Xantasil is a medium flow, addition-curing, elastomer dental impression material that can be used to cover all impression needs where a traditional alginate material would be used, such as impressions for temporaries, crown and bridges, removable dentures, orthodontic models, opposing jaw models, splints, mouth guards and bleaching trays. It is used to get a negative copy of the patients' dental situation.

Device Description

Xantasil is an addition-curing polyvinyl-siloxane impression material. Xantasil is delivered in 50 ml and 380 ml cartridges. Xantasil is an optimized A-silicone impression material with medium consistency meant as a replacement for alginates. The mouth removal time for the product is 1.5 minutes Xantasil is for use in the Dynamix automatic dispensing and mixing system and the 1:1 Cartridge dispenser.

AI/ML Overview

The provided text describes a 510(k) submission for a dental impression material named Xantasil. The submission focuses on demonstrating substantial equivalence to predicate devices based on physical properties, not on a study with AI in a diagnostic context. Therefore, many of the requested fields are not applicable to this document.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (Predicate Devices based on ISO 4823)	Reported Device Performance (Xantasil)
Working Time	≥2:30 min	≥2:30 min
Detail Reproduction	≤20 µm	≤20 µm
Linear Dimensional Change	≤1.5%	≤1.5%
Compatibility to Gypsum	≤20 µm	≤20 µm
Strain in Compression	≤20%	≤20%

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

Not applicable. This is a dental impression material, and the "test set" here refers to the physical properties measured against ISO 4823 standards for dental materials, not a patient-based test set for an AI device. The document does not specify sample sizes for these physical property tests or data provenance beyond "in compliance with ISO 4823."

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. Ground truth as typically understood for AI/diagnostic devices doesn't apply here. The "experts" mentioned in the document are involved in judging the benefit/risk ratio, not establishing ground truth for a test set.

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

Not applicable.

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

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI algorithm.

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

For the physical properties, the "ground truth" is defined by the technical specifications and test methods outlined in ISO 4823 for dental impression materials.
For the biological compatibility, "bridging data from predicates in accordance with the international standard ISO 10993-1" was used.

8. The sample size for the training set

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

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

Not applicable.

Summary

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K130647

Heraeus

510(k) Summary according to 21 CFR 807.92(c)

MAY 1 7 2013

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Submitter Information:
Name	Heraeus Kulzer, LLC
Address	300 Heraeus WaySouth Bend, IN 46614
Phone Number	(574) 299-5421
Fax Number	(574) 291-0080
Establishment Registration Number	1925223
Name of Contact Person	Jamie Meama
Date Prepared	December 31, 2012
Name of Device:
Trade or Proprietary Name	Xantasil
Common or Usual Name	Impression Material
Classification Name	Dental ELW
Device Classification	Class II
Classification Panel:	76 Dental
Regulation:	21 CFR 872.3660
Product code (s):	ELW
Legally marketed devices(s) to whichequivalence is claimed:	Flexitime K000629Flexitime Monophase Pro Scan K113574
Reason for 510(k) Submission:	This submission is to notify FDA of an optimizedA-silicone impression material with mediumconsistency meant as a replacement for alginates.
Device Description:
	Xantasil is an addition-curing polyvinyl-siloxaneimpression material. Xantasil is delivered in 50 mland 380 ml cartridges.Xantasil is an optimized A-silicone impressionmaterial with medium consistency meant as areplacement for alginates.The mouth removal time for the product is 1.5minutesXantasil is for use in the Dynamix automaticdispensing and mixing system and the 1:1 Cartridgedispenser.
Indications for use:
	Xantasil is a medium flow, addition-curing,elastomer dental impression material that can beused to cover all impression needs where atraditional alginate material would be used, such asimpressions for temporaries, crown and bridges,removable dentures, orthodontic models, opposingjaw models, splints, mouth guards and bleachingtrays. It is used to get a negative copy of thepatients' dental situation.

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Image /page/1/Picture/0 description: The image shows the word "Heraeus" in a bold, outlined font. The letters are slightly distressed, giving the word a textured appearance. The word is presented in a horizontal orientation, filling the majority of the frame.

Summary of the Technological Characteristics of the New Devices Compared to the Predicate Devices Flexitime Monophase K000629 & Flexitime Monophase K113574:

The physical properties of Xantasil like Flexitime Monophase (K000629) and Flexitime Monophase ProScan (K113574) are in compliance with ISO 4823.

Similarities as Compared to Predicates:

Attribute	Xantasil	Monophase K000629	Monophase Pro Scan K113574
FDA Code	ELW	ELW	ELW
Mixing Time,handspatulated	n.a.	n.a.	n.a.
Working Time	≥2:30 min	≥2:30 min	≥2:30 min
DetailReproduction	≤20 µm	≤20 µm	≤20 µm
LinearDimensionalChange	≤1,5%	≤1,5%	≤1,5%
Compatibilityto Gypsum	≤20 µm	≤20 µm	≤20 µm
Strain inCompression	≤20%	≤20%	≤20%

Differences as Compared to Predicate:

No difference in technological characteristics.

Results Summary:

Xantasil is substantially equivalent to Flexitime Monophase ProScan and Flexitime Monophase. All of the products are indicated for taking impression materials of suited techniques.

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Image /page/2/Picture/0 description: The image shows the word "Heraeus" in a stylized font. The letters are outlined with a thick border, giving them a bold appearance. The font is sans-serif and appears to be a custom design.

Conclusions Drawn From Non-Clinical and Clinical Data:

The biological compatibility of Xantasil was verified utilizing bridging data from predicates in accordance with the international standard ISO 10993-1.

The biocompatibility of Xantasil in the aforementioned indication was documented in a biocompatibility evaluation report and the benefit/risk relation has been judged as positive.

The clinical evaluation is intended to critically evaluate the clinical benefits of the medical device in comparison to its potential risks. Therefore, any clinical evaluation is part of the compulsory risk management process according to EN ISO 14971, and critical findings must further be considered in the current risk management process of the medical device manufacturer responsible for the evaluated device.

On this background, the clinical evaluation was performed. This critical evaluation followed the procedures outlined in the corresponding clinical evaluation plan.

Considering the evaluated scientific data and technical results for Xantasil it is concluded that the products can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and accepted, when weighed against their benefit to dentistry. Therefore, a positive benefit versus risk ratio can be stated by the experts for Xantasil, provided that the products applied in accordance with its intended use as outlined in the manufacturer's instructions for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

May 17, 2013

Ms. Jamie Mearna Associate Quality Assurance/Regulatory Affairs Manager Heraeus Kulzer, Limited Liability Company · 300 Heraeus Way SOUTH BEND IN 46614

Re: K130647

Trade/Device Name: Xantasil Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 7, 2013 Received: March 20, 2013

Dear Ms. Mearna:

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Digitally signed by Mary S. Runner
DN: C=US, O=U.S. Government,
OU=HHS, OU=FDA, ou=People,
Susan Runner, DDS, MA O=Mary S. Runner -S.
00
0.9.2342.19200300.100.1.1=13000
950/

for

Anthony D. Watson, B.S., M.S., M.B.A. 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 1306

510(k) Number (if known):

Device Name: Xantasil

Indications for Use:

Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) S. Runner -S 013:04.24 07:37:07

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K130647

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).