(150 days)
Camouflage Nanohybrid Composite-K133850
No
The summary describes a dental milling block material and its physical properties, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
No.
The device is a milling block used to fabricate dental restorations; it is not directly applied to a patient for a therapeutic purpose.
No
The device is a nanohybrid composite material used as an indirect restorative for fabricating temporary and permanent dental restorations. It is not used for diagnosing medical conditions.
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/Indications for Use: The device is intended for fabricating dental restorations (inlays, onlays, veneers, 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) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing information about a patient's health status.
- Performance Studies: The performance studies focus on material properties relevant to dental restorations (flexural strength, water sorption, radiopacity, etc.), not diagnostic accuracy.
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, EBG
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, including crowns. 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
anterior and posterior teeth (for restorations)
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 testing including the Flexural Strength, Water Sorption and Solubility, Radio Opacity, Shade Stability, Diametral Strength, Compressive Strength and biocompatibility.
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.
CERASMART ™ -K133824
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.
Camouflage Nanohybrid Composite-K133850
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July15, 2016
Prismatik Dentalcraft, Inc. Maria Wagner Senior RA 2212 Dupont Drive, Suite P Irvine, California 92612
Re: K160425
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: June 15, 2016 Received: June 16, 2016
Dear Ms. Wagner:
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 I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160425
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) |
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Image /page/3/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a rainbow gradient. To the right of the triangle is the company name, "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the second line. The text is in a blue 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: | Maria E Wagner, (949) 440-2636 |
| Senior Specialist, Regulatory Affairs | |
| Secondary Contact Person | Lisa Maloney, (949) 440-2631 |
| Sr. Manager, Regulatory Affairs | |
| Date Summary Prepared: | July 14, 2016 |
DEVICE IDENTIFICATION B.
| Trade/Proprietary Name: | CAD/CAMouflage Milling Block |
|---|---|
| Reference: | 21 CFR 872.3690 |
| Classification Name: | Material, Tooth Shade Resin |
| Classification: | Class II |
| Product Code: | EBF, EBG |
| Panel: | Dental |
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C. IDENTIFICATION OF PREDICATE DEVICE
| Trade/Proprietary Name: | CAD/CAMouflage Milling Block |
|---|---|
| Primary Device: | CERASMART ™ -K133824 |
| Reference Device: | Camouflage Nanohybrid Composite-K133850 |
DEVICE DESCRIPTION D.
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, including crowns. 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.
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE PROPOSED DEVICE AND THE PREDICATE DEVICES
Prismatik utilized the FDA's Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions for comparing its CAD/CAMouflage Milling Blocks with the Primary Device: CERASMART™ and reference device: Prismatik's Camouflage Nanohybrid Composite. The following comparison table of the technological characteristics of the proposed device, the predicate and reference devices outlines and provides the similarities and the substantial equivalency of the CAD/CAMouflage Milling Blocks and the cited predicate and reference devices.
5
Comparison of Technological Characteristics of the Proposed Device and the Predicate Devices
| Attributes | Reference Device:
Camouflage
NanoHybrid
Composite
510(k)-K133850
Prismatik Dentalcraft,
Inc. | Predicate Device:
Cerasmart
510(k)-K133824
GC AMERICA,
INC. | Proposed
Device:
CAD/CAMou
flage Milling
Blocks
Prismatik
Dentalcraft,
Inc. | Similarities &
Differences |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| FDA
Classification
Name | Tooth shade resin
material | Tooth shade resin
material | Tooth shade
resin material | Same |
| FDA Product
Code | EBF | EBF, EBG | EBF, EBG | Similar to Predicate
Device
Same as Reference
Device |
| FDA Device
Classification | Class II per 21 CFR
872.3690 | Class II per 21 CFR
872.3690 | Class II per 21 CFR
872.3690 | Same |
| Chemical
Composition | Composite Restorative
Material | Composite
Restorative Material | Composite Restorative
Material | Similar to Predicate
Device: Similar to
Reference Device |
| Intended Use | Intended to restore
carious lesions or
structural defects in
teeth | The product is
indicated for inlays,
onlays, veneers and
full crown
restorations,
including crowns
on implants | Intended to restore
carious lesions or
structural defects in
teeth | Same as Predicate
Device; Similar to
Reference Device |
| Indications | Cavity classes I, II, III,
IV, V and VI in anterior
and posterior teeth; used
as direct restorative
material; can use for
fabrication of inlays and
onlays | Indicated for inlays,
onlays, veneers and
full crown
restorations,
including crowns on
implants | 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 as Predicate
Device; Similar to
Reference Device |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Same |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single or
Multiple Use | Single Patient, multiple
use | Single Patient,
multiple use | Single Patient, multiple
use | Same |
| Prescription/OCT
Use | Prescription | Prescription | Prescription | Same |
| Substantial
Equivalence | The proposed device has comparable indications, intended use, biocompatibility, chemical
composition, mechanical and chromatic properties to the predicate device, and has similar
characteristics to the reference device. We consider the proposed device to be substantially
equivalent to the predicate device, and believe any differences between the proposed and predicate
& reference devices will not pose new equvalency concerns. | | | |
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G. DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The above comparison table of the technological characteristics of the proposed device and the predicate and reference devices was provided for the substantial equivalency of the CAD/CAMouflage Milling Blocks with the Primary Device: CERASMART™-K133824 and the referenced device: Prismatik's Camouflage Nanohybrid Composite-K133850, and reference device: 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 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, the predicate and reference devices consist of the same/similar Product Code: EBF, EBG, which are biocompatible for the same indications for use.
H. SUMMARY OF NON-CLINICAL TESTING
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 testing including the Flexural Strength, Water Sorption and Solubility, Radio Opacity, Shade Stability, Diametral Strength, Compressive Strength and biocompatibility.
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: CERASMART™-K133824 and reference device: Prismatik's Camouflage Nanohybrid Composite-K133850.