(79 days)
Quattro Porcelain System is indicated for:
- PFM Applications: Single and multiple unit porcelain fused-to-metal fixed prosthodontic restorations.
- PTM Applications: Single and multiple unit porcelain pressed-to-metal fixed prosthodontic restorations.
- All-Ceramic Applications: Single unit anterior and posterior premolar metal-free fixed prosthodontic restorations, laminate veneers, inlays and onlays.
The Quattro Porcelain System is an integrated porcelain system used for the fabrication of dental restorations using three major porcelain fabrication techniques: porcelain-fused-to-metal (PFM), pressed-to-metal (PTM), and pressed all-ceramic (AC). Quattro PFM and PTM are indicated for both anterior and posterior crowns and bridges. Quattro AC is indicated for anterior to pre-molar crowns, inlays and onlays, and veneers.
The provided text describes the "Quattro Porcelain System" and its substantial equivalence to a predicate device for dental restorations. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/algorithm-based medical device.
The document is a 510(k) summary for a dental porcelain system, which is a physical material, not an AI or algorithm-based device. Therefore, the types of questions posed in your request (sample sizes for test sets, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, AI assistance effect size, etc.) are not applicable to this document.
The document discusses:
- Device Name: Quattro Porcelain System
- Indications for Use: PFM, PTM, and All-Ceramic applications for various dental restorations.
- Predicate Device: DENTSPLY International Finesses Low Fusing Porcelain System (K954761)
- Technological Characteristics: Integrated system using components from legally marketed devices, with biocompatibility testing performed.
- Non-Clinical Performance Data: Stated that the performance of the structural components (dentin and ingot porcelain) are "comparable to other legally marketed Ceramco porcelains commercially used and successful for PFM and PTM restorations." This is a general statement of comparability and not a detailed study with specific acceptance criteria and results.
- Conclusion of Substantial Equivalence: Based on prior use of components, performance data (described as "comparable"), and biocompatibility data.
Therefore, I cannot fulfill your request using the provided text because it does not contain the information relevant to AI/algorithm performance studies. The document is for a traditional medical device (dental material) and its 510(k) clearance process.
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Image /page/0/Picture/24 description: The image shows the word "DENTSPLY" in all capital letters. The font is bold and sans-serif. The letters are tightly spaced together. The image is in black and white.
DENTSPLY International
World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 (800) 877-0020 Fax (717) 849-4343 www.dentsply.com
AUG 2 8 2009
510(k) SUMMARY for Quattro Porcelain System
- Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |
June 8, 2009 Date Prepared:
2. Device Name:
Proprietary Name: ◆
- Classification Name: .
- CFR Number: ●
- Device Class: .
- Product Code: EIH .
Predicate Device: 3.
- DENTSPLY International Company: ● Finesses Low Fusing Porcelain System Device: ●
- K954761 510(K) No.: .
- Date Cleared: 11/02/1995 .
Description of Device: 4.
The Quattro Porcelain System is an integrated porcelain system used for the fabrication of dental restorations using three major porcelain fabrication techniques: porcelain-fused-to-metal (PFM), pressed-to-metal (PTM), and pressed all-ceramic (AC). Quattro PFM and PTM are indicated for both anterior and posterior crowns and bridges. Quattro AC is indicated for anterior to pre-molar crowns, inlays and onlays, and veneers.
Quattro Porcelain System
Powder, Porcelain
872.6660
II
000009
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Indications for Use: 5.
Quattro Porcelain System is indicated for:
-
- PFM Applications: Single and multiple unit porcelain fused-to-metal fixed prosthodontic restorations.
-
- PTM Applications: Single and multiple unit porcelain pressed-to-metal fixed prosthodontic restorations.
-
- All-Ceramic Applications: Single unit anterior and posterior premolar metal-free fixed prosthodontic restorations, laminate veneers, inlays and onlays.
Description of Safety and Substantial Equivalence: 6.
Technological Characteristics
The Quattro Porcelain System is an integrated system that can be used for porcelain fused to metal (PFM), pressed to metal (PTM), and all-ceramic (AC) restorations. All of the components found in the Quattro Porcelain System have been used in legally marketed devices and/or were found safe for dental use. The Ouattro veneering has been evaluated and passed biocompatibility testing for cvtotoxicity, irritation, systemic toxicity, sensitization, oral irritation, and genotoxicity.
Non-Clinical Performance Data
The performance of the Quattro Porcelain System's two structural components, dentin and ingot porcelain are comparable to other legally marketed Ceramco porcelains commercially used and successful for PFM and PTM restorations.
Conclusion as to Substantial Equivalence
We believe that the prior use of the components of the Quattro Porcelain System in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the Quattro Porcelain System for the indicated uses.
We believe that the test data and the predicate comparisons provided in the Quattro Porcelain System 510(k) application demonstrate that the device is as safe and as effective as the predicate device.
000010
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 8 2009
Ms. Helen Lewis
Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404-0872
Re: K091706
Trade/Device Name: Quattro Porcelain System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: June 8, 2009 Received: June 10, 2009
Dear Ms. Lewis:
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 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 - Ms. Lewis
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runner
Susan Runner, D.D.S., M.A. Acting 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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INDICATIONS FOR USE STATEMENT
109 706
510(k) Number (if known):
Device Name: Quattro Porcelain System
Indications for Use:
Quattro Porcelain System is indicated for:
-
- PFM Applications: Single and multiple unit porcelain fused-to-metal fixed prosthodontic restorations.
-
- PTM Applications: Single and multiple unit porcelain pressed-to-metal fixed prosthodontic restorations.
-
- All-Ceramic Applications: Single unit anterior and posterior premolar metal-free fixed prosthodontic restorations, laminate veneers, inlays and onlays.
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)
Reim Marley for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K091706Quattro Porcelain System
000008
§ 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.