3M DENT II SYSTEM

• K Number: K981647
• Device Name: 3M DENT II SYSTEM
• Manufacturer: 3M COMPANY
• Date Cleared: 1998-08-09 ( 90 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: K120453 , K151094

Intended Use

Indications:

• • Direct anterior restorations including:
    • Class III, IV, V, and VI 1
    • Veneers ー
    • Incisal edge repair -
• • Direct posterior restorations including:
    • Class I or II l
    • Sandwich technique with glass ionomer resin material l
    • -Cusp Buildups
• • Core Buildups
• ★ Splinting
• Indirect anterior and posterior restoration including: ★
  • -Inlays
  • Onlays -
  • Veneers

Device Description

3M™ Dent II System is a visible-light activated, radiopaque restorative material. This device, as well as the predicate devices, are based on monomer chemistry.

AI/ML Overview

The 3M™ Dent II System is a tooth shade resin material used for dental restorations. The provided 510(k) summary focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than establishing novel performance criteria through extensive clinical studies with specific acceptance criteria in the context of AI/software device evaluation. Therefore, many of the requested categories are not directly applicable or explicitly detailed in this type of submission for a physical dental material.

Here's an attempt to extract and infer information relevant to your request based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the 3M™ Dent II System are implicitly set by its performance being "as well or better than the predicate devices" across various physical and chemical properties. The study conducted to prove this involves bench tests comparing the new device against several predicate devices.

Acceptance Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance	Comments
Material Chemistry	Similar TEGDMA and BISGMA monomer chemistry to 3M™ Z100™ Restorative, Prisma TPH™ Spectrum, and XRV™ Herculite®	Has similar TEGDMA and BISGMA monomer chemistry	The device shares fundamental chemical composition with key predicates.
Shrinkage	Performance "as well or better than" predicate devices	Validated by comparative results of bench tests	Specific performance values are not provided, only that it was compared and found acceptable.
Diametral Tensile Strength	Performance "as well or better than" predicate devices	Validated by comparative results of bench tests	Specific performance values are not provided, only that it was compared and found acceptable.
Compressive Strength	Performance "as well or better than" predicate devices	Validated by comparative results of bench tests	Specific performance values are not provided, only that it was compared and found acceptable.
Wear	Performance "as well or better than" predicate devices	Validated by comparative results of bench tests	Specific performance values are not provided, only that it was compared and found acceptable.
Hardness	Performance "as well or better than" predicate devices	Validated by comparative results of bench tests	Specific performance values are not provided, only that it was compared and found acceptable.
Depth of Cure	Similar depth of cure to Alert™ and SureFil™	Validated by laboratory bench tests	Specific performance values are not provided, only that it was compared and found acceptable.
Safety	No new or increased safety concerns compared to predicate devices	Safety analysis conducted, supports device safety	This is a general safety assessment for the device material.
Effectiveness	Performs "as well or better than" predicate devices	Results of bench testing support effectiveness	This refers to its ability to function as an effective restorative material.

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Study Details

The provided document describes a 510(k) submission, which primarily relies on bench testing to demonstrate substantial equivalence for a physical medical device (dental restorative material). It is not a clinical study involving human subjects or an AI/software device. Consequently, many of the requested categories related to AI/software evaluation (test set size, ground truth, experts, MRMC studies, standalone performance, training set) are not applicable or detailed in this context.

Here's an analysis based on the information available:

1. Sample size used for the test set and the data provenance: Not applicable in the context of "test set" for AI. The "tests" here refer to bench tests of material properties. The sample sizes for these physical property tests are not specified in this summary. The data provenance would be from 3M's internal laboratory, presumably in the USA. These are prospective tests conducted on manufactured samples of the device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the AI sense does not apply to the physical properties being measured in bench tests. The measurements themselves (e.g., shrinkage, strength, hardness) are the "truth" derived from standardized testing methods.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is for resolving discrepancies in expert labeling or diagnoses, which is not relevant for bench testing of material properties.

4. 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 is not an AI-assisted device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the bench tests, the "ground truth" is established by standardized laboratory measurement methods for physical and chemical properties (e.g., methods for measuring shrinkage, tensile strength, compressive strength, wear, hardness, depth of cure). These are objective measurements rather than subjective expert consensus or pathology.

7. The sample size for the training set: Not applicable. This is a physical device, not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

Summary

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K981647

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:	Lael J. PickettRegulatory Affairs Specialist
Address:	3M Dental Products Laboratory3M Center, Building 260-2B-12St. Paul, MN 55144-1000
Telephone:	612-733-3594
Fax:	612-736-0990
Trade Name:	3MTM Dent II System
Common Names:	Tooth shade resin material
Classification Name:	Tooth shade resin material(21 CFR §872.3690)
Predicate Devices:	3MTM Z100TM RestorativePrisma TPHTM SpectrumXRVTM Herculite®AlertTMSureFilTM

3M™ Dent II System is a visible-light activated, radiopaque restorative material. This device, as well as the predicate devices, are based on monomer chemistry.

3M™ Dent II System is used in conjunction with a dental adhesive system for both anterior and posterior restorations. The predicate devices, when taken as a whole, have the same intended uses.

3M™ Dent II System II and 3M™ Z100™ Restorative, Prisma TPH™ Spectrum and XRV™ Herculite® devices have similar technological characteristics as indicated by their TEGDMA and BISGMA monomer chemistry. This is further validated by the comparative results of the bench tests conducted. These tests include shrinkage, diametral tensile strength, compressive strength, wear and hardness.

3M ™ Dent II System and Alert™, SureFil™ have similar depth of cure based on laboratory bench tests conducted.

Based on the conclusions drawn from the safety analysis conducted for this device and the results of the bench testing, 3M™ Dent II System is safe, effective and performs as well or better than the predicate devices mentioned above.

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Image /page/1/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 human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 1998

Ms. Rebecca L. Hannack Regulatory Affairs 3M Dental Products Laboratory 3M Center, Building 260-2B-12 St. Paul, Minnesota 55144-1000

Re : K981647 3M™ Dent II System Trade Name: Requlatory Class: II Product Code: EBF Dated: May 7, 1998 Received: May 11, 1998

Dear Ms. Hannack:

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 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.

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੈਂ 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 action. In addition, FDA may publish further announcements 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. Hannack

through 542 of the Act for devices under the Electronic Product Radiation Control 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 finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address

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

Sincerely yours,

S. Detmer for

Timothy A. Ulatowski 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 (if known):

Device Name: 3M Dent II System

Indications For Use:

Indications:

• • Direct anterior restorations including:
    • Class III, IV, V, and VI 1
    • Veneers ー
    • Incisal edge repair -
• • Direct posterior restorations including:
    • Class I or II l
    • Sandwich technique with glass ionomer resin material l
    • -Cusp Buildups
• • Core Buildups
• ★ Splinting
• Indirect anterior and posterior restoration including: ★
  • -Inlays
  • Onlays -
  • Veneers

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runney

(Division Sign Off) Division of Donal Infection Control, and General Hospital Devices KG XIII 4 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

:

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Page X

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.