Flash AR Penta™ and Flash AR Penta™ Quick are classified as impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth. Flash AR Penta™ and Flash AR Penta™ Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 5:1 (by volume).

AI/ML Overview

The provided 510(k) summary describes a dental impression material (Flash AR Penta™ and Flash AR Penta™ Quick), not an AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria for AI performance, clinical studies with human readers, and ground truth establishment is not applicable to this submission.

However, I can extract the relevant information about the device and its demonstrated equivalence.

Nature of the Device:
The device is described as "medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions." It is a two-component vinyl polysiloxane impression material.

Equivalence Claim:
The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices (Position Penta™ & Position Penta™ Quick, and Flash materials by 3M Deutschland GmbH) based on indications for use, physical and mechanical properties, and chemical composition.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a dental impression material, the "acceptance criteria" and "reported device performance" are primarily related to physical and mechanical properties, chemical composition, and biocompatibility rather than diagnostic performance metrics like sensitivity or specificity. The submission states that these properties were compared to predicate devices.

Acceptance Criteria Category	Reported Device Performance (as demonstrated by comparison to predicate)
Indications for Use	Substantially equivalent to predicate devices.
Physical Properties	Substantially equivalent to predicate devices.
Mechanical Properties	Substantially equivalent to predicate devices.
Chemical Composition	Substantially equivalent to predicate devices.
Biocompatibility	Materials are biocompatible for intended use, evaluated per FDA & internationally recognized guidelines.

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

Test Set Sample Size: Not explicitly stated. The comparison against predicate devices involved evaluating physical and mechanical properties, chemical composition, and biocompatibility. The specific number of samples tested for each property is not detailed in the summary.
Data Provenance: The device manufacturer (3M Deutschland GmbH) is located in Germany. Biocompatibility evaluations considered FDA and internationally recognized guidelines, implying data generated adheres to these standards. The comparison studies would have been conducted by the manufacturer as part of the submission package. The data is retrospective in the sense that it evaluates the device's properties against established benchmarks and predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. For a dental impression material, "ground truth" in the context of diagnostic accuracy (like in AI studies) is not relevant. The evaluation relies on standardized material testing (e.g., ISO standards) and chemical analysis.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists) when establishing ground truth for diagnostic AI. This device does not involve such a process. Material testing results are typically objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is designed for evaluating the impact of AI assistance on human reader performance in diagnostic tasks. This is a material, not a diagnostic AI device.

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

No. This is not an AI algorithm. Its performance is evaluated through material science testing.

7. The Type of Ground Truth Used

For this device, the "ground truth" refers to accepted standards for material properties, chemical composition, and biocompatibility. This would involve:
- Standardized Material Testing: Adherence to relevant ISO standards (e.g., for impression materials) for properties like tear strength, dimensional stability, working time, setting time, etc.
- Chemical Analysis: Verification of the chemical composition against the formulation and comparison to predicate devices.
- Biocompatibility Standards: Compliance with ISO 10993 series for medical device biocompatibility, which involves tests like cytotoxicity, sensitization, and irritation.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device, so there is no "training set." The materials are formulated and manufactured, then tested.

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

Not Applicable. As there is no training set for an AI model, this question does not apply. The development of the material is based on chemical and polymer science principles, with iterative formulation and testing, rather than an AI training paradigm.

Summary

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(

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAY 3 0 2013

Submitter

Company:	3M Deutschland GmbH
Street:	ESPE Platz
ZIP-Code, City:	D-82229 Seefeld
Federal State:	Bavaria
Country:	Germany
Establishment Registration Number	9611385
Official Correspondent:	Dr. Desi W. Soegiarto,Regulatory Affairs Specialist
Phone:	+49-8152-700 1169
Fax:	+49-8152-700 1869
E-mail:	desi.soegiarto@mmm.com
Date:	March 06, 2013

Name of Devices

Proprietary Name:	Flash AR Penta™
Classification Name:	Impression material
Common Name:	Dental impression material

Predicate Devices

Position Penta TM & Position Penta TM Quick
by 3M Deutschland GmbH, Germany	K974231
Flash
by 3M Deutschland GmbH, Germany	K120438

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Description for the Premarket Notification

Flash AR Penta™ and Flash AR Penta™ Quick are classified as impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth.

Flash AR Penta™ and Flash AR Penta™ Quick have been developed based on Position Penta™ and Position Penta™ Quick of 3M Deutschland GmbH (K974231), predicate devices to which Flash AR Penta™ and Flash AR Penta™ Quick have been compared. As the predicate devices Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 5:1 (by volume).

In this 510(k) premarket notification Flash AR Penta™ and Flash AR Penta™ Quick have been compared to the predicate devices 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 AR Penta™ and Flash AR Penta™ Quick are substantially equivalent to the predicate devices.

Biocompatibility testing was carried out. Biocompatibility evaluations have been performed for Flash AR Penta™ and Flash AR Penta™ Quick in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Flash AR Penta™ and Flash AR Penta™ Quick materials are biocompatible for its intended use.

In summary, it can be concluded that Flash AR Penta™ and Flash AR Penta™ Quick are as substantially equivalent in safety and effectiveness as the predicate devices Position Penta™ & Position Penta™ Quick by 3M Deutschland GmbH, Germany (K974231) and Flash materials by 3M Deutschland GmbH, Germany (K120438).

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Indications for Use:

· Impressions for the production of temporary restorations
All types of preliminary impressions .
Impressions of the opposing jaw .
Impressions for orthodontic models .

5 10(k) Submission: Flash AR Penta & Flash AR Penta Quick; March 06, 2013

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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 consists of a stylized caduceus symbol, which features three intertwined strands and a base resembling a wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Public Health Service

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

May 30, 2013

3M Deutschland GmbH C/O Mr. Alexander Schapovalov TUV SUD America, Incorporated 1775 Old Highway 8 North West NEW BRIGHTON MN 55112-1891

Re: K131404

Trade/Device Name: Flash AR Penta™, Flash AR Penta™ Quick Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 13, 2013 Received: May 23, 2013

Dear Mr. Schapovalov:

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. Schapovalov

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 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/ResourcesforYou/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

	Digitally signed by Mary S. Runner -SON: C=US, O=U.S. Government,OU=HHS, OU=FDA, ou=People,cn=Mary S. Runner -5,0.9.2342.19200300.100.1.1=13000879
	Susan Runner, DDSMA
	Date: 2013.05.30 10:37:12 -04'00'

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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1.5 Statement of Indications for Use

Indications for Use

510(k) Number (if known):	K131404
---------------------------	---------

Device Name:

Flash AR Penta™ Flash AR Penta™ Quick .

Indications For Use:

. Impressions for the production of temporary restorations
All types of preliminary impressions .
Impressions of the opposing jaw .
Impressions for orthodontic models .

Prescription Use (Part 21 CFR 301 Subpart D)	X
----------------------------------------------	----------

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)

Digitally signed by Mary S. Runner -S

DN: c=US; o=U.S. Government, ou=HHS,

ou=FDA, ou=People, cn=Mary S. Runner

0.9.2342.19200300.100.1.1=1300087950

Date: 2013.05.30 10:35:04 -04'00'

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	KB1404
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Page 1 of	1
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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).