(72 days)
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Not Found
No
The device description is for a dental porcelain material and its intended use in fabricating dental restorations. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
This device is a dental porcelain material used by dental technicians to fabricate "all-ceramic dental restorations," such as crowns, inlays, onlays, and veneers, which are replacements for missing or damaged tooth structure. It is a material used in the creation of a therapeutic device rather than being a therapeutic device itself.
No
The device is a dental porcelain system used for fabricating dental restorations (e.g., veneers, inlays), which are used for treatment or correction, not for diagnosis.
No
The device description clearly states it is a "dental porcelain system" consisting of "pre-shaded ceramic ingots" which are processed in a "ceramic press furnace". This describes a physical material and a process involving hardware, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The IMAGINE h.e. Press Design-Ceramic is a dental porcelain used by dental technicians to fabricate dental restorations (crowns, inlays, onlays, veneers). It is a material used in the mouth, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for manufacturing dental restorations, not for diagnosing or monitoring a medical condition.
- Device Description: The description details the material composition and processing method for creating dental prosthetics. It does not describe a diagnostic test.
Therefore, the IMAGINE h.e. Press Design-Ceramic falls under the category of a dental material or prosthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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 .
Product codes
EIH
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] [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] [C3] [C4] [D2] [D3] [D4] |
| Pellets Naturescence 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 Technique [MT] | 11 different shades | [MT01] [MT02] [MT 1] [MT 2] [MTC0] [MTC1] [MTC2] [MTC3] [MTC4] [MTC5] [MTweiß] |
| Intensive, opaceous Dentine pellets [loD] | 4 different shades | [ioD A] [ioD B] [ioD C] [ioD D] |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior region and posterior region up to the second premolar
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
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.(b)
Classification. Class II.
0
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] |
| [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] |
| [C3] [C4] [D2] [D3] [D4] | ||
| Pellets Naturescence | ||
| 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 | ||
| Technique [MT] | 11 different shades | [MT01] [MT02] [MT 1] [MT 2] [MTC0] [MTC1] [MTC2] |
| [MTC3] [MTC4] [MTC5] [MTweiß] | ||
| Intensive, opaceous Dentine | ||
| 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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 _