GLOSSY COAT (15ML)

K254091 · YAMAHACHI DENTAL MFG., Co. · EBD · Apr 6, 2026 · Dental

Device Facts

• Record ID: K254091
• Device Name: GLOSSY COAT (15ML)
• Applicant: YAMAHACHI DENTAL MFG., Co.
• Product Code: EBD · Dental
• Decision Date: Apr 6, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2

Indications for Use

GLOSSY COAT is indicated for use in the oral cavity or on a working model to coat the surface of resin-based dental prostheses (e.g., crowns, bridges, and dentures) in order to improve surface smoothness and wear resistance.

Device Story

Glossy Coat is a light-cured liquid coating material for resin-based dental prostheses; applied to crowns, bridges, and dentures to enhance surface smoothness and wear resistance. Used by dental professionals in clinical or laboratory settings. Applied to prosthesis surface and cured using an LED light source (365-410nm). Provides a uniform, glossy finish; serves as an alternative to conventional mechanical polishing. Benefits include improved surface properties and simplified finishing workflows.

Clinical Evidence

No clinical data. Evidence is based on bench testing, including hardness (Hv0.2) and viscosity (mPa·s) measurements compared to the predicate, and biocompatibility testing per ISO 10993-1:2025 (cytotoxicity, sensitization, irritation, systemic toxicity, local effects, genotoxicity, and carcinogenicity).

Technological Characteristics

Liquid light-cured coating material. Composition: Multi-functional acrylate, methylmethacrylate, silica filler, photo initiator. Curing: LED light source (365-410nm). Physical properties: Hardness (min 18Hv0.2), Viscosity (7-25 mPa·s). Biocompatibility: ISO 10993-1:2025 compliant for long-term mucosal contact.

Indications for Use

Indicated for patients requiring resin-based dental prostheses (crowns, bridges, dentures) to improve surface smoothness and wear resistance via application in the oral cavity or on a working model.

Regulatory Classification

Identification

A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Predicate Devices

• OPTIGLAZE COLOR (K133836)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 6, 2026

YAMAHACHI DENTAL MFG., Co.
Hirota Shuhei
Quality Control Section
54-1 Ochigara, Nishiura-Cho
Gamagori, Aichi 443-0105
JAPAN

Re: K254091
Trade/Device Name: Glossy Coat (15ml)
Regulation Number: 21 CFR 872.3310
Regulation Name: Coating Material For Resin Fillings
Regulatory Class: Class II
Product Code: EBD
Dated: March 10, 2026
Received: March 11, 2026

Dear Hirota Shuhei:

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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K254091 - Hirota Shuhei
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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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K254091 - Hirota Shuhei
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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, MChE, 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) K254091 | |
| Device Name GLOSSY COAT (15ML) | |
| Indications for Use (Describe) GLOSSY COAT is indicated for use in the oral cavity or on a working model to coat the surface of resin-based dental prostheses (e.g., crowns, bridges, and dentures) in order to improve surface smoothness and wear resistance. | |
| 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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YAMAHACHI DENTAL MFG., CO.
MANUFACTURERS, IMPORTERS AND
EXPORTERS OF DENTAL PRODUCTS
54-1 OCHIGARA, NISHIURA-CHO
GAMAGORI-CITY, AICHI-PREF., JAPAN 443-0105
TEL: [phone]
FAX: [phone]
URL: http://www.yamahachi-dental.co.jp/
E-mail: [e-mail]

# 510(k) Summary

Prepared on 2026.3.6

Contact details

| Applicant name | YAMAHACHI DENTAL MFG., Co. |
| --- | --- |
| Applicant Address | 54-1 Ochigara, Nishiura-Cho Gamagori Aichi-Pref
443-0105 Japan |
| Applicant Contact Telephone | [phone] |
| Applicant Contact | Shuhei Hirota |
| Applicant Contact Email | [e-mail] |

Device name

| | Trade Name | Model |
| --- | --- | --- |
| Device Trade Name | GLOSSY COAT | 15ML |

Common Name: Coating material for resin fillings

Classification Name: COATING, FILLING MATERIAL, RESIN

Regulation Number: 872.3310

Product Code: EBD

Legally Marketed Predicate Device

| Predicate # | Predicate Trade Name | Product Code |
| --- | --- | --- |
| K133836 | OPTIGLAZE COLOR | EBD |

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YAMAHACHI

YAMAHACHI DENTAL MFG, CO,

MANUFACTURERS, IMPORTERS AND

EXPORTERS OF DENTAL PRODUCTS

54-1 OCHIGARA, NISHIURA-CHO

GAMAGORI-CITY, AICHI-PREF., JAPAN 443-0105

TEL: ++81-533-57-7121

FAX: ++81-533-57-1764

URL: http://www.yamahachi-dental.co.jp/

E-mail: [e-mail]

# 1. Device Description Summary

GLOSSY COAT is coating material. The coating material is applied to resin-based dental prostheses (e.g. crowns, bridges, and dentures) and light-cured, making it easier to achieve a glossy finish than with conventional polishing.

# 2. Indications for Use

GLOSSY COAT is indicated for use in the oral cavity or on a working model to coat the surface of resin-based dental prostheses (e.g., crowns, bridges, and dentures) in order to improve surface smoothness and wear resistance.

# 3. Technological Comparison

| | Subject Device | Predicate Device | Differences | |
| --- | --- | --- | --- | --- |
| Device Name | GLOSSY COAT | OPTIGLAZE COLOR | | |
| Company | Yamahachi Dental | GC AMERICA INC. | | |
| Classification & Product Code | 872.3310; EBD | 872.3310; EBD | Same | |
| Device Description | A light-cured, surface gloss coating material for restorations. | A light cured glazing and characterizing material for such restorations as direct and indirect composite resins & acrylics | Similar | The intended use of GLOSSY COAT is included in the intended use of OPTIGLAZE COLOR. |
| Intended Use | Apply to resin-based dental prostheses (e.g. crowns, bridges, dentures) to enhance smoothness and wear resistance | For characterization of restorations made of composite resins & acrylics. For obtaining surface smoothness and wear resistance of made of composite resins & acrylics. | Similar | The intended use of GLOSSY COAT is included in the intended use of OPTIGLAZE COLOR. |
| Product State | Liquid | Liquid | Same | |
| Recommended Curing Light Unit | LED light source Chairside LED light source | LED Light, Halogen light, Plasma Arc | Similar | Both are cured by LED light. |
| Effective Wavelength | 365~410nm | Lower than 430nm (LED light source) | Similar | Both are cured by visible light. |

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YAMAHAACH

YAMAHACHI DENTAL MFG, CO,

MANUFACTURERS, IMPORTERS AND

EXPORTERS OF DENTAL PRODUCTS

54-1 OCHIGARA, NISHIURA-CHO

GAMAGORI-CITY, AICHI-PREF., JAPAN 443-0105

TEL:++81-533-57-7121

FAX:++81-533-57-1764

URL:http://www.yamahachi-dental.co.jp/

E-mail:[e-mail]

| Curing Time | 3 min (LED light source)
20Sec (Chairside LED light source) | 90 sec (GC LABOLIGHT DUO)
5 min (GC LABOLIGHT LV-III,II)
10~20 sec(GC STEPLIGHT SL-I)
40 sec (Halogen Light)
8 sec (Plasma Arc)
40 sec(LED Light (wavelength 400~430nm)) | Similar | This varies greatly depending on the type of photopolymerization device. |
| --- | --- | --- | --- | --- |
| Components | Multi-functional acrylate, Methylmethacrylate, Silica filler, Photo initiator, others | Multifunctional acrylate, Methyl methacrylate, Silica filler, Photo initiator, Pigment | Similar | The main ingredients are the same. Since it is a product of another company, it is not possible to know whether it is made of exactly the same materials. |
| Appearance | The cured coating surface is uniform and free of impurities | The cured coating surface is uniform and free of impurities | Similar | These are within specification (in-house standard). Therefore, the physical properties of these products are similar. |
| Hardness (Hv0.2)
(Min: 18Hv0.2) | Above standard value | Above standard value | Similar | |
| Coating properties | Good | Good | Similar | |
| Viscosity (mPa · s)
(If it is between 7 and 25, there will be no problems with operability.) | Within standard value | Within standard value | Similar | |

# 4. Non-Clinical and/or Clinical Tests Summary & Conclusions

The hardness and viscosity of the target device and the predicate device are equivalent, and both meet the company's internal standards.

# 5. Substantial Equivalence Summary / Conclusion

In summary, GLOSSY COAT has the same intended use as the equivalent product. The method to fabricate the final product and the physical properties are also almost the same as the equivalent product. The equivalent product is a product of another company, so the detailed ingredients are unknown, but the main ingredients are also the same as the equivalent product. In conclusion, GLOSSY COAT has been proven to be legally substantially equivalent to the commercially available device OPTIGLAZE COLOR (K133836) and has received appropriate approval for pre-marketing activities in the United States.

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YAMAHACHI DENTAL MFG, CO, MANUFACTURERS, IMPORTERS AND EXPORTERS OF DENTAL PRODUCTS

54-1 OCHIGARA, NISHIURA-CHO
GAMAGORI-CITY, AICHI-PREF., JAPAN 443-0105
TEL: [phone]
FAX: [phone]
URL: http://www.yamahachi-dental.co.jp/
E-mail: [e-mail]

## 6. Test of Biocompatibility Summary & Conclusions

The category and contact parts of GLOSSY COAT are as follows according to ISO 10993-1:2025.

Category: Surface device

Contact parts: Mucosal membrane (oral cavity) Duration: Long term (more than 30 days)

The product was evaluated for the following items in accordance with ISO 10993-1:2025 and demonstrated its biological safety.

- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Local effects
- Genotoxicity
- Carcinogenicity