Who is the manufacturer of Denture base resin?

Korea Engineering Plastics Co., Ltd. filed the 510(k) submission for Denture base resin (K152270).

What is the FDA product code for Denture base resin?

EBI. It is classified under 21 CFR 872.3760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Denture base resin?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Denture base resin?

ThermoSens Rigid (K123220); TCS® Unbreakable (K053060).

Who can help prepare an FDA 510(k) submission like Denture base resin?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Denture base resin

K152270 · Korea Engineering Plastics Co., Ltd. · EBI · Nov 13, 2015 · Dental

Device Facts

Record ID	K152270
Device Name	Denture base resin
Applicant	Korea Engineering Plastics Co., Ltd.
Product Code	EBI · Dental
Decision Date	Nov 13, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3760
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Smiletone® is a thermoplastic resin material composed of polyamide and pigments; used by dental professionals for the fabrication of removable full and partial dental prostheses, occlusal splints, and night guards. The device is supplied as a thermoplastic blank or powder (Type 3 per EN ISO 20795-1). It serves as a structural base material for dental appliances. Clinical benefit is derived from its use as a durable, biocompatible material for restorative dental applications. The device is processed in a dental laboratory setting to form the final prosthetic shape.

Clinical Evidence

Bench testing only. Performance evaluated against EN ISO 20795-1 standards, including flexural strength, water sorption/solubility, color stability, translucency, and bonding to synthetic teeth. Biocompatibility testing conducted per ISO 10993 series, including AMES test (genotoxicity), agar diffusion (cytotoxicity), acute systemic toxicity, LLNA-BrdU (sensitization), and oral mucosa irritation. All tests passed.

Technological Characteristics

Thermoplastic resin (Polyamide 12) supplied as blank or powder. Classified as Type 3 per EN ISO 20795-1. Physical properties: flexural strength 68 ± 2 MPa, flexural modulus 1389 ± 35 MPa. Conforms to EN ISO 20795-1 and ASTM F1980 (accelerated aging).

Indications for Use

Indicated for patients requiring removable full or partial dental prostheses, occlusal splints, or night guards.

Regulatory Classification

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.

Predicate Devices

ThermoSens Rigid (K123220)
TCS® Unbreakable (K053060)

Related Devices

K113608 — DEFLEX · Nuxen S.R.L. · Apr 10, 2012
K190790 — Flex Fit · Dk Mungyo Corporation · Jul 31, 2020
K061501 — FLEXO DENTAL RESIN MATERIAL · Aci, Inc. · Jul 26, 2006
K063626 — DURAFLEX · Cosmetic Dental Materials, Inc. · Feb 8, 2007
K992956 — LUCITONE FRS FLEXIBEL DENTAL RESIN · Dentsply Intl. · Oct 6, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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 - 2. 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) | {5}------------------------------------------------ | Manufacturer | : Thermoplastic Comfort Systems, Inc. | |---------------|-------------------------------------------| | Device | : TCS® Unbreakable | | 510(k) Number | : K053060 (Decision Date - Jul. 20. 2006) | - 4. Classifications Names & Citations : 21CFR872.3760, EBI, Resin, Denture, Relining, Repairing, Rebasing, Class2 - 5. 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. - 6. 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. - 7. 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.. {6}------------------------------------------------ | | 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 | {7}------------------------------------------------ # 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 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 | | Title | Test Standard | Results | | 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 | {8}------------------------------------------------ - 9. 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. - 10. KOREA ENGINEERING PLASTICS Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA. END