Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses solely on the material composition and intended use within a standard CAD/CAM workflow, with no mention of AI/ML capabilities.

Therapeutic

No
The device is a material (ceramic blocks) used to fabricate dental restorations, not a therapeutic agent itself. It does not directly treat or prevent a disease or condition.

Diagnostic

No
The device is a material (ceramic blocks) used for fabricating dental restorations, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "solid block of material" consisting of physical components like methacrylate and barium glass powder, which are milled into a restorative form. This is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for fabricating dental restorations (inlays, onlays, crowns, bridges) for direct use on a patient. This is a restorative dental material, not a diagnostic test performed on a sample taken from the body.
Device Description: The description details the composition of a solid block of material used for milling, not reagents or equipment for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental ceramic block does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Dental Ceramic Blocks are indicated for fabrication of inlays onlays, aminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

Product codes

EBF

Device Description

Dental Ceramic Blocks consist of methacrylate, benzoyl peroxide, barium glass powder and pigmen to form a solid block of material. The unique marriage of the materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This non-sterile material is milled in a dental CAD/CAM machine into restorative form for single patient use. Dental Ceramic Blocks is provided as non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental professionals and manufacturers

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)

Non-Clinical Performance Test Conclusion
Biocompatibility testing was performed on the proposed device in accordance with the following standards:

. ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
. ISO 10993-10:20101Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests . for systemic toxicity
ISO 10993-6 : 2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
. ISO 10993-3 : 2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

Performance Bench Testing
The basic safety and essential performance comparison test were evaluated based on as following standards:

ISO 4049, Dentistry - Polymer-based Restorative Materials
ISO 7405, Dentistry Evaluation of biocompatibility of medical device used in . dentistry

Animal Study: Animal testing was not required for this submission.

Clinical Studies: No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K222723

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.

Summary

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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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

March 8, 2023

Aidite (Qinhuangdao) Technology Co., Ltd % Julie Chen Consultant ICAS Group 155 Pingbei Rd.Minghang Shanghai, Shanghai 201100 CHINA

Re: K223742

Trade/Device Name: Dental Ceramic Blocks Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 7, 2022 Received: December 29, 2022

Dear Julie Chen:

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.

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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 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 -S

Michael E. Adjodha, M.ChE. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K223742

Device Name

Dental Ceramic Blocks

Indications for Use (Describe)

Dental Ceramic Blocks are indicated for fabrication of inlays onlays, aminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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K223742 510(K) Summary

I. SUBMITTER:

Aidite (Qinhuangdao) Technology Co., Ltd No.9 Dushan Road, Economic and Technological Development Zone,Qinhuangdao City China Contact Person: Chen Yingying Title: Registered Engineer Tel: 15033560085 Email: chenyingying@aidite.com

Submission Correspondent: Julie Chen Email: c1.julie@hotmail.com Tel:+86 139 1804 5781

Summary prepared:02/27/2023

II. DEVICE

Name of Device: Dental Ceramic Blocks Regulation Number: 21 CFR PART 872.3690 Classification Name: Material, tooth shade, resin Regulatory Class: II Product Code: EBF

III. PREDICATE DEVICE

Primary predicate device: K222723(AMBARINO High-Class)

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DEVICE DESCRIPTION IV.

Dental Ceramic Blocks consist of methacrylate, benzoyl peroxide, barium glass powder and pigmen to form a solid block of material. The unique marriage of the materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This non-sterile material is milled in a dental CAD/CAM machine into restorative form for single patient use. Dental Ceramic Blocks is provided as non-sterile.

Model	Shade	Specification
Monochromatic	A1-HT, A2-HT, A3-HT,
A3.5-HT, A4-HT, B1-HT,
B2-HT, B3-HT, B4-HT,
C1-HT, C2-HT, C3-HT,
C4-HT, D2-HT, D3-HT,
D4-HT, BL1-HT, BL2-HT,
BL3-HT, BL4-HT	Disc shape: 16×16, 20×20, 98×10,
98×12, 98×14, 98×16, 98×18, 98×20,
98×22, 98×25, 98×28, 98×30,95×10,
95×12, 95×14, 95×16, 95×18, 95×20,
95×22, 95×25, 95×28, 95×30 (Unit: mm)
		Horseshoe: 92×75×12、92×75×14、
92×75×15、92×75×16、92×75×18、
92×75×20 (Unit: mm)
Multi-Layered	A1-LT, A2-LT, A3-LT, A3.5-LT,
A4-LT, B1-LT, B2-LT, B3-LT,
B4-LT, C1-LT, C2-LT, C3-LT,
C4-LT,D2-LT, D3-LT, D4-LT,
BL1-LT, BL2-LT, BL3-LT,
BL4-LT	Rectangle: 55×15.5×19 、
55×15.5×14、40×15×14、40×15×15、
40×15×19、32×15×15、29×15×14、
20×12×12、20×15×14、20×15×19、
18×16×18 、 18×14.5×14.5 、
18×13×15、18×14×12、15.5×11×13、
15×8×8、 15×10×8、 15×12×10、
14×12×10 (Unit: mm)

V. AVAILABLE MODEL

VI. INTENED USE per 21CFR 807.92(A)(5)

Dental Ceramic Blocks are indicated for fabrication of inlays/onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

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INDICATIONS for USE VII.

Dental Ceramic Blocks are indicated for fabrication of inlays/onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Dental Ceramic Blocks are compared with the predicate device, AMBARINO High-Class (K222723). The results are shown below in the Technological Characteristics Comparison Table:

Item	Proposed Device	Predicate Device	Remark
	Dental Ceramic Blocks	AMBARINO® High-Class
K number	TBD	K222723	--
Regulation Number	21 CFR PART 872.3690	21 CFR PART 872.3690	SE
Product Code	EBF	EBF	SE
Common name	Material, tooth shade, resin	Material, tooth shade, resin	SE
Classification	II	II	SE
Manufacturer	Aidite (Qinhuangdao)
Technology Co., Ltd	Creamed GmbH & Co. Produktions-
und Handels KG	--
Intended Use	Dental Ceramic Blocks are
indicated for fabrication of
inlays/onlays, laminate
veneers, anterior and posterior
full crown restorations, and
implant crowns and bridges by
dental professionals and
manufacturers using a dental
CAD/CAM system.	AMBARINO® High-Class is indicated
for fabrication of inlays / onlays,
laminate veneers, anterior and posterior
full crown restorations, and implant
crowns and bridges by
dental professionals and manufacturers
using a dental CAD/CAM system.	SE
Type Use	Prescription (Rx Only)	Prescription (Rx Only)	SE
Physical State	Cured blocks and discs in a
variety of shapes and shades	Cured blocks and discs in a variety of
shapes and shades	SE
Shapes	Disc Shape and Retangle	Disc Shape and Retangle	SE
Structure	Polymer resin /ceramic hybrid
composite	Polymer resin /ceramic hybrid
composite	SE
Color	Color	Color	SE

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| Materials | UDMA, TEGDMA , EGDMA
BPO, 72% Barium glass
powder, Gaseous silica,
TiO2, Fe2O3, Fe2O3·H2O,
Fe3O4 | 39% UDMA, TEGDMA
61% inorganic
silica-based glass and
silica | Note 1 |
|-------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------|
| Dimension | Various | 14, 98 | Note 2 |
| Flexural Strength | 207 MPa | 191 MPa | Note 3 |
| Radioactive | 2.3mm Al | 1.8mm Al | Note 3 |
| Biocompatibility | Conforms with
ISO 10993-1, FDA Guidance | Conforms with
ISO 10993-1, FDA Guidance | SE |
| Performance | Conforms with
ISO 4049 | Conforms with
ISO 4049 | SE |
| Sterility | Non-Sterile | Non-sterile | SE |
| Single Use | Single Use | Single Use | SE |

Discussion

Note 1 Material

Although the material of the proposed device and the predicate device is different, they meet the requirement of ISO 10993-1 and FDA guidance.

Note 2 Dimension & Note 3 Flexural Strength and Radioactive

The performance testing of the proposed device and the predicate device is complied with ISO 4049 and ISO 7491. Although the results have slightly difference, they meet the acceptance criteria. Therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate devices.

IX. PERFORMANCE DATA

Non-Clinical Performance Test Conclusion

Biocompatibility

Biocompatibility testing was performed on the proposed device in accordance with the following standards:

. ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
. ISO 10993-10:20101Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity

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ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests . for systemic toxicity
ISO 10993-6 : 2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
. ISO 10993-3 : 2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

Performance Bench Testing

The basic safety and essential performance comparison test were evaluated based on as following standards:

ISO 4049, Dentistry - Polymer-based Restorative Materials
ISO 7405, Dentistry Evaluation of biocompatibility of medical device used in . dentistry

Animal Study

Animal testing was not required for this submission.

Clinical Studies

No clinical study is included in this submission.

CONCLUSIONS X.

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device AMBARINO High-Class (K222723).