(682 days)
Not Found
No
The summary describes a material (PMMA) used for fabricating temporary dental restorations. The design process is mentioned as using CAD technology, which is a standard design tool and does not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is a material (PMMA block) used for the fabrication of temporary crowns and bridges, which are restorative dental devices, not therapeutic.
No
The device is described as a material for fabricating temporary crowns and bridges, which is a therapeutic or restorative function, not a diagnostic one. Its intended use is to be placed in the oral cavity while awaiting a permanent restoration, and the performance studies focus on material properties and biocompatibility.
No
The device description clearly states it is a physical material (PMMA) used for fabricating temporary crowns and bridges, which are physical medical devices. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a material (PMMA) used for fabricating temporary dental restorations (crowns and bridges). It is a physical material placed in the oral cavity.
- Intended Use: The intended use is for the fabrication and placement of temporary dental prosthetics, not for testing biological samples to diagnose or monitor a medical condition.
The device is a dental material used in a restorative procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.
Product codes
EBG
Device Description
The Aidite Pmma is a homogeneous high polymer material made from PMMA (polymethylmethacrylate) added with cross-linking agents to improve the network structure through a unique polymerization molding technology. The device is for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental professional (such as a dentist) using CAD technology.
The proposed device contains two models with different shape: Cylinder and Cuboid. There are 40 specifications for Cylinder model (variation in different diameters and heights), and 24 specifications for Cuboid model (variation in different lengths, widths, and heights).
There are 17 various shades of the proposed device: 1 is transparent (without color added), the other 16 shades are colored (with different coloring matters added). The 16 shades created based on 16 Vita Shades contain A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4.
The Aidite Pmma would be produced on the 40 specifications of Cylinder model or 24 specifications of Cuboid model, with a shade chosen from the 17 various shades.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental Professional (Technician)
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)
-
Biocompatibility test: The Aidite Pmma is classified as surface-contacting device. For duration of contact, the Aidite Pmma is considered as permanent contact devices. In accordance with ISO 10993-1 and ISO 7405, the biocompatibility tests contain: ISO 7405: 2008 & ISO 10993-5: 2009 Agar diffusion test; ISO 7405: 2008 & ISO 10993-5: 2009 Filter diffusion test; ISO 10993-5: 2009 In Vitro cytotoxicity test; ISO 10993-10: 2010 Skin sensitization test; ISO 10993-10: 2010 Oral mucosa irritation test; ISO 10993-11: 2017 Subchronic systemic toxicity; ISO 10993-3: 2014 Genotoxicity.
-
Shelf life validation test: The shelf life validation test of the proposed devices was conducted after accelerated aging for 2 years (ASTM F 1980).
-
Performance test: The performance of Aidite Pmma contains surface finish, flexural strength, bond strength, water sorption and solubility, shade consistency and color stability. All the results meet the acceptance criteria, they also demonstrate that the Aidite Pmma meet the performance characteristics and are substantially equivalent to the legally marketed predicate devices. The performance tests were conducted in accordance with the following standards: ISO 10477: 2018 Dentistry-Polymer-based crown and bridge materials; ISO 7491: 2000 Dental materials-Determination of color stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural strength ≥50 MPa
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2020
Aidite (Qinhuangdao) Technology Co., Ltd. % Jessie You Official Correspondent Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou middle road , Nanshan District Shenzhen, GD755 CHINA
Re: K190217
Trade/Device Name: Aidite Pmma Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: November 26, 2020 Received: December 4, 2020
Dear Jessie You:
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
1
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant 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
2
Indications for Use
510(k) Number (if known) K190217
Device Name Aidite Pmma
Indications for Use (Describe)
The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.
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) |
imption 500 (Part 21 CFR 1301, Subpart B)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
1. Submission Sponsor
| Applicant Name | Aidite (Qinhuangdao) Technology Co., Ltd. |
|---|---|
| Address | No.9 Dushan Road, Economic and Technological |
| Development Zone, Qinhuangdao, Hebei, China. | |
| Post Code | 066000 |
| Phone No. | +86 335 8587898 |
| Fax No. | +86 335 8587198 |
| Contact Person | Ms. Zhang Wei |
| zhangwei@aidite.com | |
| Date Prepared | 2020-12-10 |
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | Room 1122, No.55 Shizhou Middle Road, Nanshan |
| District, | |
| Shenzhen, | |
| Guangdong, | |
| P.R.China | |
| Image: Company Logo | |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Mr. Field Fu; Ms. Jessie You; Ms. Elly Xu |
| Jessie@cefda.com; Elly@cefda.com |
3. Devices Identification
| Trade name | Aidite Pmma |
|---|---|
| Models | Cylinder and Cuboid |
| Device class | II |
| Classification name | Crown and Bridge, Temporary, Resin |
| Product code | EBG |
| Regulation number | 21 CFR 872.3770 |
| Regulation description | Temporary crown and bridge resin |
| Regulation medical specialty | Dental |
4. Legally Marketed Predicate Devices
| Trade name | PMMA Block |
|---|---|
| 510(K) Number | K141421 |
| Manufacturer | Rizhao Huge Dental Industry Co., Ltd |
| Device class | II |
4
| Classification name | Crown and Bridge, Temporary, Resin |
|---|---|
| Product code | EBG |
| Regulation number | 21 CFR 872.3770 |
| Regulation description | Temporary crown and bridge resin |
| Regulation medical specialty | Dental |
5. Device Description
The Aidite Pmma is a homogeneous high polymer material made from PMMA (polymethylmethacrylate) added with cross-linking agents to improve the network structure through a unique polymerization molding technology. The device is for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental professional (such as a dentist) using CAD technology.
The proposed device contains two models with different shape: Cylinder and Cuboid. There are 40 specifications for Cylinder model (variation in different diameters and heights), and 24 specifications for Cuboid model (variation in different lengths, widths, and heights).
There are 17 various shades of the proposed device: 1 is transparent (without color added), the other 16 shades are colored (with different coloring matters added). The 16 shades created based on 16 Vita Shades contain A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4.
The Aidite Pmma would be produced on the 40 specifications of Cylinder model or 24 specifications of Cuboid model, with a shade chosen from the 17 various shades.
6. Indications for Use Statement
The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.
7. Substantial Equivalence Discussion
| Table 1: Substantial equivalence comparison | ||
|---|---|---|
| --------------------------------------------- | -- | -- |
| Items | Proposed device | Predicate device | Comments |
|---|---|---|---|
| Trade name | Aidite Pmma | PMMA Block | / |
| 510(K) | |||
| submitter | Aidite (Qinhuangdao) | ||
| Technology Co., Ltd. | Rizhao Huge Dental | ||
| Industry Co., Ltd | / | ||
| 510(K) number | K190217 | K141421 | / |
| Classification | 21 CFR 872.3770 | 21 CFR 872.3770 | Same |
5
| regulation | Temporary crown and
bridge resin | Temporary crown and
bridge resin | Temporary crown and
bridge resin |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Classification
and product
code | II
EBG | II
EBG | Same |
| Indication for
use | The device is made from
PMMA
(polymethylmethacrylate
) for the fabrication of
temporary crowns and
bridges and is intended
for use in the oral cavity
for up to six (6) months
while awaiting a
permanent restoration.
Restorations are
designed and
manufactured by a
dental Professional
(Technician) using CAD
technology. | A device made from
PMMA
(polymethylmethacrylate
) for the fabrication of
temporary crowns and
bridges and is intended
for use in the oral cavity
for up to six (6) months
while awaiting a
permanent restoration.
Restorations are
designed and
manufactured by a
dental Professional
(Technician) using CAD
technology. | Same |
| Material of
construction | PMMA | PMMA | Same |
| Shades | 17 Shades
(Transparent, 16 Vita
Shades) | 20 Vita Shades | Different
Issue 1 |
| Processing
method | Variable Thickness
Milling Blank and
machined using any
milling system | Variable Thickness
Milling Blank and
machined using any
milling system | Same |
| Flexural
strength | ≥50 MPa | ≥50 MPa | Same |
| Shelf life | 2 years | 5 years | Different
Issue 2 |
| Performance
effectiveness | Tested according to ISO
10477 | Tested according to ISO
10477 | Same |
| Performance
safety | Tested according to ISO
10993 standards | Tested according to ISO
10993 standards | Same |
lssue 1: The transparent shade is made from PMMA without color added. The 16 Vita shades are designed in accordance with VITA classical A1-D4. The shade consistency, color stability and the biocompatibility of Aidite Pmma has been evaluated by conducting tests.
6
Issue 2: The 2-year shelf life of the proposed device has been proved by conducting accelerated aging test.
8. Non-Clinical Performance Data
1) Biocompatibility test
The Aidite Pmma is classified as surface-contacting device. For duration of contact, the Aidite Pmma is considered as permanent contact devices. In accordance with ISO 10993-1 and ISO 7405, the biocompatibility tests contain: ISO 7405: 2008 & ISO 10993-5: 2009 Agar diffusion test ISO 7405: 2008 & ISO 10993-5: 2009 Filter diffusion test ISO 10993-5: 2009 In Vitro cytotoxicity test ISO 10993-10: 2010 Skin sensitization test ISO 10993-10: 2010 Oral mucosa irritation test ISO 10993-11: 2017 Subchronic systemic toxicity ISO 10993-3: 2014 Genotoxicity
2) Shelf life validation test
The shelf life validation test of the proposed devices was conducted after accelerated aging for 2 years (ASTM F 1980):
Performance test-bench 3)
The performance of Aidite Pmma contains surface finish, flexural strength, bond strength, water sorption and solubility, shade consistency and color stability. All the results meet the acceptance criteria, they also demonstrate that the Aidite Pmma meet the performance characteristics and are substantially equivalent to the legally marketed predicate devices. The performance tests were conducted in accordance with the following standards:
ISO 10477: 2018 Dentistry-Polymer-based crown and bridge materials; ISO 7491: 2000 Dental materials-Determination of color stability.
9. Statement of Substantial Equivalence
The Indications for Use and technological characteristics for Aidite Pmma are same to the referenced predicate devices (K141421). The non-clinical performance testing demonstrates that the proposed device is substantially equivalent to the predicate devices. Therefore, the results show that it is Substantially Equivalent (SE) between the proposed device and the predicate device.