K Number

Device Name

Franz Zirconia Dental Crown

Manufacturer

Franz Biotech Inc.

Date Cleared

2022-01-19

(467 days)

Product Code

ELL

Regulation Number

872.3920

Intended Use

Device Description

Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function. Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment. Franz Zirconia Dental Crown is intended to be a replacement for a natural tooth. After finalizing the Franz Zirconia Dental Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth. To achieve esthetics and required value and chroma of the surrounding natural teeth the Franz Zirconia Dental Crown is suitable for cut-back (veneering) or stain and glaze techniques. The design of the Franz Zirconia Dental Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using or supported third party CAD systems. The crown, once ordered, is sent electronically to one of Franz's centralized milling centers for fabrication.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K153534

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical dental crown and its fabrication process, with no mention of AI or ML in its function or design determination. The design is determined using third-party CAD systems, which are not inherently AI/ML.

Therapeutic

Yes
The device is described as a replacement for a natural tooth and is used to restore chewing function, which constitutes a therapeutic purpose.

Diagnostic

The device is a dental crown, which is a prosthesis used to restore chewing function and replace a natural tooth, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical dental crown made of zirconia, which is a hardware component. While software (CAD systems) is used in the design process, the device itself is a physical object.

IVD (In Vitro Diagnostic)

Based on the provided information, the Franz Zirconia Dental Crown is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to replace a natural tooth and restore chewing function in partially edentulous patients. This is a structural and functional replacement within the body.
Device Description: The description details the material (zirconia), the process of design and fabrication, and how it is cemented or bonded to an abutment. This is a physical device for implantation/placement in the mouth.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.

IVD devices are typically used to test samples like blood, urine, or tissue outside of the body to provide diagnostic information. The Franz Zirconia Dental Crown is a prosthetic device placed within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

Product codes

ELL

Device Description

Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

Franz Zirconia Dental Crown is intended to be a replacement for a natural tooth. After finalizing the Franz Zirconia Dental Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.

To achieve esthetics and required value and chroma of the surrounding natural teeth the Franz Zirconia Dental Crown is suitable for cut-back (veneering) or stain and glaze techniques.

The design of the Franz Zirconia Dental Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using or supported third party CAD systems. The crown, once ordered, is sent electronically to one of Franz's centralized milling centers for fabrication.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth/teeth, specifically for partially edentulous patients requiring prosthetic oral reconstruction.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental laboratory, hospital or dental practice (clinician)

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 has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device.

ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] Dentistry - Ceramic materials

Biocompatibility testing

The biocompatibility evaluation and testing of the Product name was conducted in accordance with the following standards and guidance, as recognized by the FDA:

. ISO 10993-1:2018(en) Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
. ISO 10993-3:2014, Biological evaluation of medical device-Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity.
. ISO 10993-5:2009, Biological evaluation of medical device-Part 5: Tests for in vitro cytotoxicity.
. ISO 10993-10:2010, Biological evaluation of medical device-Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2017, Biological evaluation of medical device-Part 11: Tests for . systemic toxicity.
ISO 10993-12:2012, Biological evaluation of medical device-Part 12: Sample . preparation and reference materials.

Mechanical testing

Franz Zirconia Dental Crown's mechanical function including Radioactivity Test, Biaxial flexural strength, Linear thermal expansion coefficient test and Fracture toughness tests which were tested and demonstrated that the design specification from design input are fulfilled. Mechanical safety tests were also conducted to demonstrate that the reliability of the device for during use no safety concern.

No animal studies or clinical testing have been required for these devices.

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

Not Found

Predicate Device(s)

K153534

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3920 Porcelain tooth.

(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.

Summary

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 and Human Services logo. To the right of that 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.

January 19, 2022

Franz Biotech Inc. Anita Chen Official Applicant 5F .- 3, No. 56, Ln. 258, Ruiguang Rd., Neihu Dist. Taipei City, Taiwan 114 TAIWAN

Re: K203072

Trade/Device Name: Franz Zirconia Dental Crown Regulation Number: 21 CFR 872.3920 Regulation Name: Porcelain Tooth Regulatory Class: Class II Product Code: ELL Dated: December 22, 2021 Received: December 22, 2021

Dear Anita 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.

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 (OS) 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 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

Indications for Use

510(k) Number (if known) K203072

Device Name Franz Zirconia Dental Crown

Indications for Use (Describe)

Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

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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K203072

510(k) Summary

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92

The assigned 510(k) Number: K203072

1.	Submitter
	Mailing Address	Franz Biotech Inc.
4F, No. 167, Sec. 5, Minsheng E. Rd., Songshan
Dist., Taipei City 105, Taiwan (R.O.C.)
	Factory Address	5F.-3, No. 56, Ln. 258, Ruiguang Rd., Neihu
Dist., Taipei City 114,
Taiwan (R.O.C.)Establishment Registration No.
1st submission
	Contact Person	Anita Chen
	Phone:	+886(0) 939-855-759
	E-mail:	m9104303@gmail.com
	Date Prepared	August 6, 2020
2	Device Name
	Common or Usual Name	Porcelain tooth
	Regulation Description	Porcelain tooth
	Product Code	ELL
	Device	Franz Zirconia Dental Crown
	CFR Classification	CFR Part 872.3920
	Device Class	II
	Classification Panel	Dental
3	Predicate Device Name
	510(k) number:	K153534
	Trade or proprietary or
model name:	NobelProcera HT ML Full Contour Zirconia
Crown
	Manufacturer:	NobelBiocare AB
Vastra Hamngatan 1
Goteborg, SE-411 17

Sweden

Device Description: 4

Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

To achieve esthetics and required value and chroma of the surrounding natural teeth the Franz Zirconia Dental Crown is suitable for cut-back (veneering) or stain and glaze techniques.

Indications for Use: న.

Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis

for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.

Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

Franz Dental Zirconia Crown is intended to be a replacement for a natural tooth.

1. Technological Characteristics and Substantial Equivalence Comparison with Predicate:
  Intended Use

A comparison of the device features, intended use, and other information demonstrates that the Franz Dental Zirconia Crown is substantially equivalent to the predicate device as summarized in Table 1. A minor technological differences between the predicate device and subject device was made by 3D print process, the predicate device was made by CNC. The materials, size, shape was totally the same with the predicate device. Both device was used the same technological for CAD. Although there is a slightly different technological for manufacturer process, as compared to the predicate, the performance data demonstrates the proposed device performs as safely and effectively as the predicate device. The differences raise no new question of safety and effectiveness.

	Candidate Device	Predicate Device
Manufacturer	Franz biotech Inc.	Nobel Biocare AB
Device Name	Franz Zirconia Dental
Crown	NobelProcera HT ML Full
Contour Zirconia Crown
510(k) Number	K203072	K153534
Regulation
Number	21 CFR 872.3920	21 CFR 872.3920
Regulation
Name	Porcelain Tooth	Porcelain Tooth
Intended Use	Intended to be a replacement
for a natural tooth.	Intended for use as an aid in
prosthetic rehabilitation
	Franz Zirconia Dental Crown	NobelProcera HT ML FCZ
Indications for
Use	is indicated for use as main
structure of an artificial dental
prothesis for partially
edentulous patients which
require prosthetic oral
reconstruction to restore
chewing function.
Franz Zirconia Dental Crown
is indicated for use as single
crown that will be cemented
to an artificial or natural tooth
abutment._	Crown is indicated for use as
core structure of an artificial
prosthesis for partially
edentulous
patients in the need of
prosthetic oral reconstruction
in order to restore chewing
function.
NobelProcera HT ML FCZ
Crown is indicated for use as
single crown that will be
cemented to a natural or
artificial tooth
abutment.
Material	Y-TZP Zirconium Oxide	Y-TZP Zirconium Oxide
(Katana Zirconia K143439)
Manufacturing
Method	Franz biotech in-house 3D-
printing (Additive
Manufacturing; AM)	Nobel Biocare in-house
CAM
Minimum
Thickness	0.4mm (Anterior)
0.7mm (Pre-molar and Molar)	0.4mm (Anterior)
0.7mm (Pre-molar and
Molar)
Number of units	Individual crown	Individual crown
Single Use	Yes	Yes
Number of units	Individual Crown	Individual crown
Biaxial Flexural
Strength
(MPa)
(sintered)	Means±(SD)
1061(90)	Means±(SD)
1092(112)
Fracture
Toughness
(MPam0.5)	6.44	Unknow
Thermal
Expansion
(um/m°C)	9.95	10.80
Chemical
Solubility in
Water
(ug/cm²)