(167 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a dental composite, with no mention of AI or ML technologies.
No
This device is a dental restorative material, used to fill cavities in teeth, which is not considered a therapeutic device because it does not treat or cure a disease.
No
The device is a restorative material used for filling cavities and fabricating inlays and onlays, which are treatment procedures rather than diagnostic ones.
No
The device description clearly states it is a light-cured resin-based composite restorative material, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for restoring cavities in teeth, which is a direct treatment on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The description details a material used for filling cavities, not for analyzing biological samples.
- Anatomical Site: The anatomical site is teeth, which are part of the patient's body.
- Performance Studies: The performance studies focus on the physical and chemical properties of the material (strength, water absorption, etc.) and its ability to cure and bond to tooth structure, not on diagnostic accuracy or analysis of biological samples.
The device is a dental restorative material, which is a type of medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Camouflage NanoHybrid Composite (Universal and Flowable) are indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth.
· May be used as a direct restorative material
· May be used for fabrication of inlays and onlays
Product codes
EBF
Device Description
The Camouflage Nanohybrid Composite (Universal and Flowable) is a light cured resin-based composite restorative. It is offered in High Viscosity ("Camouflage Universal" paste) and Low Viscosity (Camouflage Flowable), and is recommended for direct and indirect placement in all caries classes (both anterior and posterior restorations, including occlusal surfaces). It is available in multiple shades and opacities, and is radioopaque. It is composed of methacrylate monomers, Initiators, inhibitors, stabilizers, pigments, and inorganic fillers coated with a coupling agent. The Camouflage Nanohybrid Composite (Universal and Flowable) cures with light in the wavelength range of 400-500nm, and a dental adhesive is used to permanently bond the restoration to the tooth structure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior 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 Camouflage Nanohybrid Composite (Universal and Flowable) was 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, assurance for the device safety and meeting the ISO 4049 requirements. Prismatik performed various testing including the Sensitivity to Ambient Light, Depth of Cure, Flexural Strength/Elastic Modulus, Water Absorption, Water Solubility, Shade Match/Shade Stability and Radio Opacity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The company name is written in a bold, sans-serif font.
.
005-510(k) Summary-807.92(c)
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
.
SUBMITTER INFORMATION A.
| Company Name: | Prismatik Dentalcraft, Inc. |
|---|---|
| Company Address: | 2212 Dupont Dr., Suite IJK, |
| Irvine, CA 92612 | |
| Company Phone: | 949-225-1269 |
| Company FAX: | 949-553-0924 |
| Facility Registration Number: | 3005477956 |
| Primary Contact Person: | Armin Zehtabchi, (949) 225-1234 |
| Senior RA | |
| Secondary Contact Person | Marilyn Pourazar, (949) 225-1269 |
| Senior Director, RA/QA | |
| Date Summary Prepared: | June 3, 2014 |
DEVICE IDENTIFICATION B.
| Trade/Proprietary Name: | Camouflage NanoHybrid Composite (Universal and
Flowable) |
|-------------------------|-------------------------------------------------------------|
| 21 CFR Reference: | 21 CFR 872.3690 |
| 21 CFR Common Name: | Tooth shade resin material |
| Classification: | Class II |
| Product Code: | EBF |
| Panel: | Dental |
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C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name:
Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221
DEVICE DESCRIPTION D.
The Camouflage Nanohybrid Composite (Universal and Flowable) is a light cured resin-based composite restorative. It is offered in High Viscosity ("Camouflage Universal" paste) and Low Viscosity (Camouflage Flowable), and is recommended for direct and indirect placement in all caries classes (both anterior and posterior restorations, including occlusal surfaces). It is available in multiple shades and opacities, and is radioopaque. It is composed of methacrylate monomers, Initiators, inhibitors, stabilizers, pigments, and inorganic fillers coated with a coupling agent. The Camouflage Nanohybrid Composite (Universal and Flowable) cures with light in the wavelength range of 400-500nm, and a dental adhesive is used to permanently bond the restoration to the tooth structure.
INDICATIONS FOR USE E.
The Camouflage NanoHybrid Composite (Universal and Flowable) are indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth.
· May be used as a direct restorative material
· May be used for fabrication of inlays and onlays
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 Camouflage NanoHybrid Composite (Universal and Flowable) with the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221, The following comparison table of the technological characteristics of the proposed device and the predicate device outlines and provides the similarities and the substantial equivalency of the Camoutlage NanoHybrid Composite (Universal and Flowable) and the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221.
2
| | Predicate Device:
Composite 168
Restorative System
(EsthetXHD/Flow)
Dentsply
510(k)-K973221 | Proposed Device:
Camouflage Nanohybrid
Composite
(Universal and Flowable) | Similarities
and
Difference
Between the
Predicate and
the Subject
Device |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Classification of
Polymer | Per ISO 4049
Type-1
Class-2
Group- 1&2
(Per ISO 4049) | Per ISO 4049
Type-1
Class-2
Group- 1&2
(Per ISO 4049) | Same |
| Intended Uses Per
FDA Regulation | Intended to restore carious
lesions or structural defects
in teeth | Intended to restore carious
lesions or structural defects in
teeth | Same |
| Indications for use
per 510k
Clearance Letter | • Indicated for cavity
classes I, II, III, IV, V, and
VI in anterior and posterior
teeth.
• May be used as a direct
restorative material
• May be used for
fabrication of inlays and
onlays | • Indicated for cavity classes I,
II, III, IV, V, and VI in
anterior and posterior teeth.
• May be used as a direct
restorative material
• May be used for fabrication
of inlays and onlays | Same |
| FDA Description
and Product Code
Information | EBF
21 CFR 872.3690
Tooth shade resin material | EBF
21 CFR 872.3690
Tooth shade resin material | Same |
| General Material | Tooth shade resin material | Tooth shade resin material | Same |
| Delivery | • Syringes | • Syringes | Same |
| Method(s) | • Capsules Tips | • Capsules Tips | Same |
| Biocompatibility | Biocompatible | Biocompatible | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Single or Multiple
Use | Single Patient, multiple use | Single Patient, multiple use | Same |
| Prescription/OCT
Use | Prescription | Prescription | Same |
Comparison of the Technological Characteristics of the Proposed and the Predicate Devices
G. DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The above comparison table of the technological characteristics of the proposed device and the predicate devices was provided for the substantial equivalency of the Camouflage NanoHybrid Composite (Universal and Fiowable) and the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221. Prismatik believes that the comparative
3
data presented, demonstrate that the Camouflage NanoHybrid Composite (Universal and Flowable) is 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. Both the proposed and the predicate device consist of the same Product Code: EBF, which is 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 Camouflage Nanohybrid Composite (Universal and Flowable) was 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, assurance for the device safety and meeting the ISO 4049 requirements. Prismatik performed various testing including the Sensitivity to Ambient Light, Depth of Cure, Flexural Strength/Elastic Modulus, Water Absorption, Water Solubility, Shade Match/Shade Stability and Radio Opacity.
CONCLUSION FROM THE NON-CLINICAL TESTING I.
The results of the above described studies demonstrate that the Camouflage NanoHybrid Composite (Universal and Flowable) is substantially equivalent to the cleared predicate device, the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
June 4, 2014
Prismatik Dentalcraft, Inc. C/O Mr. Armin Zehtabchi Senior Regulatory Analyst 2212 Dupont Drive, Suite IJK Irvine, CA 92612
Re: K133850
Trade/Device Name: Camouflage Nanohybrid Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade, resin Regulatory Class: Il Product Code: EBF Dated: April 29, 2014 Received: April 30, 2014
Dear Mr. Zehtabchi:
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. Zehtabchi
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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.
MarylSTByner-S
Erin I. Keith, M.S. Division 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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Page 12 of 186
004-Indications for Use Statement
510(k) Number (if known): To be determined
Camouflage Nanol lybrid Composite (Universal and Flowable) Device Name:
Indications for Use: The Camouflage NanoHybrid Composite (Universal and Flowable) are indicated for cavity classes I, II, III, IV. V, and VI in anterior and posterior teeth.
· May be used as a direct restorative material
· May be used for fabrication of inlays and onlays
| Prescription Use: | Yes X No |
|---|---|
| (Part 21 CFR 801 Subpart D) |
Over-the-Counter Use: Yes | No Z (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green:=S
2014.06.03 14:52:53-04'00'