IMAGINE H.E. PRESS DESIGN-CERAMIC

K020774 · Wieland Dental + Technik GmbH & Co. KG · EIH · May 22, 2002 · Dental

Device Facts

• Record ID: K020774
• Device Name: IMAGINE H.E. PRESS DESIGN-CERAMIC
• Applicant: Wieland Dental + Technik GmbH & Co. KG
• Product Code: EIH · Dental
• Decision Date: May 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IMAGINE h.e. Press Design-Ceramic is a dental porcelain that can be used by dental technicians for the fabrication of metal free all-ceramic dental restorations. IMAGINE h.e. Press Design-Ceramic is intended for manufacturing: - Metall-free single unit restorations in the anterior region and posterior region up to . the second premolar, - O, MO, or MOD inlays and . - Onlays, and veneers .

Device Story

Dental porcelain system for fabricating metal-free all-ceramic restorations; consists of pre-shaded ceramic ingots. Dental technicians process ingots in a ceramic press furnace to create single unit restorations, inlays, onlays, and veneers. Designed for use in dental laboratories. Final restorations are placed by dentists to restore tooth structure. Benefits include aesthetic, metal-free dental reconstruction.

Clinical Evidence

Bench testing only. Device meets or exceeds ISO 6872 standards for Type 2, Class 1 dental ceramics.

Technological Characteristics

Type 2, Class 1 dental ceramic per ISO 6872. Material: Pre-shaded ceramic ingots (pellets). Processing: Ceramic press furnace. CTE designed for compatibility with IMAGINE h.e. Ceramic layering/staining materials.

Indications for Use

Indicated for dental technicians to fabricate metal-free all-ceramic single unit restorations in anterior and posterior regions (up to second premolar), O/MO/MOD inlays, onlays, and veneers.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

K020774

## Premarket Notification 510(k)

IMAGINE h.e. Press Design-Ceramic

510 (k) Summary

Device description

IMAGINE h.e. Press Design-Ceramic is a dental porcelain system, which provides an easy to use and aesthetically pleasing material to fabricate metal-free, all-ceramic dental restorations. It consists of pre-shaded ceramic ingots, which had to be processed in a ceramic press furnace by the dental technicians.

According to ISO 6872, IMAGINE h.e. Press Design-Ceramic is a Type 2, Class 1 dental ceramic, which meets the demands of this standard and even exceeds most given limits.

IMAGINE h.e. Press Design-Ceramic can be used for manufacturing metal-free allceramic single unit restorations in the anterior region and posterior region up to the second premolar, O-, MO- or MOD- inlays, onlays, and veneers.

The Coefficient of Thermal Expansion (CTE) of IMAGINE h.e. Press Design-Ceramic pellets were designed to be exactly compatible with the Coefficient of Thermal Expansion of IMAGINE h.e. Ceramic. Therefore IMAGINE h.e. Ceramic should be used exclusively for the layering or staining techniques.

IMAGINE h.e. Press Design-Ceramic is market and clinically applicated in Europe, particularly in Germany, since February, 2001.

The IMAGINE h.e. Press Design-Ceramic assortment consists of the following ingots (pellets):

| Type of the Pellet | Amount | Shades |
|-------------------------------------------------|---------------------|------------------------------------------------------------------------------------------------------|
| Pellets Naturescence [N] | 16 different shades | [NA1] [NA2] [NA3] [NA3,5] [NA4] [NB1] [NB2] [NB3]<br>[NB4] [NC1] [NC2] [NC3] [NC4] [ND2] [ND3] [ND4] |
| Pellets Basic | 16 different shades | [A1] [A2] [A3] [A3,5] [A4] [B1] [B2] [B3] [B4] [C1] [C2]<br>[C3] [C4] [D2] [D3] [D4] |
| Pellets Naturescence<br>Bleaching [NBL] | 4 different shades | [NBL A01] [NBL A02] [NBL B01] [NBL B02] |
| Pellets Basic Bleaching [BL] | 4 different shades | [BL A01] [BL A02] [BL B01] [BL B02] |
| Transparency Pellets Staining<br>Technique [MT] | 11 different shades | [MT01] [MT02] [MT 1] [MT 2] [MTC0] [MTC1] [MTC2]<br>[MTC3] [MTC4] [MTC5] [MTweiß] |
| Intensive, opaceous Dentine<br>pellets [loD] | 4 different shades | [ioD A] [ioD B] [ioD C] [ioD D] |

{1}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle.

#### Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2002

Mr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Company Schwenninger Strabe 13 Forzheim, GERMANY D-75179

Re: K020774

Trade/Device Name: IMAGINE h.e. Press Design-Ceramic Regulation Number: 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: II Product Code: EIH Dated: March 8, 2002 Received: March 11, 202

Dear Mr. Gerhard Polzer:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{2}------------------------------------------------

Page 2 - Mr. Gerhard Polzer

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4613. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Tim A. Ulatowski

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

Enclosure

{3}------------------------------------------------

Premarket Notification 510(k)

## IMAGINE h.e. Press Design-Ceran

K 020774

# 4. Statement of indication for use

IMAGINE h.e. Press Design-Ceramic is a dental porcelain that can be used by dental technicians for the fabrication of metal free all-ceramic dental restorations.

IMAGINE h.e. Press Design-Ceramic is intended for manufacturing:

- Metall-free single unit restorations in the anterior region and posterior region up to . the second premolar,
- O, MO, or MOD inlays and .
- Onlays, and veneers .

The official form for the "Indication for Use Statement" developed by the Office of Device Evaluation is given as Annex K

Susan Rump

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _