(38 days)
No
The description focuses on the material composition and intended use of a dental restorative system, with no mention of AI or ML.
No
The device is described as a restorative system for making crowns and bridges, which are used to restore the function or appearance of teeth. It is a dental material, not a therapeutic device designed to treat or prevent a disease or condition.
No
The device is a restorative system (porcelain for crowns and bridges), not a tool for diagnosing medical conditions.
No
The device description clearly states it is a "porcelain-fused-to-metal (PFM) restorative system," which are physical materials used in dental restorations, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is clearly described as a "porcelain-fused-to-metal (PFM) restorative system" for creating dental crowns, bridges, and veneers. This is a restorative dental material used in the mouth to repair or replace teeth.
- Device Description: The description reinforces that it's a dental porcelain system for layering on metal alloys or using with refractory/foil.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body as a dental restoration.
N/A
Intended Use / Indications 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.
Product codes
EIH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
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
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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