K Number

Device Name

TurboTemp EZ

Manufacturer

Zest Anchors, LLC

Date Cleared

2019-09-11

(85 days)

Product Code

EBG POW

Regulation Number

872.3770

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101710

Reference Devices

K151088

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a self-curing composite material for dental restorations. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section. The performance studies focus on material properties and equivalence to predicate devices, not algorithmic performance.

Therapeutic

Yes
The device is a self-cure crown-and-bridge composite indicated for the fabrication of provisional restorations and for incorporating attachment components, which are considered therapeutic functions.

Diagnostic

Explanation: The device description states that TurboTemp EZ is a provisional resin-based material for fabricating dental restorations (crowns, bridges, etc.). This indicates it is a therapeutic or restorative material, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly states it is a "provisional resin based material" and a "composite material," indicating it is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that TurboTemp EZ is for the fabrication of dental restorations (crowns, bridges, veneers, etc.) and for incorporating attachment components into dentures. This is a direct application within the patient's mouth or on a dental model, not for testing samples taken from the body.
Device Description: The description confirms it's a restorative material used for fabricating dental devices.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays for testing

The device is a dental material used for creating physical restorations, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

EBG, POW

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K101710

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K151088

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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

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

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

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	✓
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.	Luxatemp Ultra/Star is a self-
curing or dual-curing
composite for the fabrication
of temporary crowns and
bridges, inlays, onlays and
veneers.
Luxatemp Ultra/Star is
intended for the fabrication
of:
• temporary crowns
• bridges
• inlays
• onlays
• long-term temporaries
• temporary veneers
Luxatemp Ultra/Star is also
indicated for incorporation of
most mechanically anchored
attachment components into
the acrylic base of a denture,
an overdenture or partial
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
Operation	Dual-barrel cartridge	Dual-barrel cartridge	✓
Resin System	Dimethacrylate	Dimethacrylate	✓
Fillers	Silica-based glass fillers	Glass fillers	✓
Transverse
Strength	94 MPa	100 MPa	✓
Water
Sorption	$17.111 \mu g/mm^3$	$20 u/mm^3$	✓
Components	2	2	✓

CONFIDENTIAL

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

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).