3M M.G. MATERIAL by 3M COMPANY | FDA 510(k) Summary

3MTM M.G. Material is designed to make fast, accurate, and rigid interocclusal records. The material has a consistency which resists slumping and offers minimal resistance to closure to ensure proper occlusion. 3M™ M.G. Material may also be used as a matrix material when fabricating custom temporary crowns and bridges. It is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto the occlusal surfaces of the teeth. The material quickly cures into a rigid impression.

AI/ML Overview

The provided documentation (K981325) is a 510(k) summary for a dental product, 3M™ M.G. Material. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and bench test results.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based device with performance metrics like sensitivity, specificity, or AUC.

The product described is a physical dental material (bite registration material), not a software or AI/ML device that would typically involve a test set, ground truth, experts, or MRMC studies. The "performance" discussed relates to material properties through bench tests.

Therefore, many of the requested categories are not applicable to the provided document. I will fill in what information is available and indicate when requested information is not present.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Bench Test: Strain in Compression	Not explicitly stated as numerical criteria, but implied to be comparable to or better than predicates.	Compared to predicate devices.
Bench Test: Detail Reproduction	Not explicitly stated as numerical criteria, but implied to be comparable to or better than predicates.	Compared to predicate devices.
Bench Test: Mixed Consistency	Not explicitly stated as numerical criteria, but implied to be comparable to or better than predicates.	Compared to predicate devices.
Bench Test: Linear Dimensional Change	Not explicitly stated as numerical criteria, but implied to be comparable to or better than predicates.	Compared to predicate devices.
Overall Safety & Effectiveness	"safe, effective, and performs as well or better than the predicate devices."	"Based on the safety analysis and the bench tests, 3M™ M.G. Material is safe, effective, and performs as well or better than the predicate devices."

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

Not Applicable. This document describes the testing of a physical dental material, not an AI/ML device. Bench tests were performed, but no "test set" in the context of data for an algorithm is mentioned.

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)

Not Applicable. No ground truth established by experts is mentioned, as this is a physical material tested via bench methods.

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

Not Applicable. No adjudication method for a "test set" (in the context of AI/ML data) is described.

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

No. An MRMC study was not done. This product is a dental impression material, not an AI-assisted diagnostic tool.

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

Not Applicable. This product is a physical dental material, not an algorithm.

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

Not Applicable / Bench Test Standards. The "ground truth" for the bench tests would be the established scientific and engineering standards and methods used to measure material properties. There's no clinical "ground truth" (like pathology or expert consensus) relevant here.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable. There is no "training set" or "ground truth" in this context.

Summary

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3M Dental Products Laboratory

3M Center, Building 260-2B-09 St. Paul, MN 55144-1000 612 733 3149

Jun | | 1998

K98 1325

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Name:	Amy E. Fowler
Address:	3M Dental Products Laboratory3M Center, Building 260-2B-12St. Paul, MN 55144-1000
Phone:	(612) 736-1590
Fax:	(612) 736-0990
E-mail:	aefowler@mmm.com
Date:	April 10, 1998
Trade Name:	3MTM M.G. Material
Common Names:	Bite registration material, occlusal registration material
Classification Name:	Impression material(21 CFR 872.3660) Class II
Predicate devices:	3MTM ImprintTM II Vinyl Impression Material System3MTM Fast Set Bite Registration MaterialHeraeus Kulzer MemoregTM C.D. Bite Registration MaterialParkell Blu-Mousse® AutoMix Cartridges

3MTM M.G. Material is designed for making impressions that record the occlusal relationship of the upper and lower dental arches. It is also intended to be used as a matrix when fabricating temporary crowns and bridges. The predicate devices do not specifically say they are intended for use as matrices. However, the labeling for temporary crown and bridge materials has indirectly indicated the predicate devices for this use for many years. This use does not present any new issues of safety or efficacy.

3MTM M.G. Material and the predicate devices have similar technological characteristics as indicated by their vinyl polysiloxane addition-cure chemistry. This is further validated by the comparative results of the bench tests conducted, including strain in compression, detail reproduction, mixed consistency, and linear dimensional change.

Based on the safety analysis and the bench tests, 3MTM M.G. Material is safe, effective, and performs as well or better than the predicate devices.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a stacked formation. The profiles are connected and appear to be part of a single, flowing shape. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN | | 1998

Ms. Amy E. Fowler · Regulatory Affairs 3M Dental Products Laboratory 3M Center, Building 260-2B-09 St. Paul, Minnesota 55144-1000

Re : K981325 3M M.G. Material Trade Name: Regulatory Class: II Product Code: ELW Dated: April 10, 1998 Received: April 13, 1998

Dear Ms. Fowler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Fowler

through 542 of the Act for devices under the Electronic Chrough 542 of the not al provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sia wi puivalence of your device to a legally marketed predicate device results in a classification for your marketed produces ormits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ... ......

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510(k) Number:

Device Name: 3M™ M.G. Material

Indications For Use:

Indications I or Ose. material when fabricating custom temporary crowns and bridges.

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

and the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Susan Runver
	(Division Sign-Off)
Division of
and General Hospital Devices
510(k) Number	K98 825

Prescription Use	(Per 21CFR 801.109)
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OR
Over-the Counter Use

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).