← Product Code [EIH](/productcode/EIH) · K992489

# 3M TR SYSTEM (K992489)

_3M Company · EIH · Jan 11, 2000 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K992489

## Device Facts

- **Applicant:** 3M Company
- **Product Code:** [EIH](/productcode/EIH.md)
- **Decision Date:** Jan 11, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6660
- **Device Class:** Class 2
- **Review Panel:** Dental

## Indications for Use

The 3M™ TR System is a ceramic material. It is intended to be used by dental laboratories and dentists (with chair side dental milling units) to create specific restorations. This device is indicated for: Fabricating copings and frameworks for inlays, onlays, veneers, crowns and anterior bridge restorations.

## Device Story

3M™ TR System is a ceramic material used by dental laboratories and dentists with chair-side milling units; creates dental restorations including copings, frameworks, inlays, onlays, veneers, crowns, and anterior bridges. Device functions as raw material for milling; physical properties (compressive strength, fracture toughness, flexural strength) allow for creation of durable dental prosthetics. Used in clinical or laboratory settings; output is a custom-milled dental restoration. Benefits include restoration of tooth structure and function. Not for use in implants or patients with bruxism/clenching.

## Clinical Evidence

Bench testing only. Evidence consists of laboratory data comparing compressive strength, fracture toughness, and flexural strength of the 3M™ TR System against predicate devices, supplemented by published literature.

## Technological Characteristics

Ceramic material for dental milling. Properties validated via compressive strength, fracture toughness, and flexural strength testing. Intended for use with dental milling units.

## Regulatory Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

## Predicate Devices

- Vitabloc Mark II (not specified)
- In-Ceram Alumina (not specified)

## Submission Summary (Full Text)

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K 992489

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:          | 3M™ TR System                                                                             |
| Common Names:        | Porcelain mill block material, Alumina core material                                      |
| Classification Name: | 21 CFR § 872.6660 Porcelain powder for clinical use, Class II                             |

Vitabloc Mark II and In-Ceram Alumina both made by Vident Predicate Devices:

3M™ TR System is a ceramic material. It is intended to be used by dental laboratories and dentists (with chair side dental milling units) to create specific restorations.

The 3M™ TR System is indicated for copings and frameworks for inlay, onlay, veneer, crown and anterior bridge restorations. 3M™ TR System is not indicated as an implant material. The 3M™ TR System is not recommended for bruxers or clinchers.

3M™ TR System and predicate devices have similar technological characteristics. This has been validated by the comparing results of published laboratory data, along with 3M generated bench data. These tests include compressive strength, fracture toughness and flexural strength.

Based on the conclusions drawn from the safety information available on this material, past history with it's use, the results of the bench testing and published literature, the 3M™ TR 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 is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird or abstract shape, consisting of three curved lines that resemble wings or feathers.

Public Health Service

## 'JAN 1 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lael J. Pickett Regulatory Affairs Specialist 3M Center St. Paul, MN 55144-1000

Re: K992489 3MTM TR System Trade Name: Requlatory Class: II Product Code: EIH Dated: July 16, 1999 Received: July 26, 1999

Dear Mr. Pickett:

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 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 The general controls provisions of the Act 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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

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Page 2 - Mr. Pickett

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 (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" (21 CFR 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.fdaggov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timoth A. 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™ TR System System

Indications For Use: This device is indicated for:

- Fabricating copings and frameworks for inlays, onlays, veneers, crowns and anterior bridge . restorations
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Susan Runne

(Division Sign-Off) Division of Dental, Infection Contr and General Hospi 510(k) Number

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**Source:** [https://fda.innolitics.com/device/K992489](https://fda.innolitics.com/device/K992489)

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