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 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.

AI/ML Overview

The provided text describes the regulatory clearance of a dental device, "TurboTemp EZ," and includes information relevant to its performance testing and comparison to predicate devices, rather than a study proving the device meets acceptance criteria in terms of algorithm performance for an AI/ML device.

Based on the content provided, here's an analysis structured according to your request, with the understanding that this is for a physical medical device, not an AI/ML algorithm:

1. A table of acceptance criteria and the reported device performance

For a physical dental material, acceptance criteria often relate to physical, chemical, and biological properties, usually benchmarked against industry standards or predicate devices.

Acceptance Criteria (from predicate/standards)	Reported Device Performance (TurboTemp EZ)
Transverse Strength (Typically >= 100 MPa from predicate/standards)	94 MPa
Water Sorption (Typically <= 20 ug/mm³ from predicate/standards)	17.111 ug/mm³
Compliance to ISO 10477 (Dentistry - Polymer-Based Crown and Veneering Materials)	Demonstrated compliance
Compliance to ISO 4049 (Dentistry - Polymer-Based Restorative Materials)	Demonstrated compliance
Biocompatibility (Compliance to ISO 7405, ISO 10993-1, and FDA guidance for Dental Composite Resin Devices)	Demonstrated compliance
Indications for Use (Match predicate)	Same as predicate
Curing Features (Match predicate)	Self-curing (predicate offers self-curing & dual-curing)
Resin & Fillers (Same type as predicate)	Dimethacrylate resin, Silica-based glass fillers
Mode of Operation (Same as predicate)	Dual-barrel cartridge

Note: While the Transverse Strength of TurboTemp EZ (94 MPa) is slightly lower than the predicate (100 MPa), the FDA deemed it "substantially equivalent." This suggests the overall profile of properties, including compliance with standards, was considered acceptable for the intended use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the physical and chemical performance tests (e.g., transverse strength, water sorption) or the provenance of the data. It merely states that "Performance testing of TurboTemp EZ has demonstrated compliance" to certain ISO standards and FDA guidance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the document describes a physical dental material, not an AI/ML device requiring expert ground truth for image or data interpretation. The "ground truth" for this type of device is established through standardized laboratory testing and material characterization.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI/ML device involving human interpretation or adjudication of outputs.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this physical device, the "ground truth" is based on:

Standardized laboratory measurements: Physical properties like transverse strength and water sorption are measured objectively using established methods defined in ISO standards (e.g., ISO 10477, ISO 4049).
Biocompatibility testing: Compliance with ISO 7405 and ISO 10993-1, which involves standardized biological evaluations to ensure safety when in contact with human tissue.
Comparison to predicate device: The characteristics of the legally marketed predicate device (Luxatemp Ultra) serve as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device. The "training set" concept is not relevant here.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/ML device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
X 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: (760) 743-7744 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

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

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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)Number	TBD	K101710	✓
Name	TurboTemp EZ	Luxatemp Ultra	✓
Manufacturer	Zest Dental Solutions	DMG USA, Inc	✓
Indicationsfor Use	TurboTemp EZ is a is a self-cure crown-and-bridgecomposite indicated for thefabrication of long- andshort-term provisionalrestorations includingveneers, inlays/onlays,crowns, partial crowns,bridges and long-spanbridges. TurboTemp EZ isalso indicated forincorporation of mostmechanically anchoredattachment components intothe acrylic base of a denture,an overdenture, or a partialdenture.	Luxatemp Ultra/Star is a self-curing or dual-curingcomposite for the fabricationof temporary crowns andbridges, inlays, onlays andveneers.Luxatemp Ultra/Star isintended for the fabricationof:• temporary crowns• bridges• inlays• onlays• long-term temporaries• temporary veneersLuxatemp Ultra/Star is alsoindicated for incorporation ofmost mechanically anchoredattachment components intothe acrylic base of a denture,an overdenture or partialdenture.	✓
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 ofOperation	Dual-barrel cartridge	Dual-barrel cartridge	✓
Resin System	Dimethacrylate	Dimethacrylate	✓
Fillers	Silica-based glass fillers	Glass fillers	✓
TransverseStrength	94 MPa	100 MPa	✓
WaterSorption	$17.111 \mu g/mm^3$	$20 u/mm^3$	✓
Components	2	2	✓

CONFIDENTIAL

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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

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
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.(b)
Classification. Class II.