Protective Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdenture, and can be used for a minimum of 1 day to maximum of 10 days.

Device Description

The Protective Cap is a dental implant superstructure made of PC(Polycarbonate) according to ASTM F997. It is used temporarily, such as less than 10 days before the final restoration is connected. The Protective Cap is supplied nonsterile and intended for single use. It is to be sterilized by end users before use.

AI/ML Overview

This FDA 510(k) premarket notification for the "Protective Cap" device does not involve an AI/ML algorithm. Therefore, the requested information about acceptance criteria, study details, ground truth, and sample sizes for AI/ML performance evaluation is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the non-clinical testing data provided, which serves as the "study" to meet the "acceptance criteria" for safety and effectiveness in this context:

Non-Clinical Testing Data (Acceptance Criteria & Device Performance):

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance/Conclusion
Sterilization Validation	End User Sterilization Validation (according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1)	Recommended sterilization validated according to standards. Worst-case construct tested.
Biocompatibility	ISO 10993-1:2018 (including ISO 10993-5, ISO 10993-23, ISO 10993-10, ISO 10993-11)	Demonstrates substantial equivalence with the predicate device regarding biological safety.
	- Cytotoxicity Test	Passed
	- Irritation Test (Oral mucosa)	Passed
	- Sensitization Test	Passed
	- Systemic Toxicity Test	Passed
Cleaning Process Validation	ISO 11737-1:2018, ISO/TS 17665-2: 2009	Confirmed effective in terms of cleaning effect (Physicochemical tests, cleaning agent residual test, residual on evaporation test, microbial test, drying validation tests performed). Worst-case sample evaluated.

Explanation for Missing AI/ML-Specific Information:

Since this submission is for a physical medical device (a protective cap for dental implants) and not an AI/ML software device, the following points are not discussed in the document:

Sample size for test set and data provenance: No test sets of data were used in the AI/ML sense. Physical samples of the device were used for sterilization, biocompatibility, and cleaning validation.
Number of experts and their qualifications for ground truth: No ground truth establishment by experts for AI/ML performance was required.
Adjudication method: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. There is no human reader component that would be "augmented" by an AI.
Standalone (algorithm-only) performance: Not applicable, as there is no algorithm.
Type of ground truth used: For physical device testing, the "ground truth" is adherence to established engineering and medical standards (e.g., successful sterilization, non-toxic, effectively cleaned).
Sample size for training set: Not applicable, as there is no AI model to train.
How ground truth for training set was established: Not applicable.

The document concludes that the Protective Cap is substantially equivalent to its predicate device based on these non-clinical tests, sharing the same intended use, material, functions, principle of operation, sterilization method, and similar designs and dimensions, with differences not affecting fundamental function.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

April 30, 2024

Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620

Re: K232528

Trade/Device Name: Protective Cap Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 7, 2024 Received: April 8, 2024

Dear April Lee:

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 (the 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 available 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}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Sherrill Lathrop Blitzer

{2}------------------------------------------------

for Andrew Steen 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

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K232528

Device Name Protective Cap

Indications for Use (Describe)

Protective Cap is intended for use with a dental implant to prosthetic restorations such as crowns, bridges, or overdenture, and can be used for a minimum of 1 day to maximum of 10 days.

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."

{4}------------------------------------------------

510(k) Summary

Submitter

Neobiotech Co., Ltd. Yoeng Ku, Hoe 70, Sinpyeong-ro, Jijeong-myeon Wonju-si, Gangwon-do, Republic of Korea Email: jihee.baek@neobiotech.com Tel. +82-33-742-2885 Fax. +82-33-742-2887

Device Information

Trade Name: Protective Cap ●
Common Name: Endosseous Dental Implant Abutment
Classification Name: Abutment, Implant, Dental, Endosseous
Product Code: NHA
Panel: Dental ●
. Regulation Number: 21 CFR 872.3630
Device Class: Class II ●
. Date Prepared: 04/25/2024

Predicate Devices:

Primary Predicate

K161689, OSSTEM Implant System-Abutment by Osstem Implant Co.,Ltd.

Indications for Use:

Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

{5}------------------------------------------------

Device Description

The dimensions of abutments are as following:

Name	Type	Diameter (Ø)	Length(mm)	Material
Protective Cap	IS	Ø 5.0/5.7/6.2/7.0	5.7/7.2/7.65/8.7	Polycarbonate(ASTM F997)
	IT	Ø 5.45/6.0/7.2/7.7	5.35/5.9/6.85/7.4/7.65/8.35/8.9

The tolerance of dimension shall be within ± 1% range.

The Protective Cap is compatible with Solid Abutment and Cemented Abutment in previously cleared system as below:

Compatible Type	K number	Abutment Name	Diameter (Ø)	Length of Cuff(mm)
Protective Cap forIS Type	K181138	IS Solid Abutment	4.5/5.2/5.7/6.5	4.0/4.5/5.5/7.0
		IS Cemented Abutment	4.5/5.2/5.7/6.5	4.0/4.5/5.5/7.0/8.0
Protective Cap forIT Type	K181137	IT Solid Abutment	3.5/4.3	4.0/5.5/7.0
		IT Excellent SolidAbutment	4.35	5.25/6.75
		IT Cemented Abutment	4.3/4.85/5.5/6.55	5.8/6.0

{6}------------------------------------------------

Summaries of Technological Characteristics:

	Subject Device	Primary Device
Company	Neobiotech Co., Ltd	OSSTEM Implant Co., Ltd.
Device Name	Protective Cap	OSSTEM Implant System - Abutment
Abutment Name	Protective Cap	Rigid Protect Cap
510(k) Number	K232528	K161689
Product Code	NHA	NHA
Indications for Use	Protective Cap is intended for use with a dentalimplant to provide support for prostheticrestorations such as crowns, bridges, oroverdenture, and can be used for a minimum of1 day to maximum of 10 days.	OSSTEM Implant System - Abutment isintended for use with a dental implant toprovide support for prosthetic restorations suchas crowns, bridges, or overdentures.
Material	PC(Polycarbonate)	PC (PolyCarbonate)
Design
Dimensions	IS: Ø 5.0/5.7/6.2/7.0 X 5.7/7.2/8.7/7.65mm	Ø4.4/5.0/5.5/6.6/7.4 X5.5/5.7/5.8/5.9/7.0/7.2/7.3/8.5/8.7/8.8 mm
	IT: Ø 5.45/7.2/6.0/7.7X 5.9/7.4/8.9/5.35/6.85/8.35/7.65mm
Sterilization	User Steam Sterilization	User Steam Sterilization
Similarities	The subject device has the same intended use, material, functions, principle of operation,sterilization, similar designs, and dimensions.
Differences	There are slightly different designs and dimensions. These differences do not affect product'sfundamental function and the subject device is used temporarily; therefore, it is substantialequivalent.

Non-clinical testing data:

The subject device was tested to evaluate its substantial equivalence according to the following standards.

End User Sterilization Validation Testing according to ANSI/AAMI ST79, ISO 17665-1, ISO ● 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1
Biocompatibility Testing according to ISO 10993-1:2018 ●
- Cytotoxicity tested according to ISO 10993-5: 2009 o
- Irritation tested according to ISO 10993-23:2021 O
- O Sensitization tested according to ISO 10993-10:2021
- Systemic Toxicity tested according to ISO 10993-11:2017 O
Cleaning Process Validation Testing according to ISO 11737-1:2018, ISO/TS 17665-2: 2009 ●

For all subject devices delivered non-sterile to be end-user sterilized, the recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling, issued on March 17, 2015". The worst-case construct was tested.

The Biocompatibility test was conducted on the subject device. We evaluated a biological test in accordance with ISO 10993-1:2018, total of 4 tests were performed: "cytotoxicity", "sensitization", "Oral mucosa irritation", and "systemic toxicity". It demonstrates that the subject device is substantially

{7}------------------------------------------------

equivalent with the predicate device.

Cleaning Process Validation test was evaluated on the worst case sample. Physiochemical test(TOC, pH, electrical conductivity test) and cleaning agent residual test (HPLC), residual on evaporation test, microbial test (Bioburden test) and drying validation tests were conducted. Through these tests, it was confirmed that is effective in terms of cleaning effect.

Clinical testing was not necessary to establish substantial equivalency of the device.

Conclusion

Protective Cap constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, Protective Cap and its predicate are substantially equivalent.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)