DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)

K252035 · Kamemizu Chemical Industry Co., Ltd. · EBI · Sep 17, 2025 · Dental

Device Facts

• Record ID: K252035
• Device Name: DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)
• Applicant: Kamemizu Chemical Industry Co., Ltd.
• Product Code: EBI · Dental
• Decision Date: Sep 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

It is a soft acrylic resin used to line the denture base. It is a tissue conditioner. By lining the mucous membrane side of dentures, it is used for temporary relining, tissue conditioning, and obtaining functional impressions.

Device Story

DENTURE SOFT EX is a soft acrylic resin tissue conditioner for removable dentures; consists of powder (poly(ethyl methacrylate)) and liquid (plasticizer, ethanol); components mixed by clinician to initiate gelation; applied to mucous membrane side of denture base; used for temporary relining, tissue conditioning, and functional impressions; provides soft interface between denture and oral tissue; improves patient comfort during healing or adjustment periods.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 10139-1:2018 standards. Results confirm subject device performance is equivalent to the predicate device.

Technological Characteristics

Soft acrylic resin; powder (poly(ethyl methacrylate)) and liquid (plasticizer, ethanol) components; gelation via liquid permeation of powder; conforms to ISO 10139-1:2018.

Indications for Use

Indicated for patients requiring temporary denture relining, tissue conditioning, or functional impressions using a soft acrylic resin lining on the denture base.

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

• COE COMFORT (K070698)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

September 17, 2025

Kamemizu Chemical Industry Co., Ltd
Tomohiro Kinoshita
Quality Assurance Manager
17-16
Toyosato
Neyagawa, 5720071
JAPAN

Re: K252035

Trade/Device Name: DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)

Regulation Number: 21 CFR 872.3760
Regulation Name: Denture Relining, Repairing, Or Rebasing Resin
Regulatory Class: Class II
Product Code: EBI
Dated: June 30, 2025
Received: September 5, 2025

Dear Tomohiro Kinoshita:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252035 - Tomohiro Kinoshita
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252035 - Tomohiro Kinoshita
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

MICHAEL E. ADJODHA -S

Michael E. Adjodha, M.ChE., RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT 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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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252035 | |
| Device Name DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | |
| Indications for Use (Describe) It is a soft acrylic resin used to line the denture base. It is a tissue conditioner. By lining the mucous membrane side of dentures, it is used for temporary relining, tissue conditioning, and obtaining functional impressions. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| 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 [e-mail] | |
| "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." | |

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| 510(k) #: K252035 | 510(k) Summary | Prepared on: 2025-09-05 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | KAMEMIZU CHEMICAL INDUSTRY CO., LTD | |
| Applicant Address | 17-16 Toyosato Neyagawa 5720071 Japan | |
| Applicant Contact Telephone | [phone] | |
| Applicant Contact | Mr. Tomohiro Kinoshita | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | DENTURE SOFT EX (Pink set);
DENTURE SOFT EX (White set);
DENTURE SOFT EX (Pink powder);
DENTURE SPFT EX (White powder);
DENTURE SOFT EX (Liquid);
DENTURE SOFT EX (Trial kit Pink);
DENTURE SOFT EX (Trial kit White) | |
| Common Name | Denture relining, repairing, or rebasing resin | |
| Classification Name | Resin, Denture, Relining, Repairing, Rebasing | |
| Regulation Number | 872.3760 | |
| Product Code(s) | EBI | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K070698 | COE COMFORT | EBI |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| DENTURE SOFT EX is a soft lining material for removable dentures.
It is a soft acrylic resin used to line the denture base. It is a tissue conditioner. By lining the mucous membrane side of dentures, it is used for temporary relining, tissue conditioning, and obtaining functional impressions.
The device consists of powder and liquid. The powder contains acrylic polymer (POLY (ETHYL METHACRYLATE)) and others. The liquid contains plasticizer, ethanol and others.
The powder and liquid are mixed when it is used and starts gelation, forms soft acrylic resin. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| It is a soft acrylic resin used to line the denture base. It is a tissue conditioner. By lining the mucous membrane side of dentures, it is used for temporary relining, tissue conditioning, and obtaining functional impressions. | | |
| Indications for Use Comparison | | 21 CFR 807.92(a)(5) |

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It is the same. Indications for use of the predicate device includes that of the subject device.

| Technological Comparison | 21 CFR 807.92(a)(6) |
| --- | --- |
| The predicate device consists of the powder (mainly poly (ethyl methacrylate) and the liquid (mainly plasticizer (benzyl benzoate) and ethanol). Mixing the powder and liquid causes the liquid to permeate the powder, starting gelation and form soft acrylic resin. The subject device uses the same composition and technical characteristics. | |
| Non-Clinical and/or Clinical Tests Summary & Conclusions | 21 CFR 807.92(b) |
| Bench testing was done in accordance with ISO 10139-1:2018.
The subject device has performance meeting ISO 10139-1:2018.
The subject device and the predicate device have the same performance. It means the subject device is as safe, as effective, and performs as well as predicate device. | |