3M DENT II SYSTEM

K981647 · 3M Company · EBF · Aug 9, 1998 · Dental

Device Facts

• Record ID: K981647
• Device Name: 3M DENT II SYSTEM
• Applicant: 3M Company
• Product Code: EBF · Dental
• Decision Date: Aug 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

3M Dent II System is a visible-light activated, radiopaque restorative material based on monomer chemistry (TEGDMA and BISGMA). Used by dentists in clinical settings for direct and indirect dental restorations. Applied in conjunction with a dental adhesive system. Material provides structural restoration for anterior and posterior teeth. Performance validated through bench testing of shrinkage, diametral tensile strength, compressive strength, wear, hardness, and depth of cure. Output is a cured, tooth-colored resin restoration.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing comparing physical properties (shrinkage, diametral tensile strength, compressive strength, wear, hardness, and depth of cure) against predicate devices.

Technological Characteristics

Visible-light activated, radiopaque restorative material. Composition based on TEGDMA and BISGMA monomer chemistry. Form factor is a dental restorative resin. No software or electronic components.

Indications for Use

Indicated for patients requiring direct or indirect anterior and posterior dental restorations, including Class I-VI restorations, veneers, incisal edge repair, cusp buildups, core buildups, splinting, inlays, and onlays.

Regulatory Classification

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.

Predicate Devices

• 3MTM Z100TM Restorative
• Prisma TPHTM Spectrum
• XRVTM Herculite®
• AlertTM
• SureFilTM

Submission Summary (Full Text)

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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. Pickett<br>Regulatory Affairs Specialist |
|----------------------|----------------------------------------------------------------------------------------------|
| Address: | 3M Dental Products Laboratory<br>3M Center, Building 260-2B-12<br>St. 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<br>(21 CFR §872.3690) |
| Predicate Devices: | 3MTM Z100TM Restorative<br>Prisma TPHTM Spectrum<br>XRVTM Herculite®<br>AlertTM<br>SureFilTM |

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)

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