CAD/CAMouflage Milling Block

K162537 · Prismatik Dentalcraft, Inc. · EBF · Nov 16, 2016 · Dental

Device Facts

• Record ID: K162537
• Device Name: CAD/CAMouflage Milling Block
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: EBF · Dental
• Decision Date: Nov 16, 2016
• Decision: SESE
• Submission Type: Special
• 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 for fabricating indirect dental restorations; anterior/posterior teeth; inlays, onlays, veneers, full crowns. Material is processed via CAD/CAM milling (grinding, shaping, cutting) using a mandrel for manipulation, which is removed prior to final placement. Device is used in dental clinics/labs by dental professionals. Output is a custom-milled dental restoration; provides structural repair for carious lesions or defects. Benefits include restoration of tooth function and aesthetics.

Clinical Evidence

Bench testing only. Evaluated per ISO 4049:2009 and ISO 10477:2004(E). Tests included flexural strength, water sorption, solubility, radio opacity, shade stability, diametral strength, and compressive strength. Biocompatibility data relied on the predicate device.

Technological Characteristics

Nanohybrid composite resin material. Non-sterile, single-use. Complies with ISO 4049:2009 and ISO 10477:2004(E). Form factor is a milling block with a removable mandrel for processing.

Indications for Use

Indicated for patients requiring indirect anterior or posterior dental restorations, including occlusal surfaces, inlays, onlays, veneers, and full crowns.

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

• CAD/CAMouflage Milling Block (K160425)

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

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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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) | <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:black;" width="12"></rect> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:white;stroke:black;stroke-width:1" width="12"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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

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#### 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:

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

| Attributes | Predicate Device: 510(k)<br>K160425<br>CAD/CAMouflage<br>Milling Block<br>Prismatik Dentalcraft, Inc. | Proposed Device:<br>CAD/CAMouflage Milling<br>Block | Similarities<br>&<br>Differences | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--|
| FDA<br>Classification<br>Name | Tooth shade resin material | Tooth shade resin material | Same | |
| FDA Product<br>Code | EBF | EBF | Same | |
| FDA Device<br>Classification | Class II per 21 CFR 872.3690 | Class II per 21 CFR 872.3690 | Same | |
| Chemical<br>Composition | Composite Restorative Material | Composite Restorative Material | Same | |
| Final Vita Shades | A2 LT | A1 HT,A2 HT,A3 HT,A3.5 HT, B1<br>HT, A1 LT, BL LT, A3 LT, A3.5<br>LT, B1 LT, C2 LT, D2 LT, | Different | |
| Intended Use | Intended to restore carious<br>lesions or structural defects in<br>teeth | Intended to restore carious lesions<br>or structural defects in teeth | Same | |
| Indications | CAD/CAMouflage Milling<br>Block is indicated as an indirect<br>restorative for both anterior and<br>posterior restorations, including<br>occlusal surfaces. The<br>CAD/CAMouflage Milling<br>Block is made for fabricating<br>temporary and permanent<br>restorations such as inlays,<br>onlays, veneers and full crown<br>restorations. | CAD/CAMouflage Milling Block is<br>indicated as an indirect restorative<br>for both anterior and posterior<br>restorations, including occlusal<br>surfaces. The CAD/CAMouflage<br>Milling Block is made for<br>fabricating temporary and<br>permanent restorations such as<br>inlays, onlays, veneers and full<br>crown restorations. | Same | |
| Biocompatibility | Biocompatible | Biocompatible | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Single or<br>Multiple Use | Single use | Single use | Same | |
| Prescription/OTC<br>Use | Prescription | Prescription | Same | |
| Substantial<br>Equivalence | The proposed device has the same indications, intended use, biocompatibility, and<br>chemical composition, mechanical and chromatic properties to the predicate device. We<br>consider the proposed device to be substantially equivalent to the predicate device, and<br>believe any differences between the proposed and predicate devices will not pose new<br>safety or effectiveness concerns. The intended use of the modified device has not<br>changed as a result of the modification. | | | |

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#### 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.