Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, endentulous and partial impression.

The Flexitime Fast & Scan range of products are prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials, such as the 3 shape D700 laser scanners.

Device Description

Flexitime Fast & Scan Impression Materials are addition-cross-linking polyvinyl siloxane materials. The Flexitime Fast & Scan Impression Materials family consists of Light Flow, Medium Flow, Dynamix Putty, Easy Putty and Dynamix Heavy Tray. Flexitime Light Flow, Medium Flow, Heavy Tray are delivered in 50 ml cartridges while Flexitime Fast & Scan Dynamix Putty and Dynamix Heavy Tray are delivered in 380 ml Cartridges and Flexitime Fast & Scan Easy Putty is delivered in a 300 ml container.

The Flexitime Fast & Scan assortment is characterized by the addition of Titanium Dioxide (in order to ensure scannability) and is technically characterized by an extra-oral working time of up to 1.5 minutes and a short time in mouth of 2.0 minutes. The materials were developed to ensure hydrophilic characteristics for optimal impression taking in the wet surroundings of the mouth combined with good mechanical properties. Also, they ensure scannability with state of the art red laser light impression scanners.

Flexitime Fast & Scan products are part of the Flexitime System.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Heraeus Flexitime Fast & Scan Impression Materials:

Upon review of the provided 510(k) summary, it's immediately apparent that this document describes a dental impression material, not a medical device in the typical sense of a software-driven diagnostic or imaging tool. As such, many of the requested categories for AI-based device studies (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not applicable to this type of product.

This 510(k) is focused on demonstrating substantial equivalence to predicate devices based on physical properties, biocompatibility, and intended use as an impression material. The "study" referenced is primarily a non-clinical evaluation against established ISO standards and a clinical evaluation based on the existing scientific literature and technical results for similar products.

Here's a breakdown of the requested information, noting where it is not applicable (N/A):

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Reported Device Performance (Flexitime Fast & Scan)
Material Properties:	A. Physical Properties (Implied Equivalence to Standards)
Scannability	Can be prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials (e.g., 3shape D700 laser scanners). Achieved by the addition of Titanium Dioxide. This enables scannability without prior powdering, which is required for the predicate device, Flexitime Fast and Scan (K102770).
Extra-oral Working Time	Up to 1.5 minutes.
Time in Mouth	2.0 minutes.
Hydrophilic Characteristics	Ensures optimal impression taking in the wet surroundings of the mouth.
Mechanical Properties	Good mechanical properties.
ISO Compliance	The physical properties of the additional Flexitime Fast& Scan assortments (Dynamix Heavy Tray and Easy Putty) are like Flexitime Fast and Scan (K102770) and Flexitime (K000629) products, and are in compliance with ISO 4823. The new assortment is also claimed to be like the original Flexitime Fast & Scan (K102770) in this regard.
B. Biocompatibility:	Verified in accordance with international standards, specifically FDA recognized standard EN ISO 10993-1. A biocompatibility evaluation report documented this, concluding a positive benefit/risk relation and equivalence to the predicate device's safety.
C. Clinical Performance:	Based on a critical evaluation of scientific data and technical results, the products are expected to exhibit the claimed technical performance. Potential undesirable clinical effects and risks are well controlled and accepted, leading to a positive benefit versus risk ratio for dentistry when applied according to instructions. This also contributes to the conclusion of substantial equivalence to the predicate device in terms of safety and clinical benefits. The device has the same indications for use, warnings, and contraindications as the predicate device.
D. Risk Analysis:	A risk analysis was carried out, concluding that the safety of Flexitime Fast & Scan for its intended use is substantially equivalent to the predicate device.

Study Details (Applicability to this type of device)

Sample size used for the test set and the data provenance:
- Not Applicable (N/A) in the context of an AI device. This 510(k) does not describe a study involving a "test set" of patient data for diagnostic accuracy like an AI algorithm would. Instead, performance is assessed through material property testing and reference to standards.
- For Biocompatibility: "The biological compatibility of Flexitime Fast & Scan was verified in accordance with the international standards." This implies testing on biological models or in-vitro tests, but specific sample sizes or provenance of test samples are not detailed in this summary.
- For Material Properties: Testing of physical properties (working time, setting time, hydrophilicity, mechanical properties, scannability) would involve batches of the material itself, tested in laboratory settings. Details on the number of samples tested for each property are not provided in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. There isn't a "ground truth" establishment in the sense of expert annotation of medical images for an AI algorithm.
- For the Clinical Evaluation: The document mentions "experts" stating a positive benefit-risk ratio for Flexitime Fast & Scan, and a "toxicologist" performed the biocompatibility evaluation. Specific numbers and detailed qualifications beyond "toxicologist" and "experts" are not provided. These are likely experts in dental materials science and toxicology, respectively.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This concept applies to expert consensus in AI model validation, not to the testing of physical properties or biological compatibility of a dental impression material.
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:
- N/A. This is completely irrelevant for a dental impression material. There are no "human readers" or "AI assistance" in the context described in this 510(k).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is a material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A (in the AI context).
- For material properties: The "ground truth" would be established by validated test methods specified in standards like ISO 4823.
- For biocompatibility: The "ground truth" is defined by the criteria within ISO 10993-1.
- For clinical evaluation: The "ground truth" is based on existing scientific data and accepted dental practices for impression materials, leading to an expert-judged benefit-risk assessment rather than a direct patient outcome study of the device itself.
The sample size for the training set:
- N/A. This concept is for machine learning models and does not apply to a physical impression material.
How the ground truth for the training set was established:
- N/A. This concept is for machine learning models and does not apply to a physical impression material.

Summary of the Device's "Study" Approach:

The "study" for this device, as detailed in the 510(k) summary, is primarily a non-clinical evaluation against recognized international standards for dental impression materials (ISO 4823 for physical properties, ISO 10993-1 for biocompatibility) and a clinical evaluation that critically assesses scientific data and technical results to confirm expected performance and a favorable benefit-risk profile. The crucial aspect for its FDA clearance is demonstrating substantial equivalence to existing legally marketed predicate devices, particularly regarding its physical properties (adherence to ISO standards), biocompatibility, and intended use, with an added feature of scannability without powdering.

Summary

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Heraeus

510(k) Summary

JUL 25 2012

510(k) summary of safety and effectiveness information for Flexitime Fast & Scan in accordance with 21 CFR 807.92.

1. Submitter Information

Company Name:	Heraeus Kulzer, LLC
Company Address:	300 Heraeus WaySouth Bend, IN 46614
Company Phone:	(574) 299-5421

Contact Person: Jamie Mearna

Date Summary prepared: December 28, 2011(Revised June 29, 2012)

2. Device Identification

Trade /Proprietary Name:

Flextime Fast & Scan Impression Materials to include
- Flexitime Fast & Scan Light Flow �
- ◆ Flexitime Fast & Scan Medium Flow,
- Flexitime Fast & Scan Dynamix Putty �
- . Flexitime Fast & Scan Easy Putty
- Flexitime Fast & Scan Dynamix Heavy Tray .

Common Name:	Material, Impression (21 CFR 872.3660)
Classification:	Class II
FDA Code:	Dental ELW.

3. Legally Market Devices to which Substantial Equivalence is claimed:

Heraeus Kulzer, GmBH - Flexitime Impression Material (K000629) Heraeus Kulzer, GmBH - Flexitime Fast & Scan Impression Material (K102770)

4. Device Description

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taking in the wet surroundings of the mouth combined with good mechanical properties. Also, they ensure scannability with state of the art red laser light impression scanners.

Flexitime Fast & Scan products are part of the Flexitime System.

5. Intended Use

Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown & bridges, endentulous and partial impressions.

6. Technological Characteristics

The physical properties of the additional Flexitime Fast& Scan assortments: Dynamix Heavy Tray and Easy Putty are like Flexitime Fast and Scan (K102770) and Flexitime (K000629) products in the fact that they are also in compliance with ISO 4823.

The new assortment of Flextime Fast and Scan materials (like the original Flexitime Fast & Scan K102770) can be prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials.

7, Nonclinical Testing

The biological compatibility of Flexitime Fast & Scan was verified in accordance with the international standards.

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

8. Clinical Testing

In accordance with US FDA Medical Device Regulations, any medical device is required to be evaluated by the legal medical device manufacturer regarding its clinical performance and c variation by the regal nical evaluation, which is intended to critically evaluate the clinical benefits of the medical device in comparison to tis potential risks. Therefore, any clinical benefits of the medical compulsory risk management process according to FDA recognized evaluation 15 part of the son critical findings must further be considered in the current risk Standard, int process of the medical device manufacturer responsible for the evaluated device.

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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 Flextime Fast & Scan 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 Flexitime Fast & Scan assortment, provided that the products are applied in accordance with the intended use as outlined in the manufacturer's instructions for use.

9. Summary of Conclusion

The new Flexitime Fast & Scan assortment is substantially equivalent to the original Flexitime Fast & Scan and Flexitime. All of the products are indicated for taking impression materials of suited techniques. In addition, the new assortment of Flexitime Fast & Scan is scannable without prior powdering as is required with the predicate device, Flexitime Fast and Scan.

A biocompatibility evaluation has been performed by a toxicologist for Flextime Fast & Scan, and it was confirmed that the product meets the requirements of FDA recognized standard, ISO 10993 Standard and it was concluded that the safety of Flexitime Fast & Scan is equivalent to that of the predicate device.

The risk analysis was carried out for Flexitime Fast & Scan and it was concluded that the safety of the Flexitime Fast & Scan device, for the intended use, is substantially equivalent to the predicate device. Flexitime Fast & Scan and the predicate device both have the same indications for use, warnings and contraindications.

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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 & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

JUL 25 2012

Mr. Jamie Mearna Quality Assurance & Regulatory Associate Heraeus Kulzer, LLC 300 Heraeus Way South Bend, Indiana 46614

Re: K120914

Trade/Device Name: Flexitime Fast & Scan Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 09, 2012 Received: July 11, 2012

Dear Mr. 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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Page 2 - Mr. Mearna:

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 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/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 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 vours.

For

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

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K/26 914

Device Name: Flexitime Fast & Scan

Indications for Use:

Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, endentulous and partial impression.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


	(Division Sign-Off)
	Division of Anesthesiology, General Hospital
	Infection Control, Dental Devices
10(k) Number:	K120914

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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).