(94 days)
The device is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM or hot-press methods.
The device is comprised of dental porcelain powder in the nature of a lithium silicate glass ceramic that is used in the form of ceramic blanks. The device has excellent casting and machining properties and can be used to obtain highly esthetic dental restorations with desirable characteristics including improved density and flexural strength compared to predicate devices.
The provided text describes Obsidian™ Ceramic Blocks, a dental porcelain powder used to fabricate ceramic dental prostheses. The document outlines the device's technical specifications, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them, presented in the requested format:
Acceptance Criteria and Device Performance Study for Obsidian™ Ceramic Blocks
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Demonstrated by substantial equivalence to predicate devices (e.max CAD-K051705 and IPS Empress 2 - K982616) and lack of new safety concerns due to minor material differences. |
| Effectiveness | Demonstrated by substantial equivalence to predicate devices and positive clinical outcomes in a small investigational study. Adherence to physical properties as determined in nonclinical testing. |
| Functionality | Predicted to function similarly to other comparative devices. |
| Biocompatibility | Implicitly accepted through substantial equivalence to legally marketed dental ceramic materials. |
| Physical Properties (Strength & Density) | Increased final density and higher values of flexural strength compared to predicate lithium disilicate glasses. |
| Esthetics | "Excellent esthetics" observed in clinical cases. |
| Durability/Performance over time | All 28 restorations in the clinical study performing as expected with no replacements required. (9 restorations 6-9 months in place, 23 restorations >3 months in place). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data): 28 custom-made restorations (27 crowns and 1 inlay) for 16 patients.
- Data Provenance: Retrospective clinical observation of restorations placed from October 2, 2009, through May 4, 2010. The geographical origin of the patients/clinic is not specified, but it can be inferred to be within the US given the context of a 510(k) submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth in the clinical evaluation. It mentions "All of the restorations were placed...demonstrating excellent esthetics...All 28 restorations are performing as expected based on the physical properties...with no replacements required." This suggests that the assessment of performance and esthetics was likely made by the treating dentists or possibly an internal team at Prismatik Dentalcraft, Inc., based on their clinical judgment. There is no mention of external, independent expert review to establish a formal ground truth.
4. Adjudication Method for the Test Set
No formal adjudication method (e.g., 2+1, 3+1) is described for the clinical data. The assessment appears to be a direct observation of clinical outcomes by the practitioners involved or the device manufacturer, rather than an adjudicated review.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The clinical data provided is an observational study of restorations made with the subject device, without direct comparison against human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical dental material (ceramic blocks) for fabricating prostheses, not an AI or software algorithm. Therefore, there is no "standalone algorithm performance" to evaluate.
7. The Type of Ground Truth Used
The ground truth for the clinical data was based on:
- Clinical Outcomes/Performance: Direct observation of the restorations' structural integrity and functionality in the oral cavity, including the absence of failures or replacements.
- Clinical Esthetics: Subjective assessment of the esthetic appearance of the restorations, described as "excellent esthetics."
- Correlation with Physical Properties: The clinical performance was deemed to be "as expected based on the physical properties of the subject device as determined in the nonclinical testing."
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical material, not an AI or machine learning model that requires a "training set." The development of the ceramic material would involve material science research and engineering, not data training in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8. The "ground truth" for the material's development would be established through material science principles, laboratory testing (e.g., flexural strength, density measurements), and chemical analysis, rather than a "training set" with established ground truth labels as typically seen in AI development.
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510(k) Summary (K100781)
Submitter:
JUN 2 1 2010
Prismatik Dentalcraft, Inc. 4141 MacArthur Blvd. Newport Beach, CA 92660
Contact Person(s):
Keith D. Allred, 949-440-2683 (p) / 949-440-2787 (f) and consultants, Robin Carden & Wolfgang Freibauer
Date of Application: March 15, 2010
ldentification of the Device: Obsidian™ Ceramic Blocks, product code "EIH," non-exempt Class II (CFR §872.6660 - Porcelain powder for clinical use)
Substantial Equivalence: The device is substantially equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: (1) IPS e.max CAD/IPS e.max ZirCAD (Ivoclar, K051705); and (2), IPS Empress 2 (Ivoclar, K982616).
Description of the Device: The device is comprised of dental porcelain powder in the nature of a lithium silicate glass ceramic that is used in the form of ceramic blanks. The device has excellent casting and machining properties and can be used to obtain highly esthetic dental restorations with desirable characteristics including improved density and flexural strength compared to predicate devices.
Indications for Use: The device is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM or hot-press methods.
Safety and Efficacy: Studies comparing the subject device to predicate devices (e.max CAD-K051705 and IPS Empress 2 - K982616) demonstrate that the subject device is safe and effective for use fabricating restoratives in the nature of ceramic crowns, bridges, veneers, inlays and onlays using CAD/CAM and press-ceramic methods. Both the subject and predicate devices are lithium silicon glass ceramics and substantially identical in that they use the same basic components. The predicate devices contain lanthanum oxide whereas the subject device uses germanium dioxide, resulting in a lithium silicate glass ceramic with increased final density and higher values of flexural strength compared to lithium disilicate glasses.
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Additionally, clinical data was provided for investigational purposes. CAD/CAM methods were used to mill twenty-eight custom made restorations using the subject device, comprising 27 crowns and 1 inlay for 16 patients. All of the restorations were placed from October 2, 2009 through May 4, 2010 demonstrating excellent esthetics (9 of the restorations have been in place from 6 to 9 months and 23 restorations have been in place for more than 3 months). All 28 restorations are performing as expected based on the physical properties of the subject device as determined in the nonclinical testing with no replacements required.
Conclusions drawn from the nonclinical and clinical data demonstrate that the subject device functions in a similar manner to other comparative devices and the intended use is the same. The fundamental scientific technology of the subject device has not changed relative to the predicate devices and the differences between the subject and predicate devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the subject device are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification and are assured through wide, general use of similar other predicate devices that demonstrate the safe use of the subject device to construct dental restorations.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 1 2010
Mr. Keith Allred Prismatik Dentalcraft, Incorporated 4141 MacArthur Boulevard Newport Beach, CA 92660
Re: K100781
Trade/Device Name: Obsidian" Ceramic Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: May 19, 2010 Received: May 24, 2010
Dear Mr. Allred:
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. Allred
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/Offices/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Susan Penner
WAnthony 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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Schedule B
Indications for Use Statement
- 510(k) Number (if known): K100781 ♪
- Device Name: Obsidian™ Ceramic Blocks ▼
- Indications for Use: ♪
The device is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM or hot-press methods.
Prescription Use X (Part 21 CFR 801 SubpartD) AND/OR
Over-The-Counter Use (21 CFR 801 SubpartC)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Maduy for MSR
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K100781
§ 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.