(94 days)
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.
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 provided document describes the 510(k) premarket notification for the Smiletone® denture base resin, not a device with AI or machine learning components. Therefore, many of the requested categories related to AI/ML device studies (such as multi-reader multi-case studies, effect size of AI assistance, expert qualifications for ground truth, adjudication methods, and training/test set sample sizes for algorithms) are not applicable.
However, the document does contain information about performance testing and acceptance criteria for the material.
Here's a summary of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" with numerical thresholds against which the device performance is reported. Instead, it states that "All test results were satisfactory" and indicates "Pass" for each test against various standards. The acceptance criteria are implied to be meeting the requirements of the specified standards (e.g., EN ISO 20795-1, ISO 10993 series).
| Test Title | Test Standard | Reported Device Performance (Acceptance Criteria Implicitly Met) |
|---|---|---|
| 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) | ISO 10993-3 & OECD 471 Bacterial Reverse Mutation Test | Pass |
| Cytotoxicity Test (Agar diffusion test) | ISO7405:2008 | Pass |
| Acute Systemic Toxicity Test | ISO 10993-11 | Pass |
| Maximization Sensitization Test (LLNA-BrdU) | ISO 10993-10 & OECD 442B:2010 | Pass |
| Oral mucosa irritation test | ISO10993-10:2010 Annex B.3 | Pass |
Note on Physical Properties (Specific Values from Predicate Comparison):
While not explicitly stated as "acceptance criteria" for Smiletone, the comparison table ([6]) provides specific physical property values for Smiletone and its predicates. For Smiletone:
- 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
These values would implicitly need to meet certain ranges or be comparable to the predicates as part of the overall demonstration of substantial equivalence.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each of the physical, chemical, and biological tests. It states that tests were performed according to standards (e.g., ISO, ASTM, OECD, KFDA guidance), which typically include requirements for sample size and testing methodology.
The data provenance is not explicitly stated in terms of country of origin of the data, but the testing appears to have been conducted based on international standards (ISO, ASTM, OECD) and a Korean FDA (KFDA) guidance, suggesting either international or Korean testing laboratories. The KFDA guidance implies the reporting entity and potentially the data origin is from Korea. The tests are prospective in the sense that they were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material testing study, not an AI/ML device requiring clinical expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. This is a material testing study.
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 is a material testing study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material testing study.
7. The type of ground truth used
The "ground truth" for the material testing is based on objective measurements and compliance with established international and national standards for denture base resins (e.g., EN ISO 20795-1 for physical properties, ISO 10993 series and OECD guidelines for biocompatibility). The results are quantitative measurements or qualitative observations (e.g., visual inspection) evaluated against predefined specifications within the standards.
8. The sample size for the training set
Not applicable. This is a material testing study, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a material testing study.
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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
-
- 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-
- Company and Correspondent making the submission:
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
-
- 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) |
-
- Classifications Names & Citations :
21CFR872.3760, EBI, Resin, Denture, Relining, Repairing, Rebasing, Class2
- Classifications Names & Citations :
-
- 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].
- Description :
The expiry date (use-by date) is for 5 years from the date of manufacture.
-
- 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.
- Indication for use :
-
- 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..
- Comparison with predicate device :
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 | ThermoplasticComfort Systems,Inc.Reference Predicate | KOREAENGINEERINGPLASTICS(Smiltone) | |
|---|---|---|---|
| 510(k) No | K123220 | K053060 | - |
| Intended use | Vertex ThermoSensRigid is intended forremovable full andpartial dentures aswell as splints,telescopeconstructions andtemporary crown andbridge constructions. | Fabrication and repairof removable dentalprosthetic devices,such as full and partialdentures, orthodonticdevices, occlusalsplints, and nightguards. | Smiletone® is athermoplastic resin thatis intended to be used infabrication of removablefull and partial dentalprosthesis, as well asocclusal splints and nightguards. |
| Biocompatibility | EN ISO 10993-3, 5,10, 11 | EN ISO 10993-3, 5,10, 11 | EN ISO 10993-3, 5, 10,11 |
| Devicedescription | Vertex ThermoSensRigid is athermoplastic materialthat is intended to beused in the fabricationof removable full andpartial dentalprostheses. Theproduct is based on acompounded mixtureof Polyamide andpigments. | TCS®Unbreakable is abreak resistantmaterial used in thefabrication and repairof base plates forremovable dentalprosthetic applianceswhere superiorflexibility and patientcomfort for the lifetimeof the prosthetic aresignificant concerns.This includes, but notto be limited to, fulland partial dentures,orthodontic devices,occlusal splints, andnight guards. | Smiletone® is athermoplastic resin thatis intended to be used inthe fabrication ofremovable full and partialdental prostheses. Theproduct is based on acompounded mixture ofPolyamide and pigments. |
| Composition ofMaterials | Polyamide 12 | Polyamide 12 | Polyamide 12 |
| PhysicalProperties | Flexural strength: Not tested bySponsorImpact Strength: 8.0 ± 7.0 kJ/m²Flexural modulus: 1339 ± 54 MPaWater absorption: 31.2 ± 0.8 µg/mm²Water solubility: -0.20 ± 0.25 µg/mm² | Flexural strength: Not tested bySponsorImpact Strength: 8.5 ± 1.2 kJ/m²Flexural modulus: 353 ± 4.24 MPaWater absorption: 14.6 ± 0.4 µg/mm²Water solubility: 2.5 ± 0.7 µg/mm² | Flexural strength: 68 ± 2 MPaFlexural modulus: 1389 ± 35 MPaWater absorption: 30.7 ± 0.2 µg/mm²Water solubility: 0.33 ± 0.1 µg/mm² |
| Standards ofConformity | 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 - Medicaldevices for dentistry -Materials testing | EN 1641(2010) | Pass |
| Accelerate aging test | ASTM F1980(2002) | Pass |
| Visual Inspection | Performance testGuidance of dentalmaterials (KFDA2014) | Pass |
| Capacity test | Performance testGuidance of dentalmaterials (KFDA2014) | Pass |
| Packaging(VisualInspection) test | Performance testGuidance of dentalmaterials (KFDA2014) | Pass |
| Surface characteristicstest | EN ISO 20795-1 | Pass |
| Shape characteristicstest | 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 porositytest | EN ISO 20795-1 | Pass |
| Bonding to syntheticpolymer 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 strengthtest | EN ISO 20795-1 | Pass |
| Title | Test Standard | Results |
| Genotoxicity test :BACTERIAL REVERSEMUTATION STUDY(AMES) | Under the conditions of ISO 10993-3, Tests forgenotoxicity carcinogenicity and reproductivetoxicity & OECD 471 Bacterial Reverse MutationTest, the test articles should meet the testrequirements. | Pass |
| Cytotoxicity Test (Agardiffusion test) | Under the conditions of ISO7405:2008,Evaluation of biocompatibility of medical devicesused in dentistry, 6.2 Agar diffusion test, the testarticles should meet the test requirements. | Pass |
| Acute Systemic ToxicityTest | Under the conditions of ISO 10993-11, 5. AcuteSystemic Toxicity Test, the test articles shouldmeet the test requirements. | Pass |
| Maximization SensitizationTest (LLNA-BrdU) | Under the conditions of ISO 10993-10, 7.2.Murine Local Lymph Node Assay (LLNA) &OECD 442B :2010, Skin Sensitization LocalLymph Node Assay : BrdU-ELISA, the testarticles 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 irritationtest, the test articles should meet the testrequirements. | Pass |
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-
- 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.
- Conclusions :
-
- KOREA ENGINEERING PLASTICS Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- KOREA ENGINEERING PLASTICS Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
§ 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.