(148 days)
Not Found
No
The device description and performance studies focus on the material properties of a self-curing composite, with no mention of AI or ML technologies.
No
The device is a material used for fabricating temporary dental restorations, not a device that directly provides therapy or treatment to a patient.
No
SmarTemp® X1 is a material used for fabricating temporary dental restorations, not for diagnosing medical conditions. The "Indications for Use" and "Device Description" sections clearly state its purpose is for creating temporary crowns, bridges, inlays, etc.
No
The device description clearly states that SmarTemp® X1 is a self-curing, resin-based composite material, which is a physical substance, not software.
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 SmarTemp® X1 is for the fabrication of temporary dental restorations (crowns, bridges, inlays, veneers). This is a direct application within the patient's mouth or for creating devices that will be placed in the mouth.
- Device Description: The description details a self-curing composite material used for creating physical dental prosthetics.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. SmarTemp® X1 is a material used in or for the body to create a physical structure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EBG, POW
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.
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)
Non-clinical Performance Testing was conducted.
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).
Shelf life: Testing was conducted to evaluate the shelf life of SmarTemp® X1.
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.
Key results from bench performance are listed in "Key Metrics".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Compressive Strength: >300 MPa
Flexural Strength: >100 MPa
Shrinkage:
§ 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.
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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
1
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)
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.
| 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
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.
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 Device
Luxatemp® 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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Table 5-A (continued):
| Property | SmarTemp® X1
(Parkell, Inc.) | Predicate Device
Luxatemp® Ultra/Star
(K101710, DMG USA, Inc.) |
|------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Shrinkage
(