(242 days)
Not Found
No
The device is a material (zirconia blanks) used in the fabrication of dental restorations. While the fabrication process involves CAD/CAM technology, the description focuses on the material properties and its use in milling, not on any AI/ML algorithms for design or analysis. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is a material (milling blanks) used for fabricating custom dental restorations, not a therapeutic device itself. Its purpose is to create replacements for damaged or missing teeth, which is a restorative rather than purely therapeutic function in this context.
No
This device is described as "milling blanks for the fabrication of custom-made all-ceramic dental restoration," which are used to create dental prostheses. It is not used to diagnose a medical condition.
No
The device is a physical milling blank made of zirconia, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Nacera Pearl blanks are materials used to fabricate custom-made dental restorations (crowns, bridges, etc.). They are a component used by dental professionals to create a physical device that is placed in the patient's mouth, not used to test a sample from the patient's body.
- Intended Use: The intended use clearly states fabrication of dental restorations for anterior and posterior applications. This is a restorative function, not a diagnostic one.
- Device Description: The description details the material composition and how it's used in a CAD/CAM process to create dental prosthetics. There is no mention of analyzing biological samples.
Therefore, the Nacera Pearl blanks fall under the category of dental materials used for fabrication of medical devices (dental prosthetics), not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Nacera Pearl blanks are indicated for the fabrication of single crowns and bridgework:
-
fully anatomical single crowns and bridgework (FCZ)
-
Partially veneered or fully veneered crowns and bridges
-
Inlays, onlays, and Maryland bridges
-
Primary telescopic crowns
for anterior and posterior applications
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
The devices covered by this submission are milling blanks for the fabrication of custom-made all-ceramic dental restoration. The devices are manufactured from yttria-stabilized tetragonal zirconia (Y-TZP) complying with all applicable requirements of ISO 6872 (dental ceramics) and all requirements of ISO 13356 (ceramic materials for implants for surgery). They are provided in a partially sintered (pre-sintered) state. They are intended to be used by dental professionals e.g. dental technicians, for the fabrication of custom-made restorations for the sole use of a particular patient. These restorations are designed virtually by dental technicians using the CAD technology on the basis of intraoral scans or scans from impressions and/or models. The designed restorations are to be machined in all appropriate CAM Milling Centers out of Nacera Pearl blanks and finally sintered to full density. On basis of the available shades the finished restorations, sintered to full density, may be used as full-contour, all-ceramic prosthesis or may be veneered with suitable dental porcelains using the layering technique. Telescopic primary crowns will not be veneered. Nacera Pearl blanks are available in various shapes and dimensions such as discs, cylinders, bars, cubes, or other required forms, in order to meet the specifications of the different CAD/CAM milling machines used to generate the desired dental restorations. Nacera Pearl blanks are available in various shades in order to correspond to the different natural teeth colors and have a closer appearance to a natural tooth
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior applications
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals e.g. 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)
Performance Testing In order to demonstrate comparability of Nacera Pearl dental materials to the predicate devices a series of testing was performed according to ISO 13365 - in particular density, microstructure, flexural strength, and radio activity. Thermal expansion and chemical solubility was also performed according to ISO 13356. Open porosity, tensile strength, elastic limit, bending strength, Young's modulus comparative testing was also performed. The results of this testing showed that the physical properties and performance of the subject device are comparable to the identified predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K080195, K132102, K133213, K117210
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2015
Doceram Medical Ceramics GmbH Mr. Stefan Drude Head of Regulatory Affairs Hesslingsweg 65-67. Dortmund 44309 GERMANY
Re: K143071
Trade/Device Name: Nacera Pearl Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 7, 2015 Received: May 11, 2015
Dear Mr. Drude:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for DOCERAM Medical Ceramics. The logo is in a rectangular box with the word "DOCERAM" in bold, sans-serif font. There is a yellow triangle above the "O" in DOCERAM and a yellow line below the word. Below the box, the words "MEDICAL CERAMICS" are written in a smaller, sans-serif font.
Indications for Use
K143071 510(k) Number (if known):
Device Name: Nacera Pearl
Indications For Use:
Nacera Pearl blanks are indicated for the fabrication of single crowns and bridgework:
-
fully anatomical single crowns and bridgework (FCZ)
-
Partially veneered or fully veneered crowns and bridges
-
Inlays, onlays, and Maryland bridges
-
Primary telescopic crowns
for anterior and posterior applications
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steen -S 2015.06.25 12:39:57 -04'00'
DOCERAM Medical Ceramics GmbH
Fax:
Phone: +49 (0) 231 / 92 56 68 - 0 +49 (0) 231 / 92 56 68 - 60 info@doceram-medical.com www.doceram-medical.com
Hesslingsweg 65 - 67 D - 44309 Dortmund Germany
Commerzbank Dortmund BLZ 440 400 37 · KTO 28 27 020 BIC Code: COBADEFF440 IBAN: DE92440400370282702000
Qualitätsmanagementsystem Certified Company DIN EN ISO 13485 für Medizinprodukte
DCM.BP.02/2012 DMc
3
510[k] Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92
| Submitter Name | DOCERAM Medical Ceramics GmbH | ||
|---|---|---|---|
| Submitter Address | Hesslingsweg.65-67, D - 44309 Dortmund | ||
| Phone Number | +49-231-925025952 | ||
| Fax Number | +49-231-92566870 | ||
| Contact Person | Stefan Drude | ||
| Date summary was prepared | July 10, 2014 | ||
| Device Trade Name(s) | Nacera Pearl | ||
| Classification Name | Porcelain Powder for Clinical Use | ||
| C.D.R. section number | 872.6660 | ||
| Product Code | EIH | ||
| Regulatory Class | class II | ||
| Predicate Devices | K080195 | Nacera Z, Nacera Z Medium | |
| K132102 | BeCe CAD Zirkon HT+ | ||
| K133213 | StarCeram Z-Med | ||
| K117210 | ZENO Zr Disc | ||
| Device Description | The devices covered by this submission are milling blanks for | ||
| the fabrication of custom-made all-ceramic dental restoration | |||
| The devices are manufactured from yttria-stabilized tetragonal | |||
| zirconia (Y-TZP) complying with all applicable requirements of | |||
| ISO 6872 (dental ceramics) and all requirements of ISO 13356 | |||
| (ceramic materials for implants for surgery). | |||
| They are provided in a partially sintered (pre-sintered) state | |||
| They are intended to be used by dental professionals e.g. den- | |||
| tal technicians, for the fabrication of custom-made restorations | |||
| for the sole use of a particular patient. | |||
| These restorations are designed virtually by dental technicians | |||
| using the CAD technology on the basis of intraoral scans or | |||
| scans from impressions and/or models. | |||
| The designed restorations are to be machined in all appropriate | |||
| CAM Milling Centers out of Nacera Pearl blanks and finally sin- | |||
| tered to full density. |
4
| On basis of the available shades the finished restorations, sin-
tered to full density, may be used as full-contour, all-ceramic
prosthesis or may be veneered with suitable dental porcelains
using the layering technique. Telescopic primary crowns will not
| be veneered. |
|---|
| Nacera Pearl blanks are available in various shapes and di- |
| mensions such as discs, cylinders, bars, cubes, or other re- |
| quired forms, in order to meet the specifications of the different |
| CAD/CAM milling machines used to generate the desired dental |
| restorations,. |
| Nacera Pearl blanks are available in various shades in order to |
| correspond to the different natural teeth colors and have a clos- |
| er appearance to a natural tooth |
| Indications for Use |
| Nacera Pearl blanks are indicated for the fabrication of single |
| crowns and bridgework: |
| ➤ fully anatomical single crowns and bridgework (FCZ) |
| ➤ Partially veneered or fully veneered crowns and bridges |
| ➤ Inlays, onlays, and Maryland bridges |
| ➤ Primary telescopic crowns |
| for anterior and posterior applications |
Comparison of Indications for Use
| Device name | Intended Use |
|---|---|
| Doceram Medical | |
| Ceramics | |
| Nacera Pearl | Fabrication of all-ceramics custom-made restorations for the sole use of particular pa- |
| tients. It is recommended for: | |
| ➤ fully anatomical single crowns and bridgework (FCZ) | |
| ➤ Partially veneered or fully veneered crowns and bridges | |
| ➤ Inlay, onlays, and Maryland bridges | |
| ➤ Primary telescopic crowns | |
| ➤ for anterior and posterior segment restorations | |
| Doceram Medical Ce- | |
| ramics | |
| Nacera Z / Z Medium | 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. | |
| H.C. Starck | |
| StarCeram ® Z-Med | Fabrication of |
| ➤ crowns, | |
| ➤ multi-unit bridges, | |
| ➤ inlay bridges | |
| ➤ all- ceramic restorations. | |
| applications include both anterior and posterior bridges |
5
| BEGO
BeCe CAD Zirkon HT+ | Fabrication of all-ceramics custom-made restorations for the sole use of particular pa-
tients. It is recommended for:
fully anatomical single crowns and bridgework (FCZ)
Partially veneered or fully veneered crowns and bridges
Dentin core crowns and bridges | | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | > Maryland bridges | | |
| | > Telescopic crowns (primary part) | | |
| Wieland | Fabrication of all-ceramics restorations for the sole use of particular pa- | | |
| ZENO Zr | tients. It is recommended for: | | |
| | single-tooth and bridgework restorations like crowns and bridges with one or two pon-
tics, which can be used in the anterior as well as in the posterior tooth region. | | |
Comparison of Technological Characteristics
| Device name | Material Composition | Further Processing | Types | Physical Properties |
|---|---|---|---|---|
| DMC | ||||
| Nacera Pearl | Porcelain powder Y- | |||
| TZP | Milling in CAM milling | |||
| centers using | ||||
| CAD/CAM technique | pre-sintered blanks | ISO 13356 and ISO | ||
| 6872 | ||||
| DMC | ||||
| Nacera Z / Z Medium | Porcelain powder Y- | |||
| TZP | Milling in CAM milling | |||
| centers using | ||||
| CAD/CAM technique | pre-sintered milling | |||
| blank | ISO 13356 and ISO | |||
| 6872 | ||||
| H.C. Starck | ||||
| StarCeram ® Z-Med | Porcelain powder | Milling in CAM milling | ||
| centers using | ||||
| CAD/CAM technique | pre-sintered milling | |||
| blank | ISO 13356 and ISO | |||
| 6872 | ||||
| BEGO | ||||
| BeCe CAD Zirkon HT+ | Porcelain powder | Milling in CAM milling | ||
| centers using | ||||
| CAD/CAM technique | pre-sintered milling | |||
| blank | ISO 13356 and ISO | |||
| 6872 | ||||
| Wieland | ||||
| ZENO Zr | Porcelain powder | Milling in CAM milling | ||
| centers using | ||||
| CAD/CAM technique | partially (pre-) | |||
| sintered blank | ISO 13356 and | |||
| ISO 6872 |
The main differences between the subject device and the noted predicates are based on slight variations in shade (the end sintered dental restorations shade differences are caused by the chemical composition differing mass fractions of the ,oxide' components) as well as physical properties such as density and flexural strength.
Performance Testing In order to demonstrate comparability of Nacera Pearl dental materials to the predicate devices a series of testing was performed according to ISO 13365 - in particular density, microstructure, flexural strength, and radio activity. Thermal expansion and chemical solubility was also performed according to ISO 13356. Open porosity, tensile strength, elastic limit, bending strength, Young's modulus comparative testing was also performed.
6
Submitter: Doceram Medical Ceramics GmbH
The results of this testing showed that the physical properties and performance of the subject device are comparable to the identified predicates.
SE Conclusion: In conclusion, it has been shown that all devices are dental materials manufactured from the same porcelain powder Y-TZP, have comparable indications for use, technical, physical, chemical, and biological properties and characteristics, and have the same aesthetic and diagnostic function. Therefore, it can be demonstrated that Nacera Pearl dental materials are substantially equivalent to the predicate dental devices, Nacera Z, Nacera Z Medium, BeCe CAD Zirkon HT+, StarCeram Z-Med, and ZENO Zr.