SmarTemp® X I is a self-curing composite for the fabrication of temporary crowns and bridges, inlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, long-term temporaries, and temporary veneers.

Device Description

SmarTemp® X1 is a self-curing, resin-based composite, suitable for the fabrication of temporary crowns, bridges, inlays, onlays, and veneers. It is a bis-acryl resin-based material comprising a 10:1 ratio of base to catalyst components, which when expressed by the user from dual-chamber syringes or cartridges mix through standard snap-in accessory mixing tips. SmarTemp® X1 self-cures in approximately 6 minutes at mouth temperature.

SmarTemp® X1 is packaged in any standard, opaque, dual-chamber syringe or cartridge suitable for containing a 10:1 ratio of base and catalyst components, respectively. The syringe or cartridge is accompanied by standard snap-in automix tips.

AI/ML Overview

The provided text describes the regulatory clearance of a dental material, SmarTemp X1, as substantially equivalent to a predicate device, Luxatemp Ultra/Star. It does not contain information about a clinical study or acceptance criteria related to an AI/ML powered medical device.

However, based on the provided document, I can extract information related to the acceptance criteria and testing for the SmarTemp X1 dental material, which serves as a substitute for the requested AI/ML device information.

Here's the breakdown of the acceptance criteria and the study (bench performance testing) for SmarTemp® X1:

SmarTemp® X1 Acceptance Criteria and Bench Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for SmarTemp® X1 appear to be based on demonstrating equivalence or meeting certain thresholds compared to the predicate device, Luxatemp® Ultra/Star, for critical physical properties.

Property	Acceptance Criteria (Predicate Device K101710)	Reported Device Performance (SmarTemp® X1)
Compressive Strength	>300 MPa	>300 MPa
Flexural Strength	>100 MPa	>100 MPa
Shrinkage	< 3%	< 3%
Water Sorption	≤ 40 µg/mm³	≤ 40 µg/mm³
Water Solubility	≤ 7.5 µg/mm³	≤ 7.5 µg/mm³
Intended Uses	Equivalent indications	Equivalent indications
Classification Product Code	EBG	EBG
Regulation Number	21 CFR 872.3770	21 CFR 872.3770
Principle of operation	Temporary crown and bridge resin	Temporary crown and bridge resin
Base/Catalyst Ratio	10:1	10:1
Self-curing	Yes	Yes
Radiopaque	Yes	Yes
Exhibits fluorescence	Yes	Yes
Chemical composition (dimethacrylate based)	dimethacrylate based composite resin	dimethacrylate based composite resin

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the bench performance tests (compressive strength, volumetric shrinkage, water sorption, water solubility). It refers to "testing was conducted on both SmarTemp® X1 and the predicate device."

The data provenance is from bench testing presumably conducted by Parkell, Inc. or a contracted lab. There is no information regarding country of origin or whether it's retrospective or prospective, as these are not typically relevant for bench testing of material properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. For material property testing like compressive strength, shrinkage, water sorption, and solubility, "ground truth" is established through standardized laboratory measurement methods as defined by relevant ISO standards (though specific standards for these properties are not detailed in the document, they are implied by the nature of the tests). Expert consensus from medical professionals is not used to establish these physical characteristics.

4. Adjudication Method for the Test Set

Not applicable. This concept (e.g., 2+1, 3+1) is relevant for clinical studies involving human interpretation or expert review of data. Bench testing of material properties typically involves direct measurements and adherence to specific test protocols for which adjudication methods are irrelevant.

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. This device is a dental material, not an AI/ML medical device. Therefore, no MRMC study or AI assistance was involved in its evaluation.

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

Not applicable. This is a dental material, not an AI algorithm.

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

The "ground truth" for the material properties tested (compressive strength, flexural strength, shrinkage, water sorption, water solubility) is established via direct physical and chemical measurements obtained through standardized laboratory testing methods. These are objective measurements rather than subjective expert consensus or clinical outcomes.

8. The Sample Size for the Training Set

Not applicable. This is a dental material, not an AI/ML device that requires a training set.

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

September 5, 2019

Parkell, Inc. David Mott Vice President- Legal, R&D, and Regulatory 300 Executive Drive Edgewood, New York 11717

Re: K190930

Trade/Device Name: SmarTemp X1 Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, POW Dated: June 5, 2019 Received: June 7, 2019

Dear David Mott:

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

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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 (OS) 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 mediation-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) K190930

Device Name SmarTemp® X1

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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1. Submitter

Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 Phone: 631-389-1545 dmott@parkell.com

Contact Person: David Mott, Vice President - Legal, R&D, and Regulatory Date of Original Submission: April 9, 2019 Date of Latest Revision: September 5, 2019

2. Device

Device Proprietary Name:	SmarTemp® X1
Common or Usual Name:	Temporary crown and bridge resin
Classification Name:	Temporary crown and bridge resin
Regulation Number:	21 CFR 872.3770
Product Code:	EBG
Device Classification	II

3. Predicate Device

Luxatemp® Ultra/Star, K101710, DMG USA, Inc.

4. Device Description

5. Indications for Use

SmarTemp® X1 is a self-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, onlays, long-term temporaries, and temporary veneers.

6. Comparison of Technological Characteristics

Information provided in this 510(k) submission demonstrates that SmarTemp® X1 is substantially

Image /page/3/Picture/17 description: The image shows the logo for DirectaDentalGroup. Below the main logo are the logos for DIRECTA, topdental, ORSING, and parkell. The logos are all white against a dark blue background. The DirectaDentalGroup logo is in a larger font than the other logos.

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Image /page/4/Picture/0 description: The image shows the logo for Parkell Inc. The word "parkell" is written in a bold, sans-serif font, with the letters closely spaced together. To the right of "parkell", the word "inc." is written in a smaller, cursive font. The logo is black and white.

equivalent to the Predicate Device (Luxatemp® Ultra/Star, K101710) in terms of critical properties for provisional materials, such as, for example, compressive strength, volumetric shrinkage, water sorption, and water solubility.

As is demonstrated throughout this submission and below in Table 5-A, any differences between the Device and the Predicate Device in the chemical make-up and/or physical properties, do not raise questions of substantial equivalence. Thus, this submission demonstrates the substantial equivalence between SmarTemp® X1 and the Predicate Device. A brief comparison of SmarTemp® X1 to the Predicate Device is provided below:

Property	SmarTemp® X1(Parkell, Inc.)	Predicate DeviceLuxatemp® Ultra/Star(K101710, DMG USA, Inc.)
Intended uses	SmarTemp® X1 is a self-curing composite for the fabrication of temporary crowns and bridges,inlays, onlays and veneers.SmarTemp® X1 is intended for the fabrication of:• temporary crowns• bridges• inlays• onlays• long-term temporaries• temporary veneers.	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 intended for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or partial denture.
Classification Product Code	EBG	EBG
Regulation Number	21 CFR 872.3770	21 CFR 872.3770
Principle of operation	Temporary crown and bridge resin	Temporary crown and bridge resin
Base/Catalyst Ratio	10:1	10:1
Self-curing	Yes	Yes
Radiopaque	Yes	Yes
Exhibits fluorescence	Yes	Yes
Compressive Strength(>300 MPa)	>300 MPa	>300 MPa
Flexural Strength(>100 MPa)	>100 MPa	>100 MPa

Table 5-A:

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Image /page/5/Picture/0 description: The image shows the logo for Parkell Inc. The logo is in black and white, with the word "parkell" in a bold, sans-serif font. The letters are all lowercase, and the "p" is slightly larger than the other letters. To the right of "parkell" is the word "inc." in a smaller, italicized font.

Table 5-A (continued):

Property	SmarTemp® X1(Parkell, Inc.)	Predicate DeviceLuxatemp® Ultra/Star(K101710, DMG USA, Inc.)
Shrinkage(< 3%)	< 3%	< 3%
Water Sorption(≤ 40 µg/mm³)	≤ 40 µg/mm³	≤ 40 µg/mm³
Water Solubility(≤ 7.5 µg/mm³)	≤ 7.5 µg/mm³	≤ 7.5 µg/mm³
Chemical composition	dimethacrylate basedcomposite resin, comprising fillercomponent(s)	dimethacrylate basedcomposite resin, comprising fillercomponent(s)

Non-clinical Performance Testing 7.

a. Biocompatibility

An evaluation of biocompatibility was conducted for SmarTemp® X1 in accordance with ISO 10993-1: 2009, ISO 10993-3: 2014, ISO 10993-5: 2009, ISO 10993-10: 2010, ISO 10993-11:2017, ISO 10993-12: 2012, ISO 10993-33: 2015, BS ISO 23317:2014, ISO/IEC 17025:2017, OECD 471, and the FDA's Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16, 2016).

b. Shelf life

Testing was conducted to evaluate the shelf life of SmarTemp® X1.

C. Bench Performance

Testing was conducted on both SmarTemp® X1 and the predicate device (Luxatemp® Ultra/Star, K101710) to evaluate critical properties including compressive strength, volumetric shrinkage, water sorption, and water solubility.

8. Clinical Performance Data

There was no clinical testing required to support the Device as the intended uses are equivalent to the Predicate Device. These types of devices have been on the market for many years with no reported adverse events. The non-clinical testing detailed in this submission supports the substantial equivalence of the Device.

9. Statement of Substantial Equivalence:

The information provided above supports that SmarTemp® X1 is substantially equivalent to the Predicate Device. Although minor differences in design and technology may exist between the subject and predicate devices, the testing supports that these differences do not raise any questions with respect to substantial equivalence. Therefore, it is concluded that SmarTemp® X1 is substantially equivalent to the Predicate Device.

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.