(65 days)
Not Found
No
The summary describes a dental milling block material and its physical properties, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a material for fabricating dental restorations (inlays, onlays, veneers, full crowns), not a device used directly for treating a disease or condition.
No
The device is a nanohybrid composite material used for fabricating dental restorations (inlays, onlays, veneers, crown restorations), which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "nanohybrid composite material" and a "milling block," indicating it is a physical material used for fabricating dental restorations, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating dental restorations (inlays, onlays, veneers, full crowns) for placement in the mouth. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The device is a material (nanohybrid composite) used to create physical dental prosthetics. It does not interact with biological samples (like blood, urine, or tissue) for the purpose of diagnosis.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information. The performance studies focus on material properties relevant to dental restorations (strength, solubility, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
CAD/CAMouflage Milling Block is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The CAD/CAMouflage Milling Block is made for fabricating temporary and permanent restorations such as inlays, onlays, veneers and full crown restorations.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
The CAD/CAMouflage Milling Block is a nanohybrid composite material that is designed as an indirect restorative for both anterior and posterior restorations including occlusal surfaces. The CAD/CAMouflage Milling Block is made for fabricating indirect restorations such as inlays, onlays, veneers and full crown restorations. The mandrel is solely to aid in the manipulation of the material during processing (grinding, shaping, cutting, etc.). It is removed prior to the material (subject device) being put into final placement. As such, there are no implications for device performance or safety, since it is removed, and it has no patient contact.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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 test data was used to support the substantial equivalency. Specifically, the CAD/CAMouflage Milling Blocks were evaluated using the relevant FDA recognized standard: ISO 4049: 2009 Dentistry - Polymer-based restorative materials. In addition. Prismatik utilized the FDA's Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions. To provide evidence and assurance for the device safety and meeting the ISO 4049 and ISO 10477:2004(E) requirements, Prismatik performed various tests including the Flexural Strength, Water Sorption and Solubility, Radio Opacity, Shade Stability, Diametral Strength, Compressive Strength. Biocompatibility was provided in the predicate device.
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.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2016
Prismatik Dentalcraft, Inc. Lisa Maloney Sr. Manager, Regulatory Affairs 2212 Dupont Drive, Suite P Irvine, California 92612
Re: K162537
Trade/Device Name: CAD/CAMouflage Milling Block Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: October 14, 2016 Received: October 17, 2016
Dear Ms. Lisa Maloney:
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
1
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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | |
|---|---|
| Device Name | CAD/CAMouflage Milling Block |
| Indications for Use (Describe) | CAD/CAMouflage Milling Block is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The CAD/CAMouflage Milling Block is made for fabricating temporary and permanent restorations such as inlays, onlays, veneers and full crown restorations. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 and complete 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
"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."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
. The
Armaria
lər Bərək Qaraq Qaran Qaran Qaran Qaran Qara Qaran Qara Qara Qara Qara Qara Qara Qara Qara Qara Qara Qara Qara Qara Qara Qara Qara Qara Qara Qara
3
Image /page/3/Picture/0 description: The image shows the logo for PRISMATIK DENTALCRAFT, INC. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
SUBMITTER INFORMATION A.
| Company Name: | Prismatik Dentalcraft, Inc. |
|---|---|
| Company Address: | 2212 Dupont Dr., Suite P. |
| Irvine, CA 92612 | |
| Company Phone: | 949-440-2636 |
| Company FAX: | 949-553-0924 |
| Facility Registration Number: | 3005477956 |
| Primary Contact Person: | Aliva Das, (949) 225-1249 |
| Regulatory Affairs Associate | |
| Secondary Contact Person | Lisa Maloney, (949) 440-2631 |
| Sr. Manager, Regulatory Affairs | |
| Date Summary Prepared: | October 14, 2016 |
B. DEVICE IDENTIFICATION
| Trade/Proprietary Name: | CAD/CAMouflage Milling Block |
|---|---|
| Common Name: | Tooth Shade Resin Material |
| Classification Code: | Class II, 21 CFR 872.3690 |
| Classification Name: | Tooth Shade Resin Material |
| Product Code: | EBF |
| Panel: | Dental |
4
C. IDENTIFICATION OF PREDICATE DEVICE
| Trade/Proprietary Name: | CAD/CAMouflage Milling Block |
|---|---|
| Predicate Device: | CAD/CAMouflage Milling Block |
| Predicate Clearance Number/Date: | K160425; July 15, 2016 |
D. DEVICE DESCRIPTION
The CAD/CAMouflage Milling Block is a nanohybrid composite material that is designed as an indirect restorative for both anterior and posterior restorations including occlusal surfaces. The CAD/CAMouflage Milling Block is made for fabricating indirect restorations such as inlays, onlays, veneers and full crown restorations. The mandrel is solely to aid in the manipulation of the material during processing (grinding, shaping, cutting, etc.). It is removed prior to the material (subject device) being put into final placement. As such, there are no implications for device performance or safety, since it is removed, and it has no patient contact.
E. INDICATIONS FOR USE
CAD/CAMouflage Milling Block is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The CAD/CAMouflage Milling Block is made for fabricating temporary and permanent restorations such as inlays, onlays, veneers and full crown restorations.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE F. PROPOSED DEVICE AND THE PREDICATE DEVICES
Prismatik utilized the FDA's Guidance for Industrv and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions for comparing its CAD/CAMouflage Milling Blocks with the Primary Device: CAD/CAMouflage Milling Block (K160425) cleared on July 15, 2016. There are no changes in the technological characteristics of the proposed device, and the predicate device. Outlined below are the similarities and the substantial equivalency of the CAD/CAMouflage Milling Blocks and the cited predicate device:
5
Comparison of Technological Characteristics of the Proposed Device and the Predicate Devices
| Attributes | Predicate Device: 510(k)
K160425
CAD/CAMouflage
Milling Block
Prismatik Dentalcraft, Inc. | Proposed Device:
CAD/CAMouflage Milling
Block | Similarities
&
Differences | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--|
| FDA
Classification
Name | Tooth shade resin material | Tooth shade resin material | Same | |
| FDA Product
Code | EBF | EBF | Same | |
| FDA Device
Classification | Class II per 21 CFR 872.3690 | Class II per 21 CFR 872.3690 | Same | |
| Chemical
Composition | Composite Restorative Material | Composite Restorative Material | Same | |
| Final Vita Shades | A2 LT | A1 HT,A2 HT,A3 HT,A3.5 HT, B1
HT, A1 LT, BL LT, A3 LT, A3.5
LT, B1 LT, C2 LT, D2 LT, | Different | |
| Intended Use | Intended to restore carious
lesions or structural defects in
teeth | Intended to restore carious lesions
or structural defects in teeth | Same | |
| Indications | CAD/CAMouflage Milling
Block is indicated as an indirect
restorative for both anterior and
posterior restorations, including
occlusal surfaces. The
CAD/CAMouflage Milling
Block is made for fabricating
temporary and permanent
restorations such as inlays,
onlays, veneers and full crown
restorations. | CAD/CAMouflage Milling Block is
indicated as an indirect restorative
for both anterior and posterior
restorations, including occlusal
surfaces. The CAD/CAMouflage
Milling Block is made for
fabricating temporary and
permanent restorations such as
inlays, onlays, veneers and full
crown restorations. | Same | |
| Biocompatibility | Biocompatible | Biocompatible | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Single or
Multiple Use | Single use | Single use | Same | |
| Prescription/OTC
Use | Prescription | Prescription | Same | |
| Substantial
Equivalence | The proposed device has the same indications, intended use, biocompatibility, and
chemical composition, mechanical and chromatic properties to the predicate device. We
consider the proposed device to be substantially equivalent to the predicate device, and
believe any differences between the proposed and predicate devices will not pose new
safety or effectiveness concerns. The intended use of the modified device has not
changed as a result of the modification. | | | |
6
DETERMINATION OF SUBSTANTIAL EQUIVALENCE G.
The comparison table above outlines and provides the similarities and substantial equivalency of the technological characteristics of the predicate device. CAD/CAMouflage Milling Block K160425 and the proposed device CAD/CAMouflage Milling Block. Prismatik believes that the comparative data presented, demonstrate that the CAD/CAMouflage Milling Blocks are essentially the same as currently marketed devices for the same intended use, indications for use, and supports our claim of substantial equivalence to predicate Class II devices under the classification of 21 CFR 872.3690 that have previously been found to be substantially equivalent. The proposed and predicate devices consist of the same Product Code: EBF, and are biocompatible for the same indications for use. The only change is to include the additional shades to the CAD/CAMouflage Milling Blocks.
SUMMARY OF NON-CLINICAL TESTING H.
Non-clinical test data was used to support the substantial equivalency. Specifically, the CAD/CAMouflage Milling Blocks were evaluated using the relevant FDA recognized standard: ISO 4049: 2009 Dentistry - Polymer-based restorative materials. In addition. Prismatik utilized the FDA's Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions. To provide evidence and assurance for the device safety and meeting the ISO 4049 and ISO 10477:2004(E) requirements, Prismatik performed various tests including the Flexural Strength, Water Sorption and Solubility, Radio Opacity, Shade Stability, Diametral Strength, Compressive Strength. Biocompatibility was provided in the predicate device.
I. CONCLUSION FROM THE NON-CLINICAL TESTING
The results of the above-described studies demonstrate that the CAD/CAMouflage Milling Blocks are substantially equivalent to the cleared Primary Device: CAD/CAMouflage Milling Blocks: K160425.
The modification for our CAD/CAMouflage Milling Block is to add additional shades as provided in the Comparison Table above.