Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the material composition and physical properties of dental ceramic materials, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are based on material standards (ISO 6872), not algorithmic performance.

Therapeutic

No.
The device, Dental Ceramic, is indicated for use in creating full and partial veneers for dental restorations, which are considered prosthetic devices rather than therapeutic (treating or curing a disease/condition).

Diagnostic

No
The device is a dental ceramic material used to create prosthetic teeth (full or partial veneers), not to diagnose medical conditions. Its purpose is restorative, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a ceramic material made of various chemical compounds used to form dental restorations, indicating it 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:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that this Dental Ceramic is used to "form the whole or part of a dental restoration or prosthesis" for "simulation tooth of human". It is a material used to build or repair teeth.
Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens from a patient. Its function is purely structural and restorative.
Performance Testing: The performance testing described (flexural strength, solubility, glass transition temperature) relates to the physical and chemical properties of the material itself, not its ability to detect or measure substances in a biological sample.

Therefore, this Dental Ceramic falls under the category of a dental restorative material, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Dental Ceramic is indicated for use for metal-ceramic full veneers and for zirconia full veneers and partial veneers.

Product codes

EIH

Device Description

Dental Ceramic divided into two categories: Metal Ceramic; Zirconia Ceramic.

They are used to be made for simulation tooth of human whose ages above 18. After fired, form the whole or part of a dental restoration or prosthesis. It is made by Aluminium oxide(Al2O3), Silicon dioxide (SiO2), Potassium carbonate (K2CO3), Sodium carbonate (Na2CO3), Calcium oxide (CaO), Zirconium dioxide (ZrO2),

Metal Ceramic :a complete metallic substructure of Dental Ceramic are Glaze separated two parts-metal and ceramic, which is made of metal alloys and whose inner is a framework. The materials within the metallic is broadly divided into three categories: precious metal, semiprecious metal alloys and non-precious metal alloys, being usually called inner alloy crown.

Zirconia Ceramic : A complete Zirconia Ceramics are separated two parts-Zirconia coping and porcelain layer (Dentin layer and Enamel layer), as shown in the figure, the innermost layer of dental ceramic is Zirconia coping which is a framework. It has a positive impact on bearing and combining closely with the dentin layer.

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

human whose ages above 18

Intended User / Care Setting

Not Found

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)

Performance testing was conducted in accordance with ISO 6872:2008 Dentistry - Ceramic materials. The Dental Ceramic is classified as a Type I, Class 1 device and met the standard requirements per ISO 6872:2015. We also provided a comparison between ISO 6872:2008 and ISO 6872:2015, effects of changes to materials properties.

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

Flexural strength:
- METAL CERAMIC OPAQUE :98.63MPa
- DENTINE :98.07Mpa
- ENAMEL :102.48Mpa
- ZIRCONIA CERAMIC DENTINE :92.56MPa
- ENAMEL :98.87MPa
Solubility:
- METAL CERAMIC OPAQUE :15.88µg.cm-2
- DENTINE :36.77µg.cm-2
- ENAMEL :18.40µg.cm-2
- ZIRCONIA CERAMIC DENTINE :18.17µg.cm-2
- ENAMEL :28.60µg.cm-2
Glass transition temperature:
- METAL CERAMIC OPAQUE :575°C
- DENTINE : 575°C
- ENAMEL : 575°C
- ZIRCONIA CERAMIC DENTINE : 590°C
- ENAMEL : 590°C

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140848

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(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). 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.

May 22, 2019

Baot Biological Technology Co., LTD Ligun Zhu Quality Manager Unit 1, Second Floor, No 12 Building, Yujing Industry Zone, 106 Qihao Road, Torch Development District Zhongshan, 528437 CHINA

Re: K182350

Trade/Device Name: Dental Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: February 21, 2019 Received: February 21, 2019

Dear Liqun Zhu:

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.

1

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Malvina Eydelman, M.D. Director 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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Indications for Use

510(k) Number (if known) K182350

Device Name

Dental Ceramic (Model: Metal Ceramic; Zirconia Ceramic)

Indications for Use (Describe)

Dental Ceramic is indicated for use for metal-ceramic full veneers and for zirconia full veneers and partial veneers.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) SUMMARY

K182350

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	BAOT BIOLOGICAL TECHNOLOGY CO.,LTD
Address:	Unit 1, Second Floor, No 12 Building, Yujing Industry
Zone, 106 Qihao Road, Torch Development District,
Zhongshan City, Guangdong, P.R. China
	Zip Code: 528437
Company Phone No:	+86 760 87893826
Company Fax No:	+86 760 87893827
Contact Person:	Liqun Zhu
E-mail:	baotw@baot.biz
Date summary prepared:	August 10, 2018

2. Device Identification

| Device Trade Name: | Dental Ceramic (Model: Metal Ceramic; Zirconia
Ceramic) |
|---------------------|------------------------------------------------------------|
| Classification Name | powder, porcelain |
| Regulation Number: | 21 CFR 872.6660 |
| Regulation Name: | Porcelain Powder For Clinical Use |
| Regulation Class: | II |
| Product Code: | FIH |

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004 510(k) summary

3. Predicate Devices

Device Trade Name:	Luminesse Porcelain System
510(k) Number;	K140848
Regulation Name:	Porcelain Powder For Clinical Use
Class:	II
Classification Panel:	Dental
Product Code:	EIH
Regulation Number:	21 CFR 872.6660

4. Device Description

Dental Ceramic divided into two categories: Metal Ceramic; Zirconia Ceramic.

They are used to be made for simulation tooth of human whose ages above 18. After fired, form the whole or part of a dental restoration or prosthesis. It is made by Aluminium oxide(Al2O3), Silicon dioxide (SiO2), Potassium carbonate (K2CO3), Sodium carbonate (Na2CO3), Calcium oxide (CaO), Zirconium dioxide (ZrO2),

Metal Ceramic :a complete metallic substructure of Dental Ceramic are Glaze separated two parts-metal and ceramic, which is made of metal alloys and whose inner is a framework. The materials within the metallic is broadly divided into three categories: precious metal, semiprecious metal alloys and non-precious metal alloys, being usually called inner alloy crown.

Zirconia Ceramic : A complete Zirconia Ceramics are separated two parts-Zirconia coping and porcelain layer (Dentin layer and Enamel layer), as shown in the figure, the innermost layer of dental ceramic is Zirconia coping which is a framework. It has a positive impact on bearing and combining closely with the dentin layer.

5. Intended Use / Indications for Use

Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers.

6. Substantial Equivalence

A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows.

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004_510(k) summary

Feature	Our device	Luminesse Porcelain (K140848)
Indications For
Use:	Dental Ceramic is
indicated for use for
metal-ceramic full veneers
and partial veneers and
for zirconia full veneers
and partial veneers.	The Luminesse Porcelain System
is dental porcelain material to be
used in conjunction with metal,
zirconia, or pressable ceramic
framework in the construction of
crowns and/or bridgework and
veneers.	Different
The description of the
intended use is
different, but it is the
same as product
form, the actual use
and methods, and the
change of descrption
for IFU does not
cause unknown
safety problems.
Chemical
composition	Aluminium oxide(Al2O3),
Silicon dioxide (SiO2),
Potassium carbonate
(K2CO3), Sodium
carbonate (Na2CO3),
Calcium oxide (CaO),
Zirconium dioxide (ZrO2)	Equivalent devices are compared
with predicate products
(K981490), the comments shows
that Most all oxides are present in
both Luminesse High-Fusing and
Willi Geller Creation CC porcelain,
it included varying proportions of
silicon dioxide, aluminum dioxide,
sodium oxide, potassium oxide,
tin oxide, barium oxide and iron
oxide. Chemically stable mixed
metal oxides, including spinel,
baddeleyit, zircon, and periclase
phases of zirconium, iron, cobalt,
chromium, yttrium, cerium, nickel
and zinc oxides, are used in trace
amounts for pigmentation. The
paste opaques are comprised of
ceramic powder fitting this
description suspended in glycerol,
zinc chloride, sodium acetate,
propandiol, and aerosol. The
stains are composed of silicon
dioxide, aluminum oxide, potassium
oxide, tin oxide, barium oxide,	Different
The predicate device
state that it included
varying proportions of
silicon dioxide,
aluminum dioxide,
sodium oxide,
potassium oxide, tin
oxide, barium oxide
and iron oxide.
We performed
Biocompatibility test
and ISO 6872 test,
the test result shows
that Components of
our product met
requirements of
biocompatibility and
performance. The
difference does not
cause unknown
safety problems.
		iron oxide, and calcium oxide, and
chemically stable mixed metal
oxides for pigmentation.
Classification
Code	21 CFR 872.6660
Product Code: EIH	21 CFR 872.6660
Product Code: EIH	Same
Flexural
strength	METAL CERAMIC
OPAQUE :98.63MPa
DENTINE :98.07Mpa
ENAMEL :102.48Mpa
ZIRCONIA CERAMIC
DENTINE :92.56MPa
ENAMEL :98.87MPa	Met the requirements of ISO 6872	The predicate
device(K140848) do
not list the main
technological
characteristic in the
510(k) summary, it
just state that Bench
testing to determine
flexural strength,
solubility, and glass
Solubility	METAL CERAMIC
OPAQUE :15.88µg.cm-2
DENTINE :36.77µg.cm-2
ENAMEL :18.40µg.cm-2
ZIRCONIA CERAMIC
DENTINE :18.17µg.cm-2
ENAMEL :28.60µg.cm-2	Met the requirements of ISO 6872	transition temperature
was conducted in
accordance with ISO

We also performed
the bench test in
accordance with ISO
6872. The test results
can prove our product
met the requirements |
| Glass transition
temperature | METAL CERAMIC
OPAQUE :575°C
DENTINE : 575°C
ENAMEL : 575°C
ZIRCONIA CERAMIC
DENTINE : 590°C
ENAMEL : 590°C | Met the requirements of ISO 6872 | of ISO 6872, we think
the lack of
performance data of
predicate device do
not does not cause
unknown safety
problems. |
| Biocompatibility | Met the requirements of
ISO 10993-1,-3,-5,-10,-11,
USP40 | Components of this product have
not changed in any way from the
predicate that would adversely
affect biocompatibility; therefore, | Different
We performed ISO
10993 test to prove |
| | it is determined that no
biocompatibility testing is
necessary for this product. | our product's
biocompatibility. | |

6

004_510(k) summary

7

7. Biocompatibility Testing

Our product belong to external communicating device which contact dentin more than 30 days, we have conducted biological evaluations based on the requirements of ISO 10993-1 and other similar dental materials, as below :

Ames Test ISO 10993-3 Biological evaluation of medical devices Part 3: Tests for i genotoxicity, carcinogenicity and reproductive toxicity.
-In Vitro Cytotoxicity Test - ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-Oral MucOsa Irritation - ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-Skin sensitization - ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Pyrogen Test ISO 10993-11 and USP40Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
-Acute systemic Toxicity Test - ISO 10993-11 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
Subchronic systemic Toxicity Test ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

8. Performance testing :

Performance testing was conducted in accordance with ISO 6872:2008 Dentistry - Ceramic materials. The Dental Ceramic is classified as a Type I, Class 1 device and met the standard requirements per ISO 6872:2015. We also provided a comparison between ISO 6872:2008 and ISO 6872:2015, effects of changes to materials properties.

9. Conclusions:

It has the same technological characteristics, manufacturing process, and similar intended use, chemical composition, as the predicate devices. Our products are substantially equivalent as its predicate device.