TurboTemp EZ

K191619 · Zest Anchors, LLC · EBG · Sep 11, 2019 · Dental

Device Facts

• Record ID: K191619
• Device Name: TurboTemp EZ
• Applicant: Zest Anchors, LLC
• Product Code: EBG · Dental
• Decision Date: Sep 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TurboTemp EZ is a is a self-cure crown-and-bridge composite indicated for the fabrication of long- and short-term provisional restorations including veneers, inlays/onlays, crowns, bridges and long-span bridges. TurboTemp EZ is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or a partial denture.

Device Story

TurboTemp EZ is a self-cure, dimethacrylate-based composite resin for dental provisional restorations. Provided in a dual-barrel cartridge; dispensed via mixing tip. Used by dental professionals in clinical settings to fabricate crowns, bridges, inlays, onlays, and veneers, or to anchor attachment components into dentures. Material cures upon mixing; provides temporary structural support for dental prosthetics. Benefits include efficient chairside fabrication of provisional restorations and secure integration of attachment components.

Clinical Evidence

Bench testing only. Compliance demonstrated with ISO 10477 (Polymer-Based Crown and Veneering Materials) and ISO 4049 (Polymer-Based Restorative Materials). Biological evaluation conducted per ISO 10993-1 and ISO 7405. No clinical data presented.

Technological Characteristics

Dimethacrylate resin system with silica-based glass fillers. Dual-barrel cartridge delivery system. Self-curing mechanism. Transverse strength: 94 MPa. Water sorption: 17.111 µg/mm³. Complies with ISO 10477 and ISO 4049.

Indications for Use

Indicated for patients requiring long- or short-term provisional dental restorations (veneers, inlays/onlays, crowns, bridges, long-span bridges) or incorporation of mechanically anchored attachment components into denture bases.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• Luxatemp Ultra (K101710)

Reference Devices

• DMRC Bulk Fill (Bulk EZ) (K151088)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 11, 2019

Zest Anchors, LLC Marysa Loustalot Sr. Regulatory Affairs Specialist 2875 Loker Avenue East Carlsbad, California 92010

Re: K191619

Trade/Device Name: TurboTemp EZ Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary crown and bridge resin Regulatory Class: Class II Product Code: EBG, POW Dated: June 14, 2019 Received: June 18, 2019

Dear Marysa Loustalot:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael Adjodha Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

### K191619

Device Name TurboTemp EZ

### Indications for Use (Describe)

TurboTemp EZ is a is a self-cure crown-and-bridge composite indicated for the fabrication of long- and short-term provisional restorations including veneers, inlays/onlays, crowns, bridges and long-span bridges. TurboTemp EZ is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or a partial denture.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|--|
| <span style="text-decoration: overline;">X</span> 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/0 description: The image is the logo for Zest Dental Solutions. The logo has the letters ZD in a dark blue color on the left side of the image. To the right of the letters is the text "ZEST DENTAL SOLUTIONS" in a lighter blue color. The word "ZEST" is on the top line and "SOLUTIONS" is on the bottom line.

#### Section 5.0 510(k) Summary

#### I. SUBMITTER

Zest Anchors, LLC 2875 Loker Ave. East. Carlsbad, CA 92010 Phone: [phone] Contact: Marysa Loustalot ext. 596 Date Prepared: June 14, 2019

#### II. DEVICE INFORMATION

Device / Trade Name: TurboTemp EZ Common Name: Temporary crown and bridge resin Classification Name: Crown and Bridge, Temporary Resin Regulatory Classification: 872.3770, Class II Product Code: EBG, POW

#### III. PREDICATE DEVICE

Device / Trade Name: Luxatemp Ultra 510(k): K101710 Applicant: DMG USA, INC

REFERENCE DEVICE Device / Trade Name: DMRC Bulk Fill (Bulk EZ) 510(k): K151088 Applicant: Danville Materials, LLC (Now Zest Anchors, LLC)

#### IV. DEVICE DESCRIPTION

TurboTemp EZ is a provisional resin based material intended to be used for the fabrication of crowns, bridges, inlays, onlays, and veneers. The composite material is provided in a dual-barrel cartridge that when combined in the mixing tip, it is dispensed as a self-curing restorative material.

#### V. INDICATIONS FOR USE

TurboTemp EZ is a is a self-cure crown-and-bridge composite indicated for the fabrication of long- and short-term provisional restorations including veneers, inlays/onlays, crowns, partial crowns, bridges and long-span bridges. TurboTemp EZ is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or a partial denture.

TurboTemp EZ Traditional 510(k)

## CONFIDENTIAL

ર-1

©2019 ZEST Anchors LLC. All rights reserved. Zest Dental Solutions is a registered trademark of ZEST IP Holdings, LLC.

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Image /page/4/Picture/0 description: The image is a logo for Zest Dental Solutions. The logo features the letters "ZD" in a bold, blue font on the left side of the image. To the right of the letters, the words "ZEST DENTAL" are written in a similar blue font, with the word "SOLUTIONS" written in a lighter blue font below it.

### COMPARISON TO PREDICATE DEVICE VI.

The subject device (TurboTemp EZ) has the same indications for use, the same curing features, uses the same type of resin and fillers, and has the same mode of operation as the legally marketed predicate device (Luxatemp Ultra).

| Attribute | Subject Device | Predicate Device | SE |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| 510(k)<br>Number | TBD | K101710 | ✓ |
| Name | TurboTemp EZ | Luxatemp Ultra | ✓ |
| Manufacturer | Zest Dental Solutions | DMG USA, Inc | ✓ |
| Indications<br>for Use | TurboTemp EZ is a is a self-<br>cure crown-and-bridge<br>composite indicated for the<br>fabrication of long- and<br>short-term provisional<br>restorations including<br>veneers, inlays/onlays,<br>crowns, partial crowns,<br>bridges and long-span<br>bridges. TurboTemp EZ is<br>also indicated for<br>incorporation of most<br>mechanically anchored<br>attachment components into<br>the acrylic base of a denture,<br>an overdenture, or a partial<br>denture. | Luxatemp Ultra/Star is a self-<br>curing or dual-curing<br>composite for the fabrication<br>of temporary crowns and<br>bridges, inlays, onlays and<br>veneers.<br>Luxatemp Ultra/Star is<br>intended for the fabrication<br>of:<br>• temporary crowns<br>• bridges<br>• inlays<br>• onlays<br>• long-term temporaries<br>• temporary veneers<br>Luxatemp Ultra/Star is also<br>indicated for incorporation of<br>most mechanically anchored<br>attachment components into<br>the acrylic base of a denture,<br>an overdenture or partial<br>denture. | ✓ |
| Product Code | EBG | EBG | ✓ |
| Classification | 21 CFR 872.3770 | 21 CFR 872.3770 | ✓ |
| RX/OTC | RX | RX | ✓ |
| Features | Self-curing | Self-curing & Dual-curing | ✓ |
| Mode of<br>Operation | Dual-barrel cartridge | Dual-barrel cartridge | ✓ |
| Resin System | Dimethacrylate | Dimethacrylate | ✓ |
| Fillers | Silica-based glass fillers | Glass fillers | ✓ |
| Transverse<br>Strength | 94 MPa | 100 MPa | ✓ |
| Water<br>Sorption | $17.111 \mu g/mm^3$ | $20 u/mm^3$ | ✓ |
| Components | 2 | 2 | ✓ |

# CONFIDENTIAL

©2019 ZEST Anchors LLC. All rights reserved. Zest Dental Solutions is a registered trademark of ZEST IP Holdings, LLC.

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Image /page/5/Picture/0 description: The image shows the logo for Zest Dental Solutions. The logo has the letters "ZD" in a dark blue color on the left side of the image. To the right of the letters, the words "ZEST DENTAL" are written in a dark blue color, and the word "SOLUTIONS" is written in a light blue color below the words "ZEST DENTAL".

#### VII. PERFORMANCE TESTING

Performance testing of TurboTemp EZ has demonstrated compliance to ISO 10477 Dentistry - Polymer-Based Crown and Veneering Materials, ISO 4049 Dentistry -Polymer-Based Restorative Materials, and meets the suggested characteristics as described in FDA's Guidance for Industry and FDA Staff, Dental Composite Resin Devices - Premarket Notification [510(k)] issued on October 26, 2005. Therefore it can be concluded that the TurboTemp EZ is substantially equivalent to its predicate device, Luxatemp Ultra.

The primary chemical composition of TurboTemp EZ is equivalent to the reference device DMRC Bulk Fill (commercial name, Bulk EZ) cleared under K151088. The chemicals which are contained in both devices are equivalent in quantities and serve the identical function. A biological evaluation of TurboTemp EZ has been conducted and a review of the biological properties has concluded that the TurboTemp EZ is substantially equivalent to the legally marketed Bulk EZ and complies with ISO 7405, the FDA guidance for Dental Composite Resin Devices, and ISO 10993-1.

#### VIII. CONCLUSION

Performance testing to ISO 10477 and ISO 4049, along with the biological evaluation of the subject device, demonstrate that the TurboTemp EZ is substantially equivalent to the Luxatemp Ultra (K101710).

# CONFIDENTIAL

©2019 ZEST Anchors LLC. All rights reserved. Zest Dental Solutions is a registered trademark of ZEST IP Holdings, LLC.