PMMA BLOCK

K223706 · Huliang(Shanghai) Bio-Tech Co., Ltd. · EBG · May 12, 2023 · Dental

Device Facts

• Record ID: K223706
• Device Name: PMMA BLOCK
• Applicant: Huliang(Shanghai) Bio-Tech Co., Ltd.
• Product Code: EBG · Dental
• Decision Date: May 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM. Indications for Use: - Temporary anterior and posterior crowns; - Temporary anterior and posterior bridges; - Removable structures for dentures; - Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).

Device Story

PMMA BLOCK consists of circular discs or rectangular blocks of polymethylmethacrylate (PMMA); used as raw material for CAD/CAM milling machines. Dental professionals in clinics or hospitals mill these blocks into provisional restorative prostheses (crowns, bridges, dentures, splints). Device provides patient with temporary functional and aesthetic dental restoration; facilitates therapeutic occlusal management. No electronic components or software; purely mechanical material for subtractive manufacturing.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 10477, ISO 20795-1, ISO 22112, and ISO 10993 (biocompatibility including cytotoxicity, sensitization, systemic toxicity, subchronic toxicity, and implantation) demonstrated.

Technological Characteristics

Material: Polymethylmethacrylate (PMMA). Form: Circular discs or rectangular blocks. Manufacturing: CAD/CAM milling. Standards: ISO 10477, ISO 20795-1, ISO 22112, ISO 10993. Sterility: Non-sterile. Energy source: None (mechanical material).

Indications for Use

Indicated for dental patients requiring temporary anterior/posterior crowns, bridges, removable denture structures, or therapeutic restorations (night guards, bite splints, occlusal splints).

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• PMMA BLOCK (K201683)

Submission Summary (Full Text)

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May 12, 2023

Huliang(shanghai) Bio-Tech Co., Ltd. % Jennifer Liu Regulatory Affairs Manager Chenhe Medical Consulting Co., Ltd Room 113, 7th Floor, Block B, Building 1, No. A 38, Zhongguancun Street, Haidian District Beijing, Beijing China

Re: K223706

Trade/Device Name: Pmma Block Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG. EBI, MOC Dated: February 12, 2023 Received: February 13, 2023

Dear Jennifer Liu:

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

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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 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,

# Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K223706

Device Name PMMA BLOCK

Indications for Use (Describe)

PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM.

Indications for Use:

- Temporary anterior and posterior crowns;
- Temporary anterior and posterior bridges;
- Removable structures for dentures;
- Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).

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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### K223706

## 005_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.

#### Date Summary Prepared: May 3, 2023 1.

#### 2. Contact details

#### 2.1 Applicant information:

| Name | Huliang(shanghai) Bio-Tech Co., Ltd. |
|---------------------------|------------------------------------------------------------------------------|
| Address | Room 303, Building 5, Lane2388, Xiu Pu Road, Pudong,<br>Shanghai, P.R. China |
| Tel: | 0086- 021-20952966 |
| Contact person and title: | Quansheng Wang, Head of firm |
| E-mail | [e-mail] |

#### 2.2 Submission Correspondent

| Name | Chenhe Medical Consulting Co., Ltd |
|---------------------------|--------------------------------------------------------------------------------------------------------------|
| Address | Room 113, 7th Floor, Block B, Building 1, No. A 38,<br>Zhongguancun Street, Haidian District, Beijing, China |
| Tel: | 086 633 13774915658 |
| Contact person and title: | Jennifer Liu/Regulatory Affairs Manager |
| E-mail | [e-mail] |

#### 3. Device Name

Trade name: PMMA BLOCK Common name: Crown And Bridge, Temporary, Resin Regulatory Class: II Product Code: EBG, EBI, MQC Classification regulation: 21 CFR 872.3770 Classification Name: Temporary crown and bridge resin

#### 4. Predicate Device Information

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| Owner/Operator | Device Trade Name | 510 (k) No. | Product Code | Predicate |
|-----------------------------------|-------------------|-------------|-----------------------|-----------|
| HUGE DENTAL<br>MATERIAL CO., LTD. | PMMA BLOCK | K201683 | <b>EBG</b> , EBI, MQC | Primary |

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

No reference devices were used in this submission.

#### 5. Description of Device

PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.

#### 6. Indications for Use

PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM.

Indications for Use:

- Temporary anterior and posterior crowns;
- Temporary anterior and posterior bridges;
- Removable structures for dentures;
- Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).

#### 7. Summary of Physical and Chemical Properties Tests

- Chemical Composition:
The device has similar chemical composition as the predicate device (Polymethylmetacrilate).

- Technological characteristics: ●
The device has the same technological characteristics as the predicate device (Hot cured

PMMA). And the device is similar in sizes, shapes and color scale as the predicate

devices.

- Properties:
The device has comparable physical and chemical properties as the predicate device.

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(Meeting the requirements of ISO standards for the polymer-based dental materials,

ISO 10477, 20795-1, 22112)

Usage: ●

The device has similar indications for use as the sum of the predicate devices: making removable or temporary dental structures such as crowns and bridges by CAD/CAM or removable dental structures like denture bases and bite splints.

#### 8. Technological Characteristics

All components of the subject device are based upon industry well-known chemistry. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate device:

| | | | Subject Device | | Predicate Device | | |
|----|----------------------------|-------------------------------|------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------|
| | Comparison Items | | PMMA BLOCK | | PMMA Block<br>K201683 | | |
| 1) | Regulatory Classifications | | Same | | Same | | |
| 2) | Indications for use | | Same | | Same | | |
| 3) | Contraindications | | Same | | Same | | |
| 4) | Composition of Materials | | PMMA | | PMMA | | |
| 5) | Physical Properties | Physical parameters | Flexural strength | Water absorption | Water solubility | Residual monomer content | Dimensional stability |
| | | | ISO 10477<br>$\geq$ 50 MPa<br>ISO 20795-1<br>$\geq$ 65 MPa | ISO 10477<br>$\leq$ 0.040 mg/mm³<br>ISO 20795-1<br>$\leq$ 0.032 mg/mm³ | ISO 10477<br>$\leq$ 0.0075 mg/mm³<br>ISO 20795-1<br>$\leq$ 0.0016 mg/mm³ | ISO 20795-1<br>$\leq$ 2.2% | ISO 22112<br>The dimensional change shall be within±2% of its original mesio-distal dimension. |
| | | Predicate Device<br>(K201683) | $\geq$ 50 MPa<br>$\geq$ 65 MPa | $\leq$ 0.040 mg/mm³<br>$\leq$ 0.032 mg/mm³ | $\leq$ 0.0075 mg/mm³<br>$\leq$ 0.0016 mg/mm³ | $\leq$ 2.2% | 0.29% |

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| Table 4: Device Comparison Table | | | | | | |
|----------------------------------|------------------------------------------------------------|------------------------------|------------------------------------------------------------|--------------------------------------------|----------|------|
| Comparison Items | Subject Device | Predicate Device | | | | |
| | PMMA BLOCK | PMMA Block | | | | |
| | | K201683 | | | | |
| | Subject device | $\ge$ 50 MPa<br>$\ge$ 65 MPa | $\le$ 0.040 mg/mm³<br>$\le$ 0.032 mg/mm³ | $\le$ 0.0075 mg/mm³<br>$\le$ 0.0016 mg/mm³ | $<$ 2.2% | 0.9% |
| 6) Labeling | similar | | similar | | | |
| 7) Target Population | dental patients | | dental patients | | | |
| 8) Anatomical Site | on teeth | | on teeth | | | |
| 9) Where Used | used in hospital, dental clinic and relevant places | | used in hospital, dental clinic and relevant places | | | |
| 10) Human Factors | dental professional | | dental professional | | | |
| 11) Design | Circular solid (disc) or rectangular solid (block) of PMMA | | Circular solid (disc) or rectangular solid (block) of PMMA | | | |
| 12) Cautions | similar | | similar | | | |
| 13) Standards Met | same | | same | | | |
| 14) Biocompatibility | ISO 10993-5<br>Non cytotoxic | | ISO 10993-5<br>Non cytotoxic | | | |
| 15) Sterility | Non-sterile | | Non-sterile | | | |
| 16) Chemical Safety | similar | | similar | | | |

#### 9. Summary of Biocompatibility

The new device, PMMA BLOCK, is substantially equivalent to the predicate devices that have been legally marketed for decades and with no clinical adverse events. The formulation of new 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 The test items include Cytotoxicity, Sensitization, Systemic Toxicity, Subchronic Toxicity and Implantation.

#### 10. Clinical Performance Data

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

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#### 11. Conclusions

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the subject device has been shown to be substantially equivalent to the predicate for its intended use. Huliang(shanghai) Bio-Tech Co., Ltd. concludes that the subject device is substantially equivalent to the predicate devices described herein.