ALLUX

{0}------------------------------------------------ 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." K050203 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® K944702 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: {1}------------------------------------------------ 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;<br>White, Yellow, Violet, Orange, Brown, Gum | | Dentine | A1; A2; A3; A3,5; A4; B1; B2; B3; B4; C1; C2; C3; C4; D2; D3; D4;<br>Crystal 1 light; Crystal 2 pearl; Crystal 3 creme; Gum 1; Gum 2; Gum 3;<br>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;<br>Topas; Anthrazit; Amethist; Aquamarin; Citrin; Rubin; Lemon; Melon;<br>Transpa Neutral; Transpa Clear | | Opale incisal | Opale Incisal 1, Opale Incisal 2, Opale Incisal 3, Opale Incisal 4,<br>Crystal Blue, Frosty, Milky, Snow, Ice | | Shoulder porcelains margin | High Flu, High 1, High 2, High 3, High 4, High Red, High Crystal;<br>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;<br>Violet; Gum; Marone; Olive; Ivory; Yellow;<br>Bodystain A; Bodystain B; Bodystain C; Bodystain D | | Glaze | Glaze | | Correction | Correction | {2}------------------------------------------------ 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. {3}------------------------------------------------ ## 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 {4}------------------------------------------------ | Page | 1 | of | | |------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|--| | l | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | | K050203 | |---------| |---------| 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