(75 days)
Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Aidite Zirconia Dental Ceramics are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by iso-static pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices.
The provided document is a 510(k) summary for Aidite Zirconia Dental Ceramics. It explicitly states that "Clinical testing was not performed for Aidite Zirconia Dental Ceramics as part of the Pre-market Notification requirements for this submission, as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US."
Therefore, the device's acceptance criteria are demonstrated through physical, chemical, and biocompatibility testing against established international standards and by demonstrating substantial equivalence to a predicate device, rather than through a clinical study with human subjects.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the physical and mechanical properties of dental ceramics and the requirements of the predicate device, as well as the ISO standards mentioned. The document provides the device's reported physical and mechanical properties.
| Characteristic | Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (Aidite Zirconia Dental Ceramics) |
|---|---|---|
| ZrO₂ | < 96 % wt (consistent with dental zirconia) | < 96 % wt |
| Y₂O₃ | > 4% (consistent with dental zirconia) | > 4% |
| HfO₂ | > 1% (consistent with dental zirconia) | > 1% |
| Al₂O₃ | < 1% (consistent with dental zirconia) | < 1% |
| SiO₂ | < 0.02% (consistent with dental zirconia) | < 0.02% |
| Crystal Morphology | Tetragonal | Tetragonal |
| Color | White | White |
| Density (pre sintering) | Consistent with dental zirconia | 3.10 g/cm³ |
| Density (post sintering) | Consistent with dental zirconia | 6.05 g/cm³ |
| Fracture Toughness (pre sintering) | Consistent with dental zirconia | 55 Mpa |
| Fracture Toughness (post sintering) | Consistent with dental zirconia | 1200 Mpa |
| Elastic modulus (post sintering) | Consistent with dental zirconia | 210 Gpa |
| Sintering temperature | Consistent with dental zirconia | 1480°C |
| Shrinkage (pre sintering) | Consistent with dental zirconia | 20.00% |
| Shrinkage (post sintering) | Consistent with dental zirconia | 22.00% |
| Porosity | 0% (ideal for densified ceramics) | 0% |
| Biocompatibility | Compliant with ISO 10993-1 | Compliant with ISO 10993-1 |
| Physical & Chemical Properties | Compliant with ISO 6872 and BS EN 1641 | Compliant with ISO 6872 and BS EN 1641 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as no clinical test set was used. The testing referenced falls under material characterization. The document states: "Aidite Zirconia Dental Ceramics have been tested for their physical and chemical properties in accordance with ISO 6872 and BS EN 1641, as well as biocompatibility in accordance with ISO 10993-1." The testing would have been done retrospectively on samples of the manufactured material. The country of origin for the manufacturing of the device is China. The raw materials are sourced from Japan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set or ground truth established by experts was used. The ground truth for material properties is established by recognized international standards (ISO, BS EN).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this device is a dental material, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is compliance with established international standards for physical, chemical, and biocompatibility properties of dental ceramics. This is determined through standardized laboratory testing, rather than expert consensus on clinical cases, pathology, or outcomes data, as no clinical study was performed.
8. The sample size for the training set
Not applicable, as no algorithm or training set was involved.
9. How the ground truth for the training set was established
Not applicable, as no algorithm or training set was involved.
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Image /page/0/Picture/0 description: The image shows the logo for Emergo Group. The logo consists of the word "EMERGO" followed by a stylized letter "E" inside of a circle. The word "GROUP" is to the right of the circle. The text is in a sans-serif font.
Zirconia Dental Ceramics
KII1291
JUL 200 2011
SECTION 5 - 510(k) SUMMARY
Submission Correspondent
Company Name: Company Address:
Company Contact:
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| Submission Date: | |
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Submission Sponsor
Company Name: Company Address:
Country: Phone: Fax: Website:
Device Classification
Device Sponsor:
Device Trade Name:
Product Classification Name:
Product Code:
Regulation Name:
Regulation Number:
Classification Panel:
Emergo Group, Inc. 611 West 5th Street Third Floor Austin, TX 78701 Stuart R. Goldman Senior Consultant 512.600.7616 USA 512.327.9997 512.327.9998 April 22, 2011 www.emergogroup.com/
Qinhuangdao Aidite High-Technical Ceramics Co. 12 North of West Ring Road - Economic and Technological Development Zone Qinhuangdao City China 0086-335-8587898 0086-335-8587198 www.zro2blocks.com/
Qinhuangdao Aidite High-Technical Ceramics Co.
Aidite Zirconia Dental Ceramics
Powder, Porcelain
ElH
Porcelain powder for clinical use
872.6660
Dental Devices
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EMERGO GROUP
Image /page/1/Picture/1 description: The image shows a world map in the background with the Aidite logo in the foreground. The Aidite logo is a black square with a white "A" in the center. The word "Aidite" is written in black letters below the square. To the right of the logo, the word "Zirconia" is written in black letters. The map appears to be a simplified representation of the continents.
Zirconia Dental Ceramics
Intended Use
Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Predicate Device
Upcera Zirconia Blanks (K093560)
Device Description
Aidite Zirconia Dental Ceramics are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by iso-static pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices. Physical and mechanical properties for Aidite Zirconia Dental Ceramics are shown in Table 5-1 and are similar in nature to the predicate device.
| Table 5-1Physical & Mechanical PropertiesAidite Zirconia Dental Ceramics | |
|---|---|
| ZrO₂ | < 96 % wt |
| Y₂O₃ | > 4% |
| HfO₂ | > 1% |
| Al₂O₃ | < 1% |
| SiO₂ | < 0.02% |
| Crystal Morphology | Tetragonal |
| Color | White |
| Density (pre sintering) | 3.10 g/cm³ |
| Density (post sintering) | 6.05 g/cm³ |
| Fracture Toughness (pre sintering) | 55 Mpa |
| Fracture Toughness (post sintering) | 1200 Mpa |
| Elastic modulus (post sintering) | 210 Gpa |
| Sintering temperature | 1480°C |
| Shrinkage (pre sintering) | 20.00% |
| Shrinkage (post sintering) | 22.00% |
| Porosity | 0% |
Aidite Zirconia Dental Ceramics are offered in seven (7) different product families of shapes and a multitude of different sizes as shown below in Figure 1 and Table 5-2 and are capable of being machined into complex dental shapes using modern machining methods, and are similar to the sizes and shapes of the predicate device. The one exception is the AS-XND System of
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EMERGO GGROUP
Image /page/2/Picture/1 description: The image shows a logo with the text "Zirconia Dental Ceramics". To the left of the text is a logo that includes a stylized letter "A" and the word "Aidite" below it. Above the logo is a faint outline of a world map. The logo and text appear to be for a dental ceramics company.
blocks is pre-mounted on mandrels. Any difference in the net shapes and dimensions between Aidite Zirconia Dental Ceramics and those offered by the manufacturer of the predicate devices are incidental to the performance of the final dental prosthetic devices that will be fabricated from them.
Figure 1 Aidite Zirconia Dental Ceramics
Image /page/2/Picture/4 description: The image shows a collection of various shapes and sizes of objects arranged in a circular pattern. There are circular, rectangular, and other irregularly shaped objects. The objects appear to be made of a light-colored material, possibly ceramic or plastic. The background is a dark, textured surface, which contrasts with the lighter objects.
| Table 5-2Aidite Zirconia Dental Ceramics Product Family | |
|---|---|
| Family | Shapes & Sizes Available |
| AC System | Blocks: 20 x 26.5 x 25 to 25 x 72 x 40 (mm) |
| AF System | Blocks: 29 x 58 x 16 to 40 x 85 x 22 (mm) |
| Discs: 95 x 10 to 100 x 25 (mm) | |
| AG System | Blocks: 20 x 40 x 16 to 20 x 65 x 30 (mm) |
| Discs: 98 x 12 to 98 x 20 (mm) | |
| Spheres: 90 x 12 x 71 to 90 x 25 x 71 (mm) | |
| AK-KAVA System | Blocks: 20 x 42 x 16 to 16 x 60 x 20 (mm) |
| Rods: 16 x 16 to 20 x 20 (mm) | |
| AS-XND System | Blocks: 14 x 20 x 15 to 20 x 65 x 25 (mm)(with mandrel) |
| AW-WLD System | Discs: 98 x 10 to 98 x 25 (mm) |
| AZ-KFS System | Blocks: 25 x 43 x 16 to 36 x 75 x 16 (mm) |
| Rods: 23 x 16 (mm) | |
| Spheres: 87 x 16 x 56 to 93 x 16 x 75 (mm) |
Product Performance Testing
Aidite Zirconia Dental Ceramics have been tested for their physical and chemical properties in
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EMERGO GROUP
Image /page/3/Picture/1 description: The image shows a world map in the background with the logo of "Aidite" in the foreground. The logo consists of a stylized letter "A" with a curved line above it. The word "Aidite" is written in bold letters below the symbol. To the right of the logo, the word "Zirconi" is partially visible.
Zirconia Dental Ceramics
accordance with ISO 6872 and BS EN 1641, as well as biocompatibility in accordance with ISO 10993-1.
Clinical Testing
Clinical testing was not performed for Aidite Zirconia Dental Ceramics as part of the Pre-market Notification requirements for this submission, as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US. The raw materials used in Aidite Zirconia Dental Ceramics are identical to the raw material used in the predicate device and are sourced from the same raw material supplier in Japan, and do not raise any questions regarding their safety and effectiveness as compared to the predicate device.
Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the differences between Aidite Zirconia Dental Ceramics and the predicate device do not raise any questions regarding its safety and effectiveness. Aidite Zirconia Dental Ceramics, as designed and manufactured, therefore are determined to be substantially equivalent to Upcera Zirconia Blanks previously cleared under K093560.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Qinhuagdao Aidite High-Technical Ceramics Company, Limited C/O Mr. Stuart R. Goldman Emergo Group, Incorporated 611 5th Street, Third Floor Austin, Texas 78701
Re: K111291
Trade/Device Name: Aidite Zirconia Dental Ceramics Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH and ELL Dated: April 22, 2011 Received: May 6, 2011
JUL 20 2011
Dear Mr. Goldman:
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.
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Page 2 - Mr. Goldman
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Anthony D. Watson, B.S., M.S., M.B.A.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| EMER | |
|---|---|
| idite | Zirconia Dental Ceramics |
《》 29
GO GROUP
SECTION 4 - INDICATIONS FOR USE
510(k) Number (if known):
Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Prescription Use X
and/or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Sura Ruase
Division Sign-Off) Division of Anesthesiology, General Hospltal nfection Control, Dental Devices
:10(k) Number: K111221
§ 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.