(36 days)
Imagine h.e. is a dental porcelain that is used by dental technicians to fabricate infagine mor 10 a metal or to press-ceramic restorations. It is suitable for veneering alloys with a high coefficient of thermal expansion [CTE(25 - 500°C): 16.1-16.7 x 10°K']], alleyo www ed restorations, and heat-pressed ceramic frameworks made of the Imagine h.e. Press-Ceramic.
Imagine h.e. can be used for veneering of inlays, partial crowns, crowns, and bridges.
Imagine h.e. is a dental porcelain. It provides an easy to use and aesthetically pleasing dental restorative material to fabricate dental restorations. With its naturescent, brilliant shade effect, Imagine h.e. offers the dental technicians optimum conditions for achieving an exact reproduction of natural teeth.
Imagine h.e. is a dental glass-ceramic containing of leucite crystals (< 4 µm). Its firing temperature range lies between 820°C and 730°C
Originally developed for veneering dental alloys with high coefficient of thermal expansion [CTE (25-500°C): 16.1 -16.7 x 10°K'] in the porcelain fused to metal technique, the range of indication of the Imagine h.e. has been extended to veneering of electroformed restorations made of AGC -Galvanogold and of Imagine h.e. pressceramic (Wieland Edelmetalle GmbH & Co.).
Imagine h.e. can be used for manufacturing inlays, partial crowns, crowns and bridges in the anterior as well as in the posterior region.
Imagine h.e. is market and clinically applicated in Europe, especially in Germany since March, 1999.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a dental porcelain product (Imagine h.e.), detailing its description, classification, and indications for use, along with official correspondence from the FDA confirming substantial equivalence to a predicate device. It does not include performance data or studies against specific acceptance criteria as would be typical for a device with measurable performance metrics.
Therefore, I cannot provide the requested information in the table or address the subsequent points about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
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AUG 1 6 2001
Premarket Notification 510(k)
Imagine h.e.
5. 510 (k) Summary
Submitter of 510(k):
Wieland Edelmetalle GmbH & Co. Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0
Contact person: Phone: Fax: e-mail:
Dr. Gerhard Polzer +49-7231-3705-219 +49-7231-357959 gerhard.polzer@wieland-dental.de
2001-06-21 Date of Summary:
Trade name:
Imagine h.e.
Classification name: Product code: C.D.R section: Classification:
Porcelain powder for clinical use ElH 872.6660 Class II
Legally marketed Duceragold equivalent device:
K931808 510(k) number:
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Premarket Notification 510(k)
510 (k) Summary
Device description
Imagine h.e. is a dental porcelain. It provides an easy to use and aesthetically pleasing dental restorative material to fabricate dental restorations. With its naturescent, brilliant shade effect, Imagine h.e. offers the dental technicians optimum conditions for achieving an exact reproduction of natural teeth.
Imagine h.e. is a dental glass-ceramic containing of leucite crystals (< 4 µm). Its firing temperature range lies between 820°C and 730°C
Originally developed for veneering dental alloys with high coefficient of thermal expansion [CTE (25-500°C): 16.1 -16.7 x 10°K'] in the porcelain fused to metal technique, the range of indication of the Imagine h.e. has been extended to veneering of electroformed restorations made of AGC -Galvanogold and of Imagine h.e. pressceramic (Wieland Edelmetalle GmbH & Co.).
Imagine h.e. can be used for manufacturing inlays, partial crowns, crowns and bridges in the anterior as well as in the posterior region.
Imagine h.e. is market and clinically applicated in Europe, especially in Germany since March, 1999.
| Type of Powder | Shades |
|---|---|
| Paste opaque | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4 |
| Colour paste opaque | White, Violet, Orange, Brown |
| Opaque dentine | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4 |
| Dentine | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4 |
| Enamel Opal | SO57; SO58; SO59; SO60 |
| Transparent | Clear; Opal; Blue; White; Yellow; Red; Orange; Grey |
| Shoulder porcelains margin | M1; M2; M3; M4; M5; M6; M7; M8; M9; M10 |
| Dentine modifier | A; B; C; D; Orange; White |
| Mamelon modifier | Vanilla; Apricot; Sand; Lemon |
| Stains Colours | White; Orange; Olive; Blue; Brown; Black; Yellow; Violet; Chestnut; Grey |
| Glaze | GL |
| Correction | KD; KS |
| Gingiva | GV1 |
Imagine h.e. consists of the following porcelain powders:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2001
Mr. Gerhard Polzer Director of Regulatory Affairs Wieland Edelmetalle GMBH & Company Schwenninger Strabe 13 Pforzheim, GERMANY
K012156 Re : Imagine H.E. Trade/Device Name: Regulation Number: 872.6660 II Requlatory Class: Product Code: EIH Dated: July 1, 2001 Received: July 11, 2001
Dear Mr. Polzer:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beceies. In we have determined the market the device forly equivalent (for the indications for device is subscancially organ to legally marketed predicate use stated in the cherobate, or onmerce prior to May 28, 1976, devices marketed in interbead of the Medical Device Amendments, or to the enactment acc or the vasified in accordance with the devices that have been recrabblican recrain the separal provisions of the reachar room, subject to the general rou may, cherefore, of the Act. The general controls controls provisions of include requirements for annual provisions of the nee instevices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II II your device is crabbiria (socorres (social), it may (Special Controls) of Stimal controls. Existing major be subject to such addrois.device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ rederal kegulations, from to, mination assumes compliance with subscancially equivalence aring Practice requirements, as set the Current Souality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodic Q2) will verify such assumptions. Failure to Administration (FMP regulation may result in regulatory Compry with the one - FDA may publish further announcements
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Page 2 - Mr. Polzer
concerning your device in the Federal Register. Please note: concerning your device in the immonification submission does this response to your premaines is a many sections 531 not afrect any obligation you might the Electronic through 542 of the net 101 xeviews, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as This lecter will arrow your on researce notification. The FDA described in your from prematice of your device to a legally
finding of substantial equivalence of your device for your marketed predicate device results in a classification for your marketed predicate device robares in the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.00 for in regulation (21 crk vices), please contact the Office of Villo diagnoscic deviceb/, proade of of questionally, for questions on Compilance at (501) dvertising of your device, please contact the Dromotion and adversibility of Journal (1301) Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). _ Other general premation on your responsibilities under the Act may be Informacion on your in Division of Small Manufacturers obtained Trom the Division of Charlese at its toll-free number International and combams 13-6597 or at its internet address ('000') </searda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Olin S-Lof
Timotky A. Ulatowski
Timothy A. Ülat Director Infection Control Division of Dental, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification 510(k)
Imagine h.e.
4. Statement of indication for use
lmagine h.e. is a dental porcelain that is used by dental technicians to fabricate infagine mor 10 a metal or to press-ceramic restorations. It is suitable for veneering alloys with a high coefficient of thermal expansion [CTE(25 - 500°C): 16.1-16.7 x 10°K']], alleyo www ed restorations, and heat-pressed ceramic frameworks made of the Imagine h.e. Press-Ceramic.
Imagine h.e. can be used for veneering of inlays, partial crowns, crowns, and bridges.
McCulloch for MSR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number_
§ 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.