The words "Ivoclar Vivadent" are written in a blue sans-serif font, with the "i" in "Ivoclar" being slightly larger than the other letters. Above the words "Ivoclar Vivadent" is an arc of green and blue circles and squares. Below the words "Ivoclar Vivadent" are the words "passion vision innovation" in a smaller, red sans-serif font.

Contact:	Donna Marie Hartnett
Company:	Ivoclar Vivadent, Inc.175 Pineview Drive, Amherst, NY 14228+716-691-0010
Date Prepared:	April 11, 2016
Proprietary Name:	Telio® CAD Multi
Classification Name:	Crown and Bridge, Temporary, Resin (872.3770)(Classification Code EBG)

Device Description: Telio CAD Multi are PMMA discs used for fabrication of long-term temporaries by means of CAD/CAM technology. The PMMA discs have a Long-term (12-month) wear period and durable shade stability with lifelike layered appearance. The device is available in 8 shades (BL2, A1, A2, A3, A3.5, A4, B1 and B2) and 4 thicknesses 12mm, 16mm, 20mm and 25mm. They are the standard 98.5 mm in diameter to permit use with the Wieland Select Milling equipment or other equipment which accepts 98.5 mm discs. The material exhibits high homogeneity due to industrial manufacturing process and temporaries can be easily reproduced using the CAD/CAM Technology. The device is contraindicated for use in permanent restorations and bridge designs involving more than two adjacent pontics. The device should not be used in patients with para-functional habits, ex. Bruxism or patients known to be allergic to the ingredients.

Indications for Use:

For manufacturing by a CAD/CAM system:

· Provisional anterior and posterior crowns with a maximum wear period of up to 12 months.

• Provisional anterior and posterior bridges with up to two adjacent pontics for a maximum wear period of up to 12 months.

• Provisional inlay and onlays

ZCAD Temp Esthetic (K132937) by Harvest Dental (Brea.CA) Predicate Device:

Secondary predicates for reference:

Idodentine (Dental Polymer Blank) (K150432) to support 12 month long term wear claim
Vipi Block (K102341) for composition and biocompatibility.

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510(K) SUMMARY

TelioCAD Multi
Rev April 11, 2016

Image /page/4/Picture/2 description: The image shows the logo for Ivoclar Vivadent. The logo is composed of the company name in blue, with the words "passion vision innovation" written in smaller letters below. Above the company name is a semi-circle of green and blue dots, with the green dots on the left and the blue dots on the right.

Indications for use

Predicate device (K132937)	Telio CAD Multi
510k clearance, Indications for UseStatement:"The Harvest Dental Polymer Blocks(ZCAD) are PMMA blanks for manufacturingtemporary crowns and bridges by aCAD/CAM system."	• Provisional anterior and posterior crownswith a maximum wear period of up to 12months.• Provisional anterior and posterior bridgeswith up to two adjacent pontics for amaximum wear period of up to 12 months.• Provisional inlay and onlays
Predicate device (K150432)	Telio CAD Multi
Time in mouth:Long term temporary (more than 30 days,less than 12 months)	Time in mouth:Long term temporary (more than 30 days,less than 12 months)

Principles of operation

Predicate device (K132937)	Telio CAD Multi
The blocks are processed by dental	The blocks are processed by dental
technicians using CAD/CAM technology to	technicians using CAD/CAM technology to
create temporary restorations.	create temporary restorations.

Device Description

Predicate device (K132937)	Telio CAD Multi
PMMA in the form of polymerized Disc for thefabrication of long-term temporaries bymeans of the CAD/CAM technology.	PMMA in the form of polymerized discs forthe fabrication of long-term temporaries bymeans of the CAD/CAM technology.
No accessories	No accessories
Product available in different thicknesses	Product available in four differentthicknesses 12mm, 16mm, 20mm and 25mm
Available in one translucency: LT	Available in one translucency: LT
Available in various shades:	Available in BL2, A1, A2, A3, A3.5, A4, B1,B2
Compatible with Wieland milling units or anyother units accepting 98.5mm discs whereopen architecture CAM is used in the design,i.e. 3Shape	Compatible with Wieland milling units or anyother units accepting 98.5mm discs whereopen architecture CAM is used in the design,i.e. 3Shape
The disc delivered unpolished	The subject device is polished on both thetop and bottom surfaces to a high gloss.This has no impact on the use, safety oreffectiveness of the device.

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510(K) SUMMARY

TelioCAD Multi

Rev April 11, 2016

Image /page/5/Picture/3 description: The image shows the logo for Ivoclar Vivadent. The logo consists of the company name in a sans-serif font, with "Ivoclar" in a slightly darker shade of blue than "Vivadent." Above the company name is a series of green and blue dots and squares arranged in an arc shape. The dots are on the left side of the arc and the squares are on the right side of the arc.

passion vision innovation

Predicate device (K132937)	Telio CAD Multi
The processing steps for the fabrication of	The processing steps for the fabrication of
the desired restoration are described in the	the desired restoration are described in the
Instructions for Use.	Instructions for Use.
Connector dimensions:	Connector dimensions:
with 1 pontic: at least 12 mm²	with 1 pontic: at least 12 mm²
with 2 pontics: at least 12 mm²	with 2 pontics: at least 12 mm²
Polishing, finishing, lining,	Polishing, finishing, lining,
Seating/cementation:	Seating/cementation:
Intra-oral cementation using a eugenol-free	Intra-oral cementation to tooth using a
temporary cement	eugenol-free temporary cement
Storage conditions: no special conditions	Storage conditions: no special conditions
Shelf life: no special conditions	Shelf life: no special conditions
Sterilization: Device is delivered non-sterile	Sterilization: Device is delivered non-sterile
and no sterilization is recommended for use.	and no sterilization is recommended for use.

Materials

Tachnology

Predicate device (K132937)	Telio CAD Multi
PMMA	PMMA

Standards

Predicate device (K132937)	Telio CAD Multi
The device was tested to ISO 10477:2004and ISO 20795-1 Dentistry – Base Polymers– Part 1: Denture base Polymers	The device was tested to ISO 10477:2004and ISO 20795-1 Dentistry – Base Polymers– Part 1: Denture base Polymers

Testing Summary: The subject device was not tested for Biocompatibility as no new elements are used in the chemical composition as compared to the predicate device. Biocompatibility evaluation was carried out according to ISO 10993-1 and ISO 7504. No changes have been made which will affect biocompatibility. The device was tested according to ISO 10477:2004 Dentistry - Polymer based crown and bridge materials for Surface finish, Flexural Strength, Bond strength, Water Sorption, Solubility, Shade Consistency and Color stability and the device met all requirements of the standard. The devices was also tested according to ISO 20795-1 :2013 Dentistry - Base Polymers - Part 1: Denture Base Polymers for5 Modulus of Elasticity and Residual monomer and the device met these requirements. Finally, testing according to ISO 179-1:2010 for Charpy toughness, ISO 180:2000 for izod impact strength and ISO 868:2003 for Vickers Hardness (converted from Shore D), was conducted to provide additional insight as to the properties of the materials for its intended use.

Conclusion: The above data and analysis demonstrates that Telio®CAD Multi is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.