(108 days)
Not Found
No
The summary describes a dental composite material and its physical properties, with no mention of AI/ML or image processing.
No.
The device is a dental restorative material used to fill cavities, which is a structural repair rather than a therapeutic treatment.
No
Prestige is described as a "dental composite restorative material" and a "light-cured, Nanohybrid dental restorative material intended for use for the restoration in all classes of cavities." This indicates it is a therapeutic material used for repair, not for diagnosing conditions.
No
The device is a dental composite restorative material, which is a physical substance, not software. The description and performance studies focus on material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a dental composite restorative material designed to be used in all classes of cavities." This describes a material used in the mouth for restoring teeth, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description reinforces this, stating it's a "light-cured, Nanohybrid dental restorative material intended for use for the restoration in all classes of cavities."
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a disease or condition
The information clearly indicates that Prestige is a dental material used for direct restoration of teeth, which is a clinical procedure performed on a patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Prestige is a dental composite restorative matieral designed to be used in all classes of cavities
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Prestige(TM) is a light-cured, Nanohybrid dental restorative material intended for use for the restoration in all classes of cavities
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Testing performed on Prestige(TM) included the followings:
- Flexural Strength
- · Depth of Cure
- Sensitivity to Ambient Light
- Diametral Strength
- Water Sorption
- Shade and Color Stability
- Radiopacity
The substantial equivalence or suitability to the intended purpose of Prestige(TM) has been demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices currently on the market. Results of our bench testing indicate that Prestige(TM) has the same performance and technological characteristics.
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.
K943642 Herculite XR & XRV By Sybron Dental Specialties, Inc
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(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 stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21,2015
Danville Materials LLC Dong Hua Regulatory Affair Director 3420 Fostoria Way Suite A-200 San Ramon, California 94583
Re: K151514
Trade/Device Name: Prestige Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 18, 2015 Received: June 23, 2015
Dear Dong Hua:
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.
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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,
Susan Runno DDS, MA
Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Prestige
Indications for Use (Describe)
Prestige is a dental composite restorative matieral designed to be used in all classes of cavities
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed annound the and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is a logo for Danville Engineering & Materials. The logo features a blue square with a stylized image of a light source emitting rays. To the right of the square is the company name, "Danville," in a bold, sans-serif font, with the words "ENGINEERING & MATERIALS" in a smaller font underneath.
3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA
007_ 510(K) Summary
This summary of the Traditional 510(K) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92
Applicant's Name and Address A.
- A Name: Danville Materials LLC
- A Address: 3420 Fostoria Way Suite A-200 San Roman, CA 94583 USA
- A Contact Person: Dong Hua
- A Title: Regulatory Affair Director and QA Manager
-
800-827-7940/925-973-0710. Ext. 212 Phone:
-
Fax: 925-973-0764
- A Date Summary Prepared: May 26, 2015
B. The Name of the Device:
- Trade/Proprietary Name: Prestige™ A
- The common name of the device: Tooth Shade Resin Material A
- A The Classification Name: Material, Tooth Shade, Resin per 21 CFR 872.3690
- A Product Code EBF has been classified as a Class II device
C. Legally Marketed Predicate Device to Which Substantial Equivalence (SE) is claimed:
- K943642 Herculite XR & XRV By Sybron Dental Specialties, Inc A
D. Description of the Device:
- Indication For Use: Indication For Use: Prestige™ is a dental composite restorative A material designed to be used in all classes of cavities
- Intended Use of the Device: Prestige™ is a light-cured, Nanohybrid dental A restorative material intended for use for the restoration in all classes of cavities
E. A comparison between the Herculite XR & XRV by Sybron Dental Specialties, Inc and Prestige™ by Danville Materials to determine SE:
-
The equivalence to the predicate device is supported by the Physical and Mechanical Properties performance testing
-
Chemicals, function of each component of the product are identified
-
Similarities in the Indications for Use:
4
Image /page/4/Picture/0 description: The image contains the logo for Danville Engineering & Materials. The logo features a blue square with a stylized design inside, resembling a light source with rays emanating from it. To the right of the square is the company name "Danville" in a bold, sans-serif font, with the words "ENGINEERING & MATERIALS" in a smaller font size underneath.
www.danvillematerials.com
3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA
| Product | 510(K) Number | Classification Name | Indications For Use |
|---|---|---|---|
| Herculite XR & XRV By Sybron Dental Specialties, Inc | K943642 | Tooth Shade Resin Material | dental composite restorative material designed to be used in all classes of cavities |
| PrestigeTM | New | Tooth Shade Resin Material | PrestigeTM is a dental composite restorative material designed to be used in all classes of cavities |
- A Discussion of Non-Clinical and Clinical tests performed for determination of Substantial Equivalence:
Prestige™ is a resin based material that is light cured, the same as used by our predicates, Herculite XR & XRV By Sybron Dental Specialties, Inc (K943642). These materials have been widely used by numerous manufacturers in the medical/dental industry.
Non-Clinical Testing performed on Prestige™ included the followings:
- Flexural Strength
- · Depth of Cure
- Sensitivity to Ambient Light
- Diametral Strength
- Water Sorption
- Shade and Color Stability
- Radiopacity
The substantial equivalence or suitability to the intended purpose of Prestige™ has been demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices currently on the market. Results of our bench testing indicate that Prestige™ has the same performance and technological characteristics.
Summary of the differences between the subject and the predicate devices
Three main differences between Prestige™ and Herculite XR & XRV are:
- Increased radiopacity
- · Different initiating
- Decreased film thickness
Conclusion: F.
Our records indicate that our predicates have been used by dentists and large group practices in the United States and purchased by a large number of international distributors.
In conclusion, the differences between the subject device and the predicate device do not affect substantial equivalence, or raise different questions of substantial
5
Image /page/5/Picture/0 description: The image contains the logo for Danville Engineering & Materials. The logo features a blue square with a white design inside, followed by the word "Danville" in large, bold, black letters. Below "Danville" is the text "ENGINEERING & MATERIALS" in smaller, black letters.
3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA
equivalence. The subject device, Prestige™ has been designed and manufactured with the intended use and claims for the product in mind. Prestige™ is substantially equivalent to the predicate device and may be released to the market.