(17 days)
Allux® is a dental silicate-glass ceramic that can be used by dental technicians to fabricate all-ceramic restorations by veneering aluminium oxide (Al₂O₃) frameworks.
The coefficient of thermal expansion [CTE (25 - 500°C)] of these aluminium oxide (Al₂O₃) frameworks had to equal approximately 8.0 x 10˚K¹ .
Allux® is a dental porcelain system that consists of 127 different ceramic powders.
It is intended to be used by professional dental technicians to manufacture all-ceramic dental appliances for the sole use of particular patients.
Allux® is recommended for veneering alumina oxide (Al₂O₃) frameworks, in which it provides an easy to use dental restorative material to fabricate dental restorations with the best possible aesthetic results.
The coefficient of thermal expansion [CTE (Algos) of these alumina oxide (Al₂O ) frameworks had to be approximately 8 x 10 ° K ¹.
Allux meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic".
The provided text is a 510(k) summary for a dental porcelain system called Allux. It describes the device, its intended use, and its classification, but it does not contain a study or data proving the device meets specific acceptance criteria in the way a typical medical device study would.
Instead, the submission states that "Allux meets all applicable requirements of the standard ISO 6872: 1995 'Dental ceramic'". This implies that the acceptance criteria are defined by this international standard for dental ceramics, and the device has been tested against these criteria.
Therefore, many of the requested details about a study, such as sample size, data provenance, expert adjudication, MRMC studies, or specific ground truth methodologies, are not present in this type of regulatory submission. These details would typically be found in a more detailed testing report or clinical study, which are not included in this 510(k) summary.
Here's an attempt to answer the questions based only on the provided text, acknowledging where information is missing:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by ISO 6872: 1995 "Dental ceramic". The document states that "Allux meets all applicable requirements" of this standard. Without the standard itself, specific numerical acceptance criteria cannot be listed.
| Acceptance Criteria (Defined by ISO 6872: 1995 "Dental ceramic") | Reported Device Performance |
|---|---|
| Specific criteria from ISO 6872: 1995 (e.g., flexural strength, chemical solubility, thermal expansion compatibility, aesthetics, etc.) | Meets all applicable requirements of ISO 6872: 1995 |
Note: The actual numerical criteria would need to be extracted from the ISO 6872: 1995 standard itself, which is not provided here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document does not detail the specific testing methodologies or the data collected to demonstrate compliance with ISO 6872.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Given that the compliance is with an international standard for material properties, "expert ground truth" in the clinical sense is not directly applicable here. The "ground truth" would be the measured physical properties of the ceramic, compared against the standard's specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically used in clinical studies involving interpretation, which is not the primary focus of demonstrating compliance with a material properties standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study is not applicable and was not done as described in this document. This typically applies to AI-assisted diagnostic devices. The Allux system is a dental porcelain material, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to this device. The Allux system is a dental porcelain material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be the measured physical and chemical properties of the Allux ceramic powders and fabricated restorations, as defined and tested according to the methodologies outlined in ISO 6872: 1995. This is typically determined through laboratory testing rather than clinical expert consensus or pathology in the traditional sense.
8. The sample size for the training set
This information is not applicable and not provided. The Allux system is a material, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no "training set" for this material device.
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Premarket Notification 510 (k) Allux
Image /page/0/Picture/1 description: The image shows the logo for WIELAND Dental + Technik. The word "WIELAND" is in large, bold, black letters. Below it, in smaller letters, are the words "Dental + Technik."
Wieland Dental + Technil GmbH & Co. KG Schwenninge: Storbe 13 D=75179 Pictubers
Pagtoner 10:2 4: D 7812 Marrie 1. . . . . . . .
5. 510 (k) Summary
FEB 1 4 2005
Wieland Dental + Technik GmbH & Co. KG Submitter of 510(k): Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0
Contact person: Dr. Gerhard Polzer +49-7231-3705-219 Phone: +49-7231-357959 Fax: e-mail: gerhard.polzer@wieland-dental.de
2005-01-20
Date of Summary:
Trade name:
,
Allux®
Classification name: Product code: C.D.R section: Classification:
Porcelain powder for clinical use દામ 872.6660 Class II
Legally marketed equivalent device:
Procera All-Ceramic Porcelain
510(k) number:
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Premarket Notification 510 (k) Allux
Image /page/1/Picture/1 description: The image shows the word "WIELAND" in large, bold, black letters. Below "WIELAND" is the phrase "Dental + Technik" in a smaller, thinner font. The text is centered.
Wieland Dental - Tacknis ( mhH X (
.
510 (k) Summary
Device description
Allux® is a dental porcelain system that consists of 127 different ceramic powders.
It is intended to be used by professional dental technicians to manufacture all-ceramic dental appliances for the sole use of particular patients.
Allux® is recommended for veneering alumina oxide (Al₂O₃) frameworks, in which it provides an easy to use dental restorative material to fabricate dental restorations with the best possible aesthetic results.
The coefficient of thermal expansion [CTE (CTE (CTE (Algos) of these alumina oxide (Al2O ) frameworks had to be approximately 8 x 10 ° K ¹.
Allux meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic".
| Type of Powder | Shades |
|---|---|
| Liner | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4;White, Yellow, Violet, Orange, Brown, Gum |
| Dentine | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4;Crystal 1 light; Crystal 2 pearl; Crystal 3 creme; Gum 1; Gum 2; Gum 3;Gum 4, Gum 5 |
| Chroma-Dentine Chromatix | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4 |
| Dentine Modifier | Mocca; Corn; Mango; Caramel; Khaki; Brown; Yellow; Ivory; |
| Flu-Dentines | Flamingo; Straw; Bright; Sunny; Crystal; |
| Incisal / Enamel | Incisal 1, Incisal 2, Incisal 3; Incisal 4;Topas; Anthrazit; Amethist; Aquamarin; Citrin; Rubin; Lemon; Melon;Transpa Neutral; Transpa Clear |
| Opale incisal | Opale Incisal 1, Opale Incisal 2, Opale Incisal 3, Opale Incisal 4,Crystal Blue, Frosty, Milky, Snow, Ice |
| Shoulder porcelains margin | High Flu, High 1, High 2, High 3, High 4, High Red, High Crystal;Low Flu, Low 1, Low 2, Low 3, Low 4, Low 5, Low Bleach |
| Stain | White; Black; Grey; Caramel; Orange; Ocker; Peach; Melon; Blue; Steel;Violet; Gum; Marone; Olive; Ivory; Yellow;Bodystain A; Bodystain B; Bodystain C; Bodystain D |
| Glaze | Glaze |
| Correction | Correction |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2005
Gerhard Polzer, Ph.D. Director, Regulatory Affairs Wiełand Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 D-75179 Pforzheim GERMANY
Re: K050203
Trade/Device Name: Allux® Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 20, 2005 Received: February 01, 2005
Dear Dr. Polzer:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your bookers in (-) f releved above and nave to legally marketed predicate devices marketed in interstate commerce ass stated in the encreated of the Medical Device Amendments, or to devices that prof to thay 20, 1978, and cordance with the provisions of the Federal Food, Drug, and Cosmetic have been rocussion of a premarket approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manot the detimely de requirements for annual registration, listing of devices, good controls provibitions or and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de nee is classified (600 ac on) also regulations affecting your device can be Inay of subject to saol adaments. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Gerhard Polzer, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease be advised mark 1 Dr. 3 toballio or build on a lovice complies with other requirements of the Act or that FDA nade a decemination that your case your case agencies. You must comply with CEP Posses of ally Federal statutes and regulations animals in the do: registration and listing (21 CFR Part 807); an the Act 3 requirements, mortains, vanitacturing practice requirements as set forth in the quality labeling (21 CFR Part 801), good manazing 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) I ms letter will unow you to organization of substantial equivalence of your device to a legally prematics notification. - The Privation 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), please If you desire specific acrieviller at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other Misoranianting of reference to promaibilities under the Act from the Division of Small general international on your responsibilition in its toll-free number (800) 638-2041 or Manufacturers, international and octoss http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suon Ruari
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN):
Allux® DEVICE NAME:
INDICATIONS FOR USE:
Allux® is a dental silicate-glass ceramic that can be used by dental technicians to fabricate all-ceramic restorations by veneering aluminium oxide (Al2O3) frameworks.
The coefficient of thermal expansion [CTE (25 - 500°C)] of these aluminium oxide (Al₂O₃) frameworks had to equal approximately 8.0 x 10˚K¹ .
(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 (Optional Format 1-2-96)
Sures Radrin
Jusion Sign-Off) wision of Anesthesiology, General Hospital, ntection Control, Dental Devices
(k) Number: K050203
§ 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.