Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a material (thermoplastic resin) for fabricating dental prostheses and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

No
Explanation: The device is a material for fabricating dental prostheses, splints, and night guards, which are devices that replace missing teeth or protect existing ones, but do not inherently treat a disease or condition in a therapeutic manner. They provide support or correction.

Diagnostic

No
The device is described as a material (thermoplastic resin) used for fabricating dental prostheses and splints, not for diagnosing medical conditions. Its intended use is fabrication, not diagnosis.

SaMD (Software as a Medical Device)

No

The device is a physical material (thermoplastic resin) used for fabricating dental prostheses, not a software application.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for the fabrication of dental prostheses (dentures, splints, night guards). This is a manufacturing process for a medical device that is placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
Device Description: It's described as a thermoplastic material used for fabricating dental prostheses. This aligns with a material used in manufacturing, not a diagnostic test.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a biological sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition

Smiletone® is a medical device used in the fabrication of other medical devices (dental prostheses). It's classified as a material for dental use, not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Smiletone® (denture base resin) is a thermoplastic resin that is intended to be used in fabrication of removable full and partial dental prosthesis, as well as occlusal splints and night guards. The product is based on a compounded mixture of polyamide and pigments.

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

EBI

Device Description

Smiletone® is a thermoplastic material to be used for removable full or partial dental prosthesis. The product is based on a compounded mixture of Polyamide and pigments. Smiletone® is classified as 'Type 3-thermoplastic blank or powder' by EN ISO 20795-1[2013].

The expiry date (use-by date) is for 5 years from the date of manufacture.

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)

Biocompatibility and performance testing according to standard ISO 10993 Series and ISO 20795-1 were performed. All test results were satisfactory.

Dentistry - Medical devices for dentistry - Materials testing (EN 1641(2010)): Pass
Accelerate aging test (ASTM F1980(2002)): Pass
Visual Inspection (Performance test Guidance of dental materials (KFDA 2014)): Pass
Capacity test (Performance test Guidance of dental materials (KFDA 2014)): Pass
Packaging(Visual Inspection) test (Performance test Guidance of dental materials (KFDA 2014)): Pass
Surface characteristics test (EN ISO 20795-1): Pass
Shape characteristics test (EN ISO 20795-1): Pass
Color test (EN ISO 20795-1): Pass
Color Stability test (EN ISO 20795-1): Pass
Translucency test (EN ISO 20795-1): Pass
Freedom from porosity test (EN ISO 20795-1): Pass
Bonding to synthetic polymer teeth test (EN ISO 20795-1): Pass
Residual Monomer test (EN ISO 20795-1): Pass
Sorption test (EN ISO 20795-1): Pass
Solubility test (EN ISO 20795-1): Pass
Ultimate flexural strength test (EN ISO 20795-1): Pass
Genotoxicity test : BACTERIAL REVERSE MUTATION STUDY (AMES) (Under the conditions of ISO 10993-3, Tests for genotoxicity carcinogenicity and reproductive toxicity & OECD 471 Bacterial Reverse Mutation Test, the test articles should meet the test requirements.): Pass
Cytotoxicity Test (Agar diffusion test) (Under the conditions of ISO7405:2008, Evaluation of biocompatibility of medical devices used in dentistry, 6.2 Agar diffusion test, the test articles should meet the test requirements.): Pass
Acute Systemic Toxicity Test (Under the conditions of ISO 10993-11, 5. Acute Systemic Toxicity Test, the test articles should meet the test requirements.): Pass
Maximization Sensitization Test (LLNA-BrdU) (Under the conditions of ISO 10993-10, 7.2. Murine Local Lymph Node Assay (LLNA) & OECD 442B :2010, Skin Sensitization Local Lymph Node Assay : BrdU-ELISA, the test articles should meet the test requirements.): Pass
Oral mucosa irritation test (Under the conditions of ISO10993-10 : 2010, Test for Irritation and skin sensitization Annex B. Special irritation tests B.3 Oral mucosa irritation test, the test articles should meet the test requirements.): Pass

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.

K123220, K053060

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.

Not Found

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

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, abstract design above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 13, 2015

Korea Engineering Plastics Co., Ltd. c/o Mr. Charlie Mack Principal Engineer International Regulatory Consultants 12226 Washington Lane Parker, Arizona 85344

Re: K152270

Trade/Device Name: Smiletone® Regulation Number: 21 CFR 872.3690 Regulation Name: Denture Relining, Repairing, Rebasing Resin Regulatory Class: II Product Code: EBI Dated: August 31, 2015 Received: September 10, 2015

Dear Mr. Mack:

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. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

Indications for Use

510(k) Number (if known) K152270

Device Name Smiletone®

Indications for Use (Describe)

Smiletone® (denture base resin) is a thermoplastic resin that is intended to be used in fabrication of removable full and partial dental prosthesis, as well as occlusal splints and night guards. The product is based on a compounded mixture of polyamide and pigments.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 1, 2015

1. Company and Correspondent making the submission:
  Name - KOREA ENGINEERING PLASTICS Co., Ltd. Address – 216, 217, 218, B Bldg, 17, Gosan-ro 148 beon-gil, Gunpo-si, Gyeonggi-

do, 435-833, Korea

Phone : +82-31-689-3615

Fax : +82-31-8086-8285

Contact - Mrs. Song-yi Chong

Internet — http://www.kepital.com/

Primary contact and correspondent: Name: Charles Mack Address: 12226 Washington Lane, Parker, Arizona 85344 Phone" 931-625-4938 Email: charliemack@irc-us.com

1. Device :

Trade/proprietary name	: Smiletone®
Common Name	: Denture base resin
Classification Name	: Resin, Denture, Relining, Repairing, Rebasing

3. Predicate Device :

Manufacturer	: Vertex Dental B.V.
Device	: ThermoSens Rigid
510(k) Number	: K123220 (Decision Date - Dec. 3. 2010)

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Manufacturer	: Thermoplastic Comfort Systems, Inc.
Device	: TCS® Unbreakable
510(k) Number	: K053060 (Decision Date - Jul. 20. 2006)

1. Classifications Names & Citations :
  21CFR872.3760, EBI, Resin, Denture, Relining, Repairing, Rebasing, Class2
1. Description :
  Smiletone® is a thermoplastic material to be used for removable full or partial dental prosthesis. The product is based on a compounded mixture of Polyamide and pigments. Smiletone® is classified as 'Type 3-thermoplastic blank or powder' by EN ISO 20795-1[2013].

The expiry date (use-by date) is for 5 years from the date of manufacture.

1. Indication for use :
  Smiletone® (denture base resin) is a thermoplastic resin that is intended to be used in fabrication of removable full and partial dental prosthesis, as well as occlusal splints and night guards. The product is based on a compounded mixture of Polyamide and pigments.
1. Comparison with predicate device :
  KOREA ENGINEERING PLASTICS Co., Ltd., believes that the Smiletone® is substantially equivalent to the ThermoSens Rigid of Vertex Dental B.V. and TCS® Unbreakable of Thermoplastic Comfort Systems, Inc..

The Smiletone® described in this 510(k) has the same intended use and similar technical characteristics as the ThermoSens Rigid of Vertex Dental B.V. and TCS® Unbreakable of Thermoplastic Comfort Systems, Inc..

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| | Vertex
(ThermoSens Rigid)
Primary Predicate | Thermoplastic
Comfort Systems,
Inc.
Reference Predicate | KOREA
ENGINEERING
PLASTICS
(Smiltone) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No | K123220 | K053060 | - |
| Intended use | Vertex ThermoSens
Rigid is intended for
removable full and
partial dentures as
well as splints,
telescope
constructions and
temporary crown and
bridge constructions. | Fabrication and repair
of removable dental
prosthetic devices,
such as full and partial
dentures, orthodontic
devices, occlusal
splints, and night
guards. | Smiletone® is a
thermoplastic resin that
is intended to be used in
fabrication of removable
full and partial dental
prosthesis, as well as
occlusal splints and night
guards. |
| Biocompatibility | EN ISO 10993-3, 5,
10, 11 | EN ISO 10993-3, 5,
10, 11 | EN ISO 10993-3, 5, 10,
11 |
| Device
description | Vertex ThermoSens
Rigid is a
thermoplastic material
that is intended to be
used in the fabrication
of removable full and
partial dental
prostheses. The
product is based on a
compounded mixture
of Polyamide and
pigments. | TCS®
Unbreakable is a
break resistant
material used in the
fabrication and repair
of base plates for
removable dental
prosthetic appliances
where superior
flexibility and patient
comfort for the lifetime
of the prosthetic are
significant concerns.
This includes, but not
to be limited to, full
and partial dentures,
orthodontic devices,
occlusal splints, and
night guards. | Smiletone® is a
thermoplastic resin that
is intended to be used in
the fabrication of
removable full and partial
dental prostheses. The
product is based on a
compounded mixture of
Polyamide and pigments. |
| Composition of
Materials | Polyamide 12 | Polyamide 12 | Polyamide 12 |
| Physical
Properties | Flexural strength
: Not tested by
Sponsor
Impact Strength
: 8.0 ± 7.0 kJ/m²
Flexural modulus
: 1339 ± 54 MPa
Water absorption
: 31.2 ± 0.8 µg/mm²
Water solubility
: -0.20 ± 0.25 µg/mm² | Flexural strength
: Not tested by
Sponsor
Impact Strength
: 8.5 ± 1.2 kJ/m²
Flexural modulus
: 353 ± 4.24 MPa
Water absorption
: 14.6 ± 0.4 µg/mm²
Water solubility
: 2.5 ± 0.7 µg/mm² | Flexural strength
: 68 ± 2 MPa
Flexural modulus
: 1389 ± 35 MPa
Water absorption
: 30.7 ± 0.2 µg/mm²
Water solubility
: 0.33 ± 0.1 µg/mm² |
| Standards of
Conformity | ISO 20795-1 | EN ISO 20795-1 | EN ISO 20795-1 |

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8. Biocompatibility and Performance Data :

Biocompatibility and performance testing according to standard ISO 10993 Series and ISO 20795-1 were performed. All test results were satisfactory.

Title	Test Standard	Results
Dentistry - Medical
devices for dentistry -
Materials testing	EN 1641(2010)	Pass
Accelerate aging test	ASTM F1980(2002)	Pass
Visual Inspection	Performance test
Guidance of dental
materials (KFDA

                                                                                                                                                     | Pass    |

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1. Conclusions :
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification KOREA ENGINEERING PLASTICS Co., Ltd. concludes that The Smiletone® is substantially equivalent to predicate devices as described herein with reference to biocompatibility, Indications for use and performance data.
1. KOREA ENGINEERING PLASTICS Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END