(94 days)
Not Found
No
The device is a ceramic material for dental restorations and its description focuses on its material properties and manufacturing process using CAD/CAM techniques, with no mention of AI or ML.
No.
The device is a ceramic material used by dental technicians to manufacture all-ceramic restorations (substructures/frameworks) for dental crowns and bridges, not a therapeutic device itself.
No
Explanation: The device is a dental ceramic material used to manufacture all-ceramic restorations and frameworks. It is a material for creating dental prosthetics, not for diagnosing medical conditions.
No
The device is a physical ceramic material (zirconia) used for manufacturing dental restorations, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manufacture dental restorations (frameworks for crowns and bridges) for individual patients. This is a structural component used in the body, not a test performed on a sample from the body to diagnose a condition.
- Device Description: The description details a ceramic material used for creating physical dental prosthetics. It focuses on material properties, manufacturing processes (CAD/CAM, sintering), and biocompatibility for implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used to create a physical restoration that is placed in vivo (inside the body).
N/A
Intended Use / Indications for Use
Nacera Z and Nacera Z Medium are a dental ceramic designed to be used by dental technicians to manufacture all-ceramic restorations. Nacera Z and Nacera Z medium are Yttria (Yttrium Oxide) stabilized tetragonal zirconia (Zirconia oxide) powder delivered in a partially sintered state.
Nacera Z and Nacera Z Medium is specially designed for use as framework (substructure) for dental restorations, single tooth or bridge type application at anterior and posterior locations.
It is prepared for machining by use of CAM-techniques.
The machined frameworks like dental crown and bridge works are sintered to full density.
Product codes
EIH
Device Description
Nacera Z is a ceramic material for dental restorations.
Nacera Z is composed of partially sintered yttrium oxide stabilized zirconium oxide.
Nacera Z is designed for manufacturing all-ceramic dental restorations (substructures) for the sole use of particular patients. It is machined on milling centers by use of CAD/CAM techniques for design and processing.
Nacera Z is designed for dental restorations like single tooth crowns or bridgeworks. It is biocompatible, biostable, and insoluble in water.
Due to the outstanding high strength of densely sintered ceramic restorations Nacera Z enables dental technicians to design finely shaped, precise, and filigree framework.
Nacera Z is delivered as presintered white blanks, which change during final sintering and effected by minimal alterations of oxide composition to characteristic hues from white to light pearl. That offers an outstanding basis for aesthetical restorations.
All above mentioned advantages ensure safe, resistant, and effective dental restorations.
Nacera Z substructures are well suited to be veneered with suitable dental porcelains using the layering technique.
Nacera Z meets all applicable requirements of International standard ISO 6872:1999 "Dental ceramic". It meets even the the international standard 13356:1997 "Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirkonia" for biocompatible and biostable dental implants and restorations.
The partially sintered Nacera Z blanks are fabricated in two different types, distincted by their presintered density and hue, each type available as disks with different dimensions depending upon custormer's request.
Nacera Z is delivered in various shapes and dimensions in order to meet individual customer requirements. Possible shapes are: disk, cylinder, cube.
Nacera Z is available in two different types. Nacera Z and Nacera Z Medium. The differ in hue effected by slightly changed ratios of the oxides in order to meet individual customer's requirements. Both types are available in both presintered densities 3,09 g/cm³ and 3,20 g/cm³
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior locations
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
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
Kogdq5
Premarket Notification 510(k)
Nacera Z
Section VI
APR 2 8 2008
510 (K) Summary
| Submitter of 510 (k): | DOCERAM Medical Ceramics GmbH
Hesslingsweg 65-67
44309 Dortmund
Phone: +49-231-925668-0
Telefax +49-231-925668-60
e-mail info@doceram-medical.com
Web: www.doceram-medical.com |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Holger Wampers
General Manager
Phone: +49-231-925668-63
Telefax +49-231-925668-60
e-mail h.wampers@doceram-medical.com |
| Date of Summary | November 06, 2007 |
| Trade Name | Nacera Z
Nacera Z Medium |
| Classification name: | Porcelain Powder for clinical use |
| Product code | EIH |
| C.O.R. section | 872.6660 |
| Classification | Class II |
| Legally marketed equvalent device | Zerion beta |
| 510 (k) number | K061804 |
| Device Description | Nacera Z is a ceramic material for dental restorations.
Nacera Z is composed of partially sintered yttrium oxide stabi-
lized zirconium oxide.
Nacera Z is designed for manufacturing all-ceramic dental res-
torations (substructures) for the sole use of particular patients.
It is machined on milling centers by use of CAD/CAM tech-
niques for design and processing. |
:
1
Nacera Z is designed for dental restorations like single tooth crowns or bridgeworks. It is biocompatible, biostable, and insoluble in water.
Due to the outstanding high strength of densely sintered ceramic restorations Nacera Z enables dental technicians to design finely shaped, precise, and filigree framework.
Nacera Z is delivered as presintered white blanks, which change during final sintering and effected by minimal alterations of oxide composition to characteristic hues from white to light pearl. That offers an outstanding basis for aesthetical restorations.
All above mentioned advantages ensure safe, resistant, and effective dental restorations.
Nacera Z substructures are well suited to be veneered with suitable dental porcelains using the layering technique.
Nacera Z meets all applicable requirements of International standard ISO 6872:1999 "Dental ceramic". It meets even the the international standard 13356:1997 "Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirkonia" for biocompatible and biostable dental implants and restorations.
The partially sintered Nacera Z blanks are fabricated in two different types, distincted by their presintered density and hue, each type available as disks with different dimensions depending upon custormer's request.
Nacera Z is delivered in various shapes and dimensions in order to meet individual customer requirements. Possible shapes are: disk, cylinder, cube.
Nacera Z is available in two different types. Nacera Z and Nacera Z Medium. The differ in hue effected by slightly changed ratios of the oxides in order to meet individual customer's requirements. Both types are available in both presintered densities 3,09 g/cm³ and 3,20 g/cm³
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2008
Mr. Holger Wampers Managing Director DOCERAM Medical Ceramics GmbH Hesslingsweg 65-67 D-44309 Dortmund GERMANY
Re: K080195
Trade/Device Name: Nacera Z, Nacera Z Medium Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 2, 2008 Received: February 19, 2008
Dear Mr. Wampers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2- Mr. Wampers
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination it as your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Fedurements. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); $1, CFR 1000, 1050 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Sustite Y. Mchan Duid
Olivia Liao, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION IV
Indications for Use
17680195 510(k) Number (if known):
Device Name: Nacera Z, Nacera Z Medium
Indications for Use:
Nacera Z and Nacera Z Medium are a dental ceramic designed to be used by dental technicians to manufacture all-ceramic restorations. Nacera Z and Nacera Z medium are Yttria (Yttrium Oxide) stabilized tetragonal zirconia (Zirconia oxide) powder delivered in a partially sintered state.
Nacera Z and Nacera Z Medium is specially designed for use as framework (substructure) for dental restorations, single tooth or bridge type application at anterior and posterior locations.
It is prepared for machining by use of CAM-techniques.
The machined frameworks like dental crown and bridge works are sintered to full density.
Prescription Use Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
DRH_ Office of Device_Evaluation (ODE) Concurrence of C
Karin Malsky for MSK
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080195
section IV