Flash materials 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 will be available as wash and tray materials. The wash materials will be available in one viscosity (light-bodied), each of them in a regular set and a super-quick set version. The tray materials will be available in two different viscosities (putty and heavy-bodied) in a regular set and a super-quick set version.

As the predicate devices, Flash materials are two component (base paste/catalyst) vinyl polysiloxane impression materials designed either to be used in 3M Deutschland GmbH's mixing, dosing and dispensing device, Garant™, or to automatically be mixed and dispensed in the Pentamix™ device of 3M Deutschland GmbH.

AI/ML Overview

This 510(k) summary does not contain the level of detail necessary to complete all sections of your request. It's a summary of substantial equivalence to predicate devices, rather than a detailed report of a study proving specific performance metrics against acceptance criteria.

However, I can extract the information that is present and indicate where details are missing.

Description of Acceptance Criteria and Device Performance

This 510(k) summary asserts the device's "substantial equivalence" to three predicate devices (Future Wash/YPS, Dimension Penta H, and 3M ProPlus System) rather than presenting specific acceptance criteria and performance data for the Flash materials themselves. The basis for equivalence relies on:

Indications for Use: Flash materials are indicated for "all precision impressions" similar to the predicate devices.
Physical and Mechanical Properties: The document states that Flash was compared to the predicate devices regarding these properties, showing "substantial equivalence." However, no specific performance metrics or acceptance criteria for these properties (e.g., tear strength, dimensional stability, setting time) are provided.
Chemical Composition: Flash's chemical composition is described as similar to the predicate devices (two-component vinyl polysiloxane impression materials).
Biocompatibility: Biocompatibility testing was carried out, and the conclusion was that Flash materials are biocompatible for their intended use. No specific acceptance criteria or results are detailed.

Therefore, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values from this document. The "acceptance criteria" are implicitly "being substantially equivalent to the predicate devices."

Study Details

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, not typically a detailed study report with specific performance data against explicit acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance:

Feature/Property	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Indications for Use	Same as predicate devices	Indicated for "all precision impressions (of e.g.: crown, bridge, inlay and onlay preparations)," which is stated as equivalent to predicate devices.
Physical & Mechanical Properties	Similar to predicate devices (specific values not stated)	Comparison showed "substantial equivalence" to predicate devices. No specific quantitative data provided.
Chemical Composition	Similar to predicate devices	Two-component (base paste/catalyst) vinyl polysiloxane impression materials, designed for 3M Deutschland GmbH's mixing devices (Garant™, Pentamix™), similar to predicate devices.
Biocompatibility	Meets internationally recognized guidelines and risk assessment for intended use	Biocompatibility assessments concluded that Flash materials are biocompatible for their intended use. No specific test results or criteria provided.
Safety & Effectiveness	Substantially equivalent to predicate devices	Concluded to be "substantially equivalent in safety and effectiveness" to predicate devices (Future Wash/YPS K051797, Dimension Penta H K000591, 3M ProPlus System K963766).

Sample size used for the test set and the data provenance: Not specified in this 510(k) summary. The document mentions "performance data" was used for comparison but does not detail the sample sizes for any tests. The data provenance would likely be internal testing by 3M Deutschland GmbH (Germany).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. For a dental impression material, ground truth is typically based on objective physical/chemical measurements rather than expert consensus on, for example, image interpretation.
Adjudication method for the test set: Not applicable/Not specified.
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 device is a dental impression material, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental impression material, not an algorithm.
The type of ground truth used: For physical and mechanical properties, "ground truth" would be established by standardized testing methods and measurement instruments, yielding objective data (e.g., tensile strength in MPa, dimensional change in percentage). For biocompatibility, it would be based on recognized testing standards (e.g., ISO 10993 series) and expert toxicological assessment. The document does not detail these test results.
The sample size for the training set: Not applicable. This device is a dental impression material; there is no "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Summary

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1/120438

MAY - 2 2012

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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:	February 10. 2012

Name of Device

Proprietary Name: ............................................................................................................................................................

Flash Penta™ HB SQ Flash Penta™ HB Q Flash Heavy Body SQ Flash Heavy Body Q Flash Regular Body SQ Flash Regular Body Q Flash Light Body SQ Flash Light Body Q Flash Ultra-Light Body SQ Flash Penta™ Putty

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Classification Name:	Impression material
Common Name:	Dental impression material

Predicate Devices

Future Wash/YPS by 3M Deutschland GmbH, Germany ......... K051797 Dimension Penta H by 3M Deutschland GmbH, Germany ....... K000591 3M ProPlus System by 3M ESPE Dental Products, U.S.A. ....... K963766

Description for the Premarket Notification

Flash materials 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.

In this 510(k) premarket notification Flash has 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 is substantially equivalent to the predicate devices.

Biocompatibility testing was carried out. Biocompatibility assessments were developed for Flash using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Flash materials are biocompatible for its intended use.

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In summary, it can be concluded that Flash is as substantially equivalent in safety and effectiveness as the predicate devices Future Wash/YPS by 3M Deutschland GmbH, Germany (K051797), Dimension Penta H by 3M Deutschland GmbH, Germany (K000591), and 3M ProPlus System by 3M ESPE Dental Products, U.S.A. (K963766).

Indications for Use:

Flash VPS Impression Materials are indicated to be used for all precision impressions (of e.g .: crown, bridge, inlay and onlay preparations).

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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 consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. 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

Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M Deutschland GmbH ESPE Platz D-8229 Seefeld GERMANY

Re: K120438

Trade/Device Name: Flash Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: February 10, 2012 Received: February 13, 2012

Dear Dr. Soegiarto:

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.

MAY - 2 2012

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Page 2 - Dr. Soegiarto

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 yours,

Clintons

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

< 120 438

Flash

510(k) Number (if known):

Device Name:

Indications For Use:

Flash VPS Impression Materials are indicated to be used for all precision impressions (of e.g.: crown, bridge, inlay and onlay preparations).

× Prescription Use (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)

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

ใ Page 1 of

510(k) Submission: Flash

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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).