(151 days)
Not Found
No
The summary describes a material (PMMA block) used in CAD/CAM milling, with no mention of AI/ML in its description, intended use, or performance studies.
Yes
The device is indicated for use in fabricating removable structures for therapeutic restorations like night guards, bite splints, or occlusal splints, which are used to treat certain conditions.
No
Explanation: The device, PMMA BLOCK, is described as a material used for the fabrication of removable or temporary dental structures like crowns, bridges, and splints using CAD/CAM milling technology. Its purpose is to create physical dental prostheses, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly states that the device is a "circular solid (disc) or rectangular solid (block) of PMMA," which is a physical material used in a CAD/CAM milling machine. This indicates it is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of temporary or removable dental structures. This is a mechanical/restorative function, not a diagnostic one.
- Device Description: The device is a material (PMMA block) used in a milling machine to create physical dental prostheses. It doesn't interact with biological samples for diagnostic purposes.
- Performance Studies: The performance studies focus on physical, chemical, and biocompatibility properties of the material itself, which are relevant for a dental restorative material, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This PMMA block does not fit that description.
N/A
Intended Use / 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).
Product codes
EBG, EBI, MQC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
on teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used in hospital, dental clinic and relevant places
dental professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. (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.
Summary of Biocompatibility
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.
Clinical Performance Data
Not applicable. Clinical performance testing has not been performed for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Physical parameters:
Flexural strength:
Subject device: ISO 10477 >= 50 MPa, ISO 20795-1 >= 65 MPa
Predicate device: >= 50 MPa, >= 65 MPa
Water absorption:
Subject device: ISO 10477
§ 872.3770 Temporary crown and bridge resin.
(a)
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.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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, |
| Shanghai, P.R. China | |
| Tel: | 0086- 021-20952966 |
| Contact person and title: | Quansheng Wang, Head of firm |
| walkerwang@leongy.com |
2.2 Submission Correspondent
| Name | Chenhe Medical Consulting Co., Ltd |
|---|---|
| Address | Room 113, 7th Floor, Block B, Building 1, No. A 38, |
| Zhongguancun Street, Haidian District, Beijing, China | |
| Tel: | 086 633 13774915658 |
| Contact person and title: | Jennifer Liu/Regulatory Affairs Manager |
| Jennifer19862022@163.com |
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 | ||||
| MATERIAL CO., LTD. | PMMA BLOCK | K201683 | EBG , 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.
5
(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 | |||||
| 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 | |||||||
| $\geq$ 50 MPa | |||||||
| ISO 20795-1 | |||||||
| $\geq$ 65 MPa | ISO 10477 | ||||||
| $\leq$ 0.040 mg/mm³ | |||||||
| ISO 20795-1 | |||||||
| $\leq$ 0.032 mg/mm³ | ISO 10477 | ||||||
| $\leq$ 0.0075 mg/mm³ | |||||||
| ISO 20795-1 | |||||||
| $\leq$ 0.0016 mg/mm³ | ISO 20795-1 | ||||||
| $\leq$ 2.2% | ISO 22112 | ||||||
| The dimensional change shall be within±2% of its original mesio-distal dimension. | |||||||
| Predicate Device | |||||||
| (K201683) | $\geq$ 50 MPa | ||||||
| $\geq$ 65 MPa | $\leq$ 0.040 mg/mm³ | ||||||
| $\leq$ 0.032 mg/mm³ | $\leq$ 0.0075 mg/mm³ | ||||||
| $\leq$ 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 | |||||
| $\ge$ 65 MPa | $\le$ 0.040 mg/mm³ | |||||
| $\le$ 0.032 mg/mm³ | $\le$ 0.0075 mg/mm³ | |||||
| $\le$ 0.0016 mg/mm³ | $ |