Flash Penta™ MB Quick and Flash MB Quick are addition type silicone impression materials of medium consistency. Flash Penta MB Quick is mixed in the Pentamix mixing device, while Flash MB Quick can be applied directly using the Garant™ dispenser. Both products are used in mono-phase technique and in one-step technique.

AI/ML Overview

The provided text describes a 510(k) submission for dental impression materials (Flash Penta™ MB Quick and Flash MB Quick). It primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical properties. However, it does not contain the detailed information requested regarding acceptance criteria, study design for proving device acceptance, or any elements related to AI/algorithm performance.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about sample sizes, ground truth, experts, or MRMC studies as these are not mentioned in the provided document.

To be specific about what is mentioned:

Device: Flash Penta™ MB Quick and Flash MB Quick (VPS impression material).
Study Type: Bench testing.
Properties Evaluated: Consistency, total working time, detail reproduction, linear dimensional change, compatibility with gypsum type 3 / type 4, recovery from deformation and strain in compression.
Purpose: To demonstrate substantial equivalence to predicate devices (Flash Penta™ HB Q, Flash Heavy Body Q, Flash Regular Body Q, Flash Light Body) in terms of intended use, indications for use, composition, and physical properties.

The document states that a "biocompatibility assessment was developed... using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines" and concluded that the products are safe for their intended use. However, no specific details of this assessment's methods or results are provided.

In summary, the provided document does not contain the information necessary to fulfill your request for details on acceptance criteria, a study proving device acceptance, or any AI/algorithm-related performance metrics.

Summary

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Carl-Schurz-Straße 1 41453 Neuss Germany

Postal Address: ESPE Platz 82229 Seefeld Germany 金 +49 (0)8152 700-0 岛 +49 (0)8152 700-1366 Internet: www.3MESPE.de E-Mail: info3MESPE@3M.com WEEE-Reg.-Nr. DE 36963167 VAT-ID: DE 120679179

510(k) Summary

510(k) submitter:	3M Deutschland GmbHESPE Platz82229 SeefeldGermanyEstablishment Registration Number: 9611385
Contact Person	Ruediger FrankeRegulatory Affairs SpecialistPhone: +49-8152-700 1802Fax: +49-8152-700 1869e-mail: ruediger.franke@3M.com
Date:	March 05, 2014
Trade Name:	Flash Penta™ MB QuickFlash MB Quick
Common Name:	VPS impression material
Classification Name:	Impression material(21 CFR 872.3660, product code ELW)
Predicate Devices	Flash Penta™ HB Q (K120438)Flash Heavy Body Q (K120438)Flash Regular Body Q (K120438)Flash Light Body (K120438)

Description of Device

Image /page/0/Picture/11 description: The image contains a logo and some text. The logo is a circular design with a dot above it. The text reads "Deutsche Dental" and "Page 5 of 198". The text is located to the right of the logo.

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Indications for Use:

All types of impressions, e.g .:

· Crown, bridge, inlay, and onlay preparations

· Implants

· Orthodontic impressions

Substantial Equivalence

Information provided in this 510(k) submission shows that Flash Penta MB Quick and Flash MB Quick are substantially equivalent to the predicate devices Flash Penta HB Q, Flash Heavy Body Q. Flash Regular Body Q and Flash Light Body in terms of intended use, indications for use, composition and physical properties. A biocompatibility assessment was developed for Flash Penta MB Quick and Flash MB Quick using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines. The conclusion of the assessment is that Flash Penta MB Quick and Flash MB Quick are safe for their intended use.

This 510(k) submission includes data from bench testing to evaluate the performance of Flash Penta MB Quick and Flash MB Quick compared to predicate devices Flash Penta HB Q, Flash Heavy Body Q, Flash Regular Body Q and Flash Light Body. The properties evaluated include consistency, total working time, detail reproduction, linear dimensional v change, compatibility with gypsum type 3 / type 4, recovery from deformation and strain in compression.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or supporting another, represented by abstract shapes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

June 5, 2014

3M Deutschland GmbH Ruediger Franke Regulatory Affairs Specialist ESPE Platz Seefeld, Bavaria Germany 82229

Re: K140602

Trade/Device Name: Flash Penta™ MB Quick, Flash MB Quick Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 5, 2014 Received: March 10, 2014

Dear Mr. Franke:

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. Franke

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary's Runner -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K140602

Device Name Flash Penta MB Quick and Flash MB Quick

Indications for Use (Describe)

All types of impressions, e.g .:

· Crown, bridge, inlay, and onlay preparations

• Implants

· Orthodontic impressions

Type of Use (Select one or both, as applicable)

🇿 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

****************************************************************************************************************************************************************************** Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Sheena 2014.06.05

FORM FDA 3881 (1/14)

Page 1 of 2

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510(k) Submission: Flash Penta MB Quick & Flash MB Quick

3M Confidential

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).