Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

K233954 · B&E Korea Co., Ltd. · ELW · Feb 13, 2024 · Dental

Device Facts

• Record ID: K233954
• Device Name: Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
• Applicant: B&E Korea Co., Ltd.
• Product Code: ELW · Dental
• Decision Date: Feb 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Chemi-SiL (HB, MB, LB, LBS) - Crown and bridge impression, inlay and onlay impressions Chemi-SiL Bite-Blu - Impression of the occlusal surface

Device Story

Chemi-SiL is a hydrophilic, addition-type polyvinylsiloxane (PVS) elastomeric impression material. It is supplied as a two-part base and catalyst system in 50 mL cartridges. The device is used by dental professionals to capture precise impressions of teeth, gingiva, or occlusal surfaces. The material is self-curing upon mixing. It is a single-patient, single-use, non-sterile device. The clinician uses the resulting impression to create dental models for restorative procedures like crowns, bridges, inlays, and onlays. The material's physical properties, such as consistency, working time, and dimensional stability, ensure accurate reproduction of oral structures, facilitating the fabrication of well-fitting dental restorations.

Clinical Evidence

No clinical data. Bench testing only. Testing included ISO 4823 (appearance, consistency, working/setting time, detail reproduction, gypsum compatibility, dimensional change, elastic recovery, strain in compression) and ISO 10993 (cytotoxicity, skin sensitization, oral mucosa irritation, acute systemic toxicity). All results met preset criteria.

Technological Characteristics

Addition-type polyvinylsiloxane (PVS) elastomeric impression material. Components: poly(dimethylsiloxane), vinyl-terminated siloxanes, methyl hydrogen polysiloxanes, synthetic amorphous silica, hydrophilic fumed silica, platinum complex catalyst, pigments, and surfactant. Supplied in 50 mL dual-cartridge systems. Self-curing. Conforms to ISO 4823 and DIN 13903 standards.

Indications for Use

Indicated for dental impression procedures, specifically crown and bridge, inlay, and onlay impressions (Chemi-SiL HB, MB, LB, LBS) and occlusal surface impressions (Chemi-SiL Bite-Blu).

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Vonflex STM (K152615)
• Hysil Impression Materials HySil Bite (K170736)

Submission Summary (Full Text)

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February 13, 2024

B&E Korea Co., Ltd. Jayong Shin RA Representative 995-16. Baran-ro. Jeongnam-myeon Hwaseong-si, Gyeonggi-do 18515 SOUTH KOREA

Re: K233954

Trade/Device Name: Chemi-SiL (HB, MB, LB, LBS) and Chemi-SiL Bite-Blu Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: December 15, 2023 Received: December 15, 2023

Dear Jayong Shin:

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.

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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 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-reportingcombination-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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).

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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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## Indications for Use

Submission Number (if known)

K233954

Device Name

Chemi-SiL (HB, MB, LB, LBS) Chemi-SiL Bite-Blu

Indications for Use (Describe)

Chemi-SiL (HB, MB, LB, LBS) - Crown and bridge impression, inlay and onlay impressions

Chemi-SiL Bite-Blu

- Impression of the occlusal surface
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)

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## K233954 510(k) SUMMARY

Date: Dec 15, 2023

### 1. SUBMITTER

B&E KOREA Co., Ltd. 995-16, Baran-ro, Jeongnam-myeon, Hwaseong-si, Gyeonggi-do, Republic of Korea TEL : [phone] FAX : [phone] Contact Name: Shin Jayong Email: [e-mail]

## 2. DEVICE

·Trade Name: Chemi-SiL (HB, MB, LB, LBS), Chemi-SiL Bite-Blu

·Common Name: Impression Material

·Classification Name: Material, Impression

·Regulation Number: 872.3660

·Class: 2

·Classification Product Code: ELW

## 3. PREDICATE DEVICE

Chemi-SiL (HB, MB, LB, LBS) Vonflex STM, K152615

Vericom Co. Ltd

Chemi-SiL Bite-Blu

K170736 Hysil Impression Materials HySil Bite, OSSTEM Implant Co., Ltd.

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### 4. DEVICE DESCRIPTION

Chemi-SiL of silicone impression materials are hydrophilic impression materials based on polyvinylsiloxane and it is used for impression of teeth or gingiva. It consists of three different consistencies (heavy body, light body, bite registration material) according to ISO 4823. And it is supplied base and catalyst in contrasting color. Each product is consisted of 1:1 base and catalyst component, packaged in two 50 mL catridges.

#### 5. INDICATIONS FOR USE

Chemi-SiL (HB, MB, LB, LBS)

- · Crown and bridge impression, inlay and onlay impressions
Chemi-SiL Bite-Blu

- Impression of the occlusal surface
#### 6. NON-CLINICAL TESTING

The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.

- ISO 4823 Appearance and Component colors, Consistency, Working time, Detail reproduction, Setting time, Compatibility with gypsum, Linear dimensional change, Elastic recovery, Strain in compression
- ISO 7405 Cytotoxicity .
- ISO 10993-10 - Skin sensitization, Oral mucosa irritation
- ISO 10993-11 - Acute systemic toxicity

### 7. SUBSTANITAL EQUIVALENCE

| Subject device | Predicate Device | Discuss/Justify the Differences | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| 510(k) Number | New | K152615 | - |
| Trade Name | Chemi-SiL (HB, MB, LB,<br>LBS) | Vonflex STM | - |
| Manufacturer | B&E KOREA Co., Ltd. | Vericom Co. Ltd | - |
| Common Name | Impression material | Impression material | Same |
| Device Class | 2 | 2 | Same |
| Product Code | ELW | ELW | Same |
| Indications for use | • Crown and bridge<br>impression, inlay and onlay<br>impressions | • Impression material in dual<br>phase impression technique<br>• Precise duplication of models<br>• Capturing multiple unit<br>impressions<br>• Impression of inlay, crown,<br>bridge and partial denture etc. | Same<br>The subject and<br>predicate device<br>have the same<br>intended use. Both<br>devices are used for<br>dental impression<br>techniques according<br>to their consistencies. |
| Physical State | Two product lines are provided<br>with different viscosity. (Heavy<br>body, Light body) | Various pastes with various<br>viscosity | Similar<br>Both subject and<br>predicate devices are<br>provided as putties<br>with various<br>elasticities.<br>The physical states<br>are similar, as<br>compared in physical<br>properties. |
| Structure | Addition type silicone based<br>elastomeric impression<br>materials | Addition type silicone based<br>elastomeric impression<br>materials | Same |
| Packaging | Primary packaging: Cartridges<br>Secondary packaging: Carton<br>box | Primary packaging: Cartridges<br>Secondary packaging: Carton<br>box | Same |
| Usage | Single patient, single use.<br>Not reusable | Single patient, single use.<br>Not reusable | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Handling System | Two part base/catalyst system | Two part base/catalyst system | Same |
| Type of Curing | Self-curing after mixing of base and catalyst part. | Self-curing after mixing of base and catalyst part. | Same |
| Physical properties | See the table below | See the table below | Similar<br>Individual values of<br>physical properties<br>are same or similar.<br>Every physical<br>property of predicate<br>and subject device<br>conforms to the<br>related standard. |
| Chemical composition | Poly(dimethylsiloxane), vinyl<br>terminated<br>Siloxanes and Silicones, di-ME,<br>ME Hydrogen, Hydrogen-<br>terminated Methyl hydrogen<br>polysiloxanes<br>Synthetic amorphous Silica<br>Hydrophilic Fumed Silica<br>Platinum complex<br>(3 % Pt by weight)<br>Pigments<br>surfactant | Vinyl siloxanes<br>Hydrogen polysiloxane<br>Silica<br>Fumed silica<br>Organo platinum complex<br>Pigments<br>Surfactant | Similar<br>Both device are<br>composed of vinyl<br>terminated siloxane,<br>cross-linking<br>siloxane, Filler,<br>platinum catalyst,<br>pigments and<br>surfactant. |
| Biocompatibility | Meets ISO 10993-1 for a<br>surface device contacting<br>mucosal membrane and dentin<br>for a short-term contact<br>duration (>24h) | Conforms with ISO 10993-1 | Same |
| Standards conformed | ISO 4823<br>ISO 10993-1 | ISO 4823<br>ISO 10993-1 | Same |

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Physical properties

| - | Chemi-SiL (HB, MB, LB, LBS) | Vonflex STM | Standard | Discuss/Justify the | |
|------------------------------------------------------|-----------------------------|---------------------------|--------------------------------|------------------------------------------------------------------------|---------------------------------------------|
| | | | | | |
| | | | | | Differences |
| Working time | MB | 90 s | 2'15"(Heavy,<br>normal) | [ISO<br>4823:2021<br>7.3]<br>suggested<br>value of the<br>manufacturer | Equivalent |
| | HB | | 1'30"(Heavy,<br>Fast) | | |
| | LB | 90 s | 2'30"(Light,<br>normal) | | Equivalent |
| | LBS | | 1'30"(Light,<br>Fast) | | |
| Setting reaction time | MB | 210 s | 4'00" (Heavy,<br>normal) | - | Equivalent |
| | HB | | 2'30" (Heavy,<br>Fast) | | |
| | LB | 210 s | 4'00"(Light,<br>normal) | | Equivalent |
| | LBS | | 2'30"(Light,<br>Fast) | | |
| Consistency | MB | 32.75 mm | 34.76 mm<br>(Heavy,<br>normal) | [ISO<br>4823:2021<br>7.2] | Equivalent |
| | HB | | 34.78 mm<br>(Heavy, Fast) | <= 35 mm | |
| | LB | 48.83 mm | 43.43 mm<br>(Light, normal) | [ISO<br>4823:2021<br>7.2] | Equivalent |
| | LBS | | 42.02 mm<br>(Light, Fast) | > =36 mm | |
| Compatibility with<br>gypsum | MB | Reproduced for<br>0.05 mm | Reproduced for<br>0.05 mm | [ISO<br>4823:2021<br>7.6] | Equivalent |
| | HB | | | 50 µm should<br>be reproduced<br>without<br>interruption. | |
| | LB | Reproduced for<br>0.05 mm | Reproduced for<br>0.05 mm | | Equivalent |
| | LBS | | | | |
| Strain in<br>compression (Curve<br>of the shrinkage) | MB | 1.2 % | 2.56 % (Heavy,<br>normal) | [ISO 4823:<br>2021 7.8]<br>it should be<br>within<br>0.8~20 % | Similar<br>Both conforms<br>to the standard |
| | HB | | 2.38 % (Heavy,<br>Fast) | | |
| | LB | 3.1 % | 7.71 % (Light,<br>normal) | [ISO 4823:<br>2021 7.8]<br>within<br>2.0~20 % | Similar<br>Both conforms<br>to the standard |
| | LBS | | 5.24 % (Light,<br>Fast) | | |
| Linear Dimensional<br>Change | MB | 0.12 % | 0.11 % (Heavy,<br>normal) | [ISO<br>4823:2021<br>7.5]<br><= 1.5 % | Similar<br>Both conforms<br>to the standard |
| | HB | | 0.07 % (Heavy,<br>Fast) | | |
| | LB | 0.04 % | 0.08 % (Light,<br>normal) | | Similar<br>Both conforms<br>to the standard |
| | LBS | | 0.09 % (Light,<br>Fast) | | |

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510(k) Summary of Vonflex STM is provided in Appendix A_K152615

| | Subject device | Predicate Device | Discuss/Justify the<br>Differences | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 510(k) Number | New | K170736 | - | |
| Trade Name | Chemi-SiL Bite-Blu | Hysil Impression Materials<br>HySil Bite | - | |
| Manufacturer | B&E KOREA Co., Ltd. | OSSTEM Implant Co., Ltd. | - | |
| Common Name | Impression material | Impression material | Same | |
| Device Class | 2 | 2 | Same | |
| Product Code | ELW | ELW | Same | |
| Indications for use | • Impression of the occlusal<br>surface | HySil Bite is used for<br>impression as below.<br>- Taking occlusal surfaces<br>- Confirming occlusal surfaces<br>- Recording after putting the | Same | |
| | | | articulator | |
| | Physical State | Bite registration materials | Bite registration materials | Same |
| Structure | | Addition type silicone based<br>elastomeric impression<br>materials | Addition type silicone based<br>elastomeric impression<br>materials | Same |
| | Packaging | Primary packaging: Cartridge<br>Secondary packaging: Carton<br>box | Primary packaging: Cartridge<br>Secondary packaging: Carton<br>box | Same |
| Usage | | Single patient, single use.<br>Not reusable | Single patient, single use.<br>Not reusable | Same |
| | Sterility | Non-sterile | Non-sterile | Same |
| | Handling System | Two part base/catalyst system | Two part base/catalyst system | Same |
| | Type of Curing | Self-curing after Hand-<br>kneaded mixes | Self-curing after Hand-<br>kneaded mixes | Same |
| Physical properties | Colours | Pass | Pass | Same<br>The classification of<br>the subject and<br>predicate device is<br>complied with DIN<br>13903 |
| | Working time | 55 s | Pass | |
| | Minimum<br>period spent in<br>the mouth | 95 s | 1 min. 30 sec | |
| | Recovery after<br>Deformation | 0.0 mm | more than 0.1 mm | |
| | Load<br>endurance<br>during<br>bending(Flexu<br>ral strength) | 8.2 N(20 s) | Pass | |
| | Hardness<br>degree(HD) | 50 HD | 50 HD | |
| | Linear<br>dimensional<br>change | 0.3 % | -0.16 % | |
| Chemical<br>composition | Poly(dimethylsiloxane), vinyl<br>terminated | Vinylpolysiloxane | Similar | |
| | Hydrophilic fumed Silica<br>Synthetic amorphous Silica | | Both device are<br>composed of vinyl<br>terminated siloxane,<br>Filler, platinum<br>catalyst and<br>pigment. | |
| | Pigment | | | |
| | Platinum complex | | | |
| Biocompatibility | Meets ISO 10993-1 for a<br>surface device contacting<br>mucosal membrane and dentin<br>for a short-term contact<br>duration (>24h) | Conforms with ISO 10993-1 | Same | |
| Standards<br>conformed | DIN 13903<br>ISO 10993-1 | DIN 13903<br>ISO 10993-1 | Same | |

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510(k) Summary of Hysil Impression Materials HySil Bite is provided in Appendix B K170736

#### 8. CONCLUSION

Subject devices have the same intended use and the principle of operation as the predicate devices. They are intended to perform as impression materials which meet the requirements according to ISO 4823. Both subject and predicate devices are classified under the same product code (ELW) and have equivalent indications of use (crown and bridge impressions, inlay and onlay impressions for Chemi-SiL (HB, MB, LB, LBS), and impression of the occlusal surface for Chemi-SiL Bite-Blu).

Both devices demonstrate similar physical properties and biocompatibilities with comparable performance specifications to the predicate devices. Information about working time, setting reaction time, consistency, compatibility with gypsum, strain in compression, and linear dimensional change is compared between Chemi-SiL (HB, MB, LB, LBS) and Vonflex STM. Colour, working time, minimum period spent in the mouth, recovery after deformation, load endurance (flexural strength), hardness degree (HD), and linear dimensional change are compared between Chemi-SiL Bite-Blu and Hysil Impression Materials HySil Bite. All subject

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devices have shown better or equivalent performance compared to the predicate device, or have shown compliance with the device-specific standard (ISO 4823) at each endpoint.

In terms of chemical equivalence, the chemical constituents of both devices are analyzed and classified into comparable molecular subgroups. Even though the exact materials do not necessarily coincide, the essential composition of the same; vinyl-terminated siloxane, cross-linking siloxane, silica filler, platinum catalyst, pigments, and surfactant.

In terms of biological equivalence, the bench and biocompatibility testing performed demonstrate that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that the subject devices are substantially equivalent to the predicate devices.