CAD/CAMouflage Milling Bock

K160425 · Prismatik Dentalcraft, Inc. · EBF · Jul 15, 2016 · Dental

Device Facts

• Record ID: K160425
• Device Name: CAD/CAMouflage Milling Bock
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: EBF · Dental
• Decision Date: Jul 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

CAD/CAMouflage Milling Block is a nanohybrid composite material used by dental professionals to fabricate indirect dental restorations. The material is supplied as a block, which is shaped via CAD/CAM milling processes into the desired restoration (inlays, onlays, veneers, crowns). A mandrel is attached to the block to facilitate handling during the milling/shaping process and is removed prior to final placement in the patient's mouth. The device is used in a clinical or laboratory setting. The final restoration is placed by a dentist to restore carious lesions or structural defects in teeth. The device provides a durable, tooth-colored restorative solution, benefiting patients by restoring tooth function and aesthetics.

Clinical Evidence

Bench testing only. Testing included flexural strength, water sorption, solubility, radio opacity, shade stability, diametral strength, compressive strength, and biocompatibility, performed in accordance with ISO 4049:2009 and ISO 10477:2004(E).

Technological Characteristics

Nanohybrid composite resin material. Form factor: milling block with removable mandrel. Biocompatible. Non-sterile. Complies with ISO 4049:2009 and ISO 10477:2004(E) standards for polymer-based restorative materials.

Indications for Use

Indicated for patients requiring indirect anterior or posterior restorations, including occlusal surfaces, inlays, onlays, veneers, and full crown restorations (temporary or permanent).

Regulatory Classification

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.

Predicate Devices

• CERASMART (K133824)

Reference Devices

• Camouflage Nanohybrid Composite (K133850)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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.<br>Irvine, CA 92612 |
| Company Phone: | 949-440-2636 |
| Company FAX: | 949-553-0924 |
| Facility Registration Number: | 3005477956 |
| Primary Contact Person: | Maria E Wagner, [phone]<br>Senior Specialist, Regulatory Affairs |
| Secondary Contact Person | Lisa Maloney, [phone]<br>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.

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## Comparison of Technological Characteristics of the Proposed Device and the Predicate Devices

| Attributes | Reference Device:<br>Camouflage<br>NanoHybrid<br>Composite<br>510(k)-K133850<br>Prismatik Dentalcraft,<br>Inc. | Predicate Device:<br>Cerasmart<br>510(k)-K133824<br>GC AMERICA,<br>INC. | Proposed<br>Device:<br>CAD/CAMou<br>flage Milling<br>Blocks<br>Prismatik<br>Dentalcraft,<br>Inc. | Similarities &<br>Differences |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| FDA<br>Classification<br>Name | Tooth shade resin<br>material | Tooth shade resin<br>material | Tooth shade<br>resin material | Same |
| FDA Product<br>Code | EBF | EBF, EBG | EBF, EBG | Similar to Predicate<br>Device<br>Same as Reference<br>Device |
| FDA Device<br>Classification | Class II per 21 CFR<br>872.3690 | Class II per 21 CFR<br>872.3690 | Class II per 21 CFR<br>872.3690 | Same |
| Chemical<br>Composition | Composite Restorative<br>Material | Composite<br>Restorative Material | Composite Restorative<br>Material | Similar to Predicate<br>Device: Similar to<br>Reference Device |
| Intended Use | Intended to restore<br>carious lesions or<br>structural defects in<br>teeth | The product is<br>indicated for inlays,<br>onlays, veneers and<br>full crown<br>restorations,<br>including crowns<br>on implants | Intended to restore<br>carious lesions or<br>structural defects in<br>teeth | Same as Predicate<br>Device; Similar to<br>Reference Device |
| Indications | Cavity classes I, II, III,<br>IV, V and VI in anterior<br>and posterior teeth; used<br>as direct restorative<br>material; can use for<br>fabrication of inlays and<br>onlays | Indicated for inlays,<br>onlays, veneers and<br>full crown<br>restorations,<br>including crowns on<br>implants | CAD/CAMouflage<br>Milling Block is<br>indicated as an indirect<br>restorative for both<br>anterior and posterior<br>restorations, including<br>occlusal surfaces. The<br>CAD/CAMouflage<br>Milling Block is made<br>for fabricating<br>temporary and<br>permanent restorations<br>such as inlays, onlays,<br>veneers and full crown<br>restorations. | Same as Predicate<br>Device; Similar to<br>Reference Device |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Same |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single or<br>Multiple Use | Single Patient, multiple<br>use | Single Patient,<br>multiple use | Single Patient, multiple<br>use | Same |
| Prescription/OCT<br>Use | Prescription | Prescription | Prescription | Same |
| Substantial<br>Equivalence | The proposed device has comparable indications, intended use, biocompatibility, chemical<br>composition, mechanical and chromatic properties to the predicate device, and has similar<br>characteristics to the reference device. We consider the proposed device to be substantially<br>equivalent to the predicate device, and believe any differences between the proposed and predicate<br>& 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.