← Product Code [EIH](/productcode/EIH) · K012231 # AVANTE MICRO CRYSTAL SYSTEM (K012231) _Jeneric/Pentron, Inc. · EIH · Aug 23, 2001 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K012231 ## Device Facts - **Applicant:** Jeneric/Pentron, Inc. - **Product Code:** [EIH](/productcode/EIH.md) - **Decision Date:** Aug 23, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.6660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use Avante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations. ## Device Story Avante Micro Crystal System is a dental porcelain restorative material; designed for layering on conventional PFM alloys to create crowns and multiple-unit bridges; also used with refractory or foil for veneer restorations. System functions as a ceramic coating; requires firing by dental professionals in a laboratory setting. Lower firing temperature compared to predicate; chemical composition similar to existing market porcelains. Benefits include restorative functionality for dental patients requiring crowns, bridges, or veneers. ## Clinical Evidence No clinical data. Cytotoxicity testing was not performed due to the similarity in composition to other products currently on the market. ## Technological Characteristics Porcelain-fused-to-metal (PFM) restorative system. Material composition is chemically similar to existing dental porcelains. Designed for application on conventional PFM alloys, refractory, or foil. Requires specific firing temperatures for curing. ## Regulatory 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. ## Predicate Devices - Synspar Porcelain ([K910303](/device/K910303.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ #### 510(K) SUMMARY 21.0 Submitter: Jeneric/Pentron, Inc. 53 North Plains Industrial Road Address: Wallingford, Connecticut 06492 Contact Tel: 203-265-7397 X619 Contact Fax: 203-265-7662 Contact Person: Annmarie Tenero #### Date Summary Prepared: July 12, 2001 Avante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations. The composition of Avante Porcelain is similar to that of Synspar Porcelain, K910303. The The composition of Available of Avante was adjusted in Avante Porcelain to result in a lower firing temperature compared to Synspar. However, the actual list of chemical compounds present in Avante is similar to that of Synspar. The lower firing temperature of Avante compared to the predicate material has no affect on The lower ining temperatif the material. The properties of the material that make it safe and safecy and creet. Felless obtained if properly fired according to the user instructions provided with this product. Cytotoxcity testing was not performed due to the similarity of this device in composition to the other products currently on the market. 21.0 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be part of a larger document or sign. Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures. AUG 2 3 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Annmarie Tenero Jeneric/Pentron, Incorporated 53 No. Plaines Industrial Road Wallingford, Conecticut Re : K012231 Avante Micro Crystal System Trade/Device Name: 872.6660 Requlation Number: II Requlatory Class: Product Code: EIH Dated: July 12, 2001 Received: July 16, 2001 Dear Ms. Tenero: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: {2}------------------------------------------------ Page 2 - Ms. Tenero this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact 594-4639. Also, please note the Office of Compliance at (301) the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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, Timothy A. Ulatowski Timothy A. Ulat Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## 5.0 INDICATION FOR USE STATEMENT 510(k) NUMBER (IF KNOWN): _ K O / 乙 乙 乙 乙 乙 乙 乙 乙 乙 / # DEVICE NAME: AVANTE MICRO CRYSTAL SYSTEM ## INDICATION FOR USE: A vante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations. Mladha for MSR (Division Sign-Off) Division of Dental, Infection Control, and General Hospitat 510(k) Number ________________________________________________________________________________________________________________________________________________________________ (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 5.0 (Optional Format 1-2-96) Jeneric/Pentron, Inc. 510K Submission - AVANTE MICRO CRYSTAL SYSTEM --- **Source:** [https://fda.innolitics.com/device/K012231](https://fda.innolitics.com/device/K012231) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com