A-Silicone for Bite Registration

K201684 · Shandong Huge Dental Material Corporation · ELW · Sep 24, 2020 · Dental

Device Facts

• Record ID: K201684
• Device Name: A-Silicone for Bite Registration
• Applicant: Shandong Huge Dental Material Corporation
• Product Code: ELW · Dental
• Decision Date: Sep 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

A-Silicone for Bite Registration is indicated for making occlusal registrations.

Device Story

A-Silicone for Bite Registration is a vinylpolysiloxane (addition silicone) impression material used for bite registration. It consists of two components (polydimethylsiloxane, silica, and platinum catalyst) supplied in a 1:1 double cartridge system. When mixed, the components undergo a platinum-catalyzed addition curing reaction to form an elastomeric material. The device is used by dental professionals in surgery or laboratory environments to capture the occlusal relationship of a patient's teeth. The clinician applies the material using a dispenser and mixing tips to record the bite. The resulting cured impression provides a stable, accurate reproduction of the dental structure, aiding in the fabrication of dental restorations or appliances. The device is a passive material and does not involve electronic processing or software.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including physical property testing (consistency, linear dimensional change, detail reproduction, elastic recovery) per ISO 4823 and biocompatibility testing (cytotoxicity, sensitization, irritation) per ISO 10993.

Technological Characteristics

Vinylpolysiloxane (addition silicone) material; two-component platinum-catalyzed system. Supplied in 1:1 double cartridge with dispenser and mixing tips. Complies with ISO 4823 (dentistry elastomeric impression materials) and ISO 10993 (biocompatibility).

Indications for Use

Indicated for making occlusal registrations in dental surgery and laboratory settings.

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

• Occlufast Rock (K024034)

Submission Summary (Full Text)

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September 24, 2020

Maggie Zheng, Regulatory Affairs Manager Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District Rizhao City. CHINA 276800 Shandong Province

#### Re: K201684

Trade/Device Name: A-Silicone for Bite Registration Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: June 15, 2020 Received: June 22, 2020

#### Dear Maggie Zheng:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/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).

Sincerely,

for Srinvas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K201684

Device Name A-Silicone for Bite Registration

Indications for Use (Describe) A-Silicone for Bite Registration is indicated for making occlusal registrations.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## K201684

# 510 (k) Summary

This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.

- 1. Date Summary Prepared: September 24, 2020
- 2. Submitter Information:

| Name | Shandong Huge Dental Material Corporation |
|----------------|----------------------------------------------------------------------------------------------|
| Address | No. 68 Shanhai Road, Donggang District, Rizhao City<br>Shandong Province, 276800, P.R. China |
| Telephone | 086-633-2277285 |
| Fax | 086-633-2277298 |
| Contact Person | Mrs. Maggie Zheng |
| Contact Title | Regulatory Affairs Manager |
| E-mail | [e-mail] |

#### 3. Device Name

Trade name: A-Silicone for Bite Registration

Common name: Bite Registration

Classification name: Impression material (21 CFR 872.3660)

Regulatory Class: II

Product Code: ELW

#### 4. Predicate Device Information

| Table 1: Predicate Device Information | | | | |
|---------------------------------------|-------------------|-------------|--------------|-----------|
| Owner/Operator | Device Trade Name | 510 (k) No. | Product Code | Predicate |
| Zhermack S. P. A. | Occlufast Rock | K024034 | ELW | Primary |

This predicate have not been subject to a design-related recall.

No reference devices were used in this submission.

#### 5. Description of Device

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# HUGE

A-Silicone for Bite Registration is a vinylpolysiloxane (addition silicone), also known as A-Silicones, polyvinyl siloxanes (PVS), or vinyl polysiloxanes (VPS), especially made for bite registration work in the surgery and laboratory. It mainly contains polydimethylsiloxane, silica and platinum catalyst.

## 6. Indications for Use

A-Silicone for Bite Registration is indicated for making occlusal registrations.

#### 7. Technological Characteristics

All components of the A-Silicone for Bite Registration are based upon industry well-known chemistry. A-Silicone for Bite Registration is vinylpolysiloxane based materials which has two components addition-type (platinum-catalyzed) silicone rubber. If two parts were mixed together, it will transform into elastomeric materials by the platinum-catalyzed addition curing reaction. The following table shows the technological characteristics for the subject device and indicates the following similarities and differences with the predicate device:

| Table 4: Technological Characteristics Comparison Table | | | | | | | | | | | | | | | | | | |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Technological<br>Characteristics | Subject device<br>(A-Silicone for Bite Registration) | Primary predicate device<br>(Occlufast Rock, K024034) | | | | | | | | | | | | | | | | |
| Description<br>of Material | Vinylpolysiloxane based | Vinylpolysiloxane based | | | | | | | | | | | | | | | | |
| Mode of Action | Addition-curing bite registration | Addition-curing bite registration | | | | | | | | | | | | | | | | |
| Indications of Use | A-Silicone for Bite Registration is<br>indicated for making occlusal<br>registrations. | Zhermack OCCLUFAST ROCK a dental<br>impression material intended to be<br>placed on a preformed impression tray and<br>used to reproduce the structure of<br>a patient's teeth and gums. | | | | | | | | | | | | | | | | |
| Prescription/over-<br>the-counter use | Prescription | Prescription | | | | | | | | | | | | | | | | |
| Physical Form | Double cartridge system 1:1 | Double cartridge system 1:1 | | | | | | | | | | | | | | | | |
| Accessories | Mixing tips, Dispenser | Mixing tips, Dispenser | | | | | | | | | | | | | | | | |
| Physical Properties | HUGE ZHERMACK Remarks Trade name A Silicone For<br>Bite Registration Occlufast Rock / Consistency<br>(≤35mm) 20mm 23mm Similar Linear dimensional<br>change<br>(<1.5%) - 0.2% - 0.2% Same | | | | | | | | | | | | | | | | | |

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| Table 4: Technological Characteristics Comparison Table | | |
|---------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------|
| Technological<br>Characteristics | Subject device<br>(A-Silicone for Bite Registration) | Primary predicate device<br>(Occlufast Rock, K024034) |
| Detail reproduction<br>(75µm) | 75µm | Same |
| Elastic recovery<br>( $≥$ 96.5%) | 99% | Same |

The subject device and primary predicate device have minor different Indications for Use language. However, the difference in language does not change the intended use or substantial equivalence, both products are intended for bite registration work in the surgery and laboratory. Besides, other comparison items such as description of material, mode of action, physical form, accessories and physical properties, etc. are the same. And both products are supplied for prescription use.

#### 8. Summary of Non-clinical performance testing

#### Physical properties testing

A-Silicone for Bite Registration has similar physical and chemical properties as the predicate devices. A-Silicone for Bite Registration was tested and met the applicable requirements of the FDA Recognized Consensus standard: ISO 4823 Fourth edition 2015-08-01 Dentistry -Elastometric impression materials.

| Summary of Physical Properties Testing | | | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------|
| Items | Requirements per ISO 4823 | Requirements of our company<br>and Pre-test planning approaches<br>and test methods of our company | Test Conclusion |
| Component colours | Different components intended for<br>use in the same mixture shall be<br>supplied in contrasting colours to<br>provide a means of determining<br>when the components have been<br>thoroughly mixed. | Same as ISO 4823 | Satisfactory |
| Consistency | $\leq$ 35mm | Same as ISO 4823 | Satisfactory |
| Linear dimensional<br>change | $\leq$ 1.5% | Same as ISO 4823 | Satisfactory |
| Detail reproduction | 75 $\mu$ m | Same as ISO 4823 | Satisfactory |
| Elastic recovery | $\geq$ 96.5% | Same as ISO 4823 | Satisfactory |

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## Biocompatibility testing

The subject device. A-Silicone for Bite Registration, is substantially equivalent to the predicate device that have been legally marketed for decades and with no clinical adverse events. The formulation of the subject device does not contain any non-conventional chemicals compared to the legally marketed predicate device.

Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity, Sensitization and Irritation.

#### 9. Clinical Performance Data

Not applicable. Clinical performance testing has not been performed for the subject device.

#### 10. Conclusions

Based on the indications for use, technological characteristics, performance testing and other information provided in this premarket notification, the subject device has been shown to be safe and effective for its intended use and the minor differences in indications for use fall within the intended use of the predicate device affecting neither the general intended use nor substantial equivalence. Shandong Huge Dental Material Corporation concludes that the subject device is substantially equivalent to the predicate device described herein.