Flash Bite is classified as impression materials (21 C.F.R. § 872.3660) because it is a devices intended to reproduce the structure of a patient's teeth. Flash Bite is a two component (base paste/catalyst) vinyl polysiloxane bite registration material designed to be used in 3M Deutschland GmbH's mixing, dosing and dispensing device, Garant of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 1:1 (by volume).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental impression material named "Flash Bite." This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of indications for use, physical and mechanical properties, and chemical composition, rather than presenting a study with acceptance criteria and device performance in the typical sense of a diagnostic medical device.

Therefore, many of the requested elements for a study establishing acceptance criteria do not apply directly to this type of submission. However, I will extract what can be inferred or directly stated from the document regarding equivalence testing.

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" for quantitative performance metrics in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices in terms of properties. The performance is assessed against the existing, legally marketed predicate devices.

Property (Implicit Acceptance Criteria)	Reported Device Performance (Flash Bite)
Indications for Use	Substantially equivalent to predicate devices (Bite registration)
Physical Properties	Compared to predicate devices; deemed substantially equivalent
Mechanical Properties	Compared to predicate devices; deemed substantially equivalent
Chemical Composition	Compared to predicate devices; deemed substantially equivalent
Biocompatibility	Biocompatible for its intended use (as per FDA & internationally recognized guidelines)

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

The document does not specify sample sizes for any tests. The data provenance is not mentioned beyond the submitting company being located in Germany. The nature of the comparisons (e.g., laboratory tests) suggests prospective data collection for the new device, but this is not explicitly stated.

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)

This is not applicable. For material equivalence, ground truth is established through standardized material testing methods and comparison to known properties of predicate materials, not through expert reader consensus on clinical images or data.

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

This is not applicable as the submission is for material equivalence based on physical, mechanical, and chemical properties, and biocompatibility, not clinical diagnostic performance requiring adjudication of results.

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 is not applicable. The device is a dental impression material, not an AI-powered diagnostic tool. Therefore, no MRMC study was conducted.

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

This is not applicable as the device is a material, not an algorithm.

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

The "ground truth" in this context is the established performance characteristics and safety profile of the predicate devices, along with adherence to recognized biocompatibility standards. For the physical, mechanical, and chemical properties, the ground truth would be the values obtained from standardized material testing. For biocompatibility, it's compliance with FDA and international guidelines.

8. The sample size for the training set

This is not applicable as the device is a dental material, not a machine learning model, and therefore does not have a "training set."

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

This is not applicable for the same reason as point 8.

Summary

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MAR - 6 2014

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter

Company:	3M Deutschland GmbH
Street:	ESPE Platz
ZIP-Code, City:	82229 Seefeld
Federal State:	Bavaria
Country:	Germany
Establishment Registration Number	9611385
Official Correspondent:	Dr. Desi W. Soegiarto,Regulatory Affairs Specialist
Phone Official Correspondent:	+49-8152-700 1169
Fax Official Correspondent:	+49-8152-700 1869
E-mail Official Correspondent:	desi.soegiarto@mmm.com
Contact Person	Ruediger Franke,Regulatory Affairs Specialist
Phone Contact Person:	+49-8152-700 1802
Fax Contact Person:	+49-8152-700 1869
E-mail Contact Person:	ruediger.franke@3M.com
Date:	October 29, 2013

Name of Devices

Proprietary Name:	Flash Bite
Classification Name:	Impression material
Common Name:	Vinyl polysiloxane bite registration material

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Predicate Devices

Dimension Biteby 3M Deutschland GmbH, Germany	K991008
Flash AR Pentaby 3M Deutschland GmbH, Germany	K131404

Description for the Premarket Notification

Flash Bite is classified as impression materials (21 C.F.R. § 872.3660) because it is a devices intended to reproduce the structure of a patient's teeth.

Flash Bite has been developed based on Dimenson Bite of 3M Deutschland GmbH (K991008), a predicate device to which Flash Bite has been compared. Like Dimension Bite, Flash Bite is a two component (base paste/catalyst) vinyl polysiloxane bite registration material designed to be used in 3M Deutschland GmbH's mixing, dosing and dispensing device, Garant of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 1:1 (by volume).

In this 510(k) premarket notification Flash Bite has been compared to the predicate devices Dimenson Bite of 3M Deutschland GmbH (K991008) and Flash AR Penta of 3M Deutschland GmbH (K131404) with regard to indications for use, physical and mechanical properties, and chemical composition. The comparison for indications for use, performance data, and chemistry shows that Flash Bite is substantially equivalent to the predicate devices.

Biocompatibility testing was carried out. Biocompatibility evaluations have been performed for Flash AR Bite in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Flash Bite material is biocompatible for its intended use.

In summary, it can be concluded that Flash Bite is as substantially equivalent in safety and effectiveness as the predicate devices Dimension Bite and Flash AR Penta by 3M Deutschland GmbH.

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Indications for Use:

· Bite registration

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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 feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

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

March 6, 2014

3M Deutschland GmbH Dental Products Mr. Ruediger Franke Regulatory Affairs ESPE Platz D-82229 Seefeld GERMANY

Re: K133400

Trade/Device Name: Flash Bite Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 11, 2013 Received: December 13, 2013

Dear Mr. Ruediger:

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. Ruediger

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.

Image /page/4/Picture/7 description: The image shows the text "Erin Keith -S". The text is in a bold, sans-serif font. The words "Erin" and "-S" are in a simple, blocky font, while the word "Keith" is stylized with a more complex, geometric design. The overall impression is a combination of simplicity and complexity.

Erin I. Keith, M.S. Acting Division 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): K133400

Device Name: Flash Bite

Indications For Use: Bite registration.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mages Runner -5
Sean Runyon 2014.03.06
10:02:23 -05'00'

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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).