The NB 1 SA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB 1 SA Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

Device Description

The NB 1 SA Implant System is composed of ARUM NB 1 SA Fixture, ARUM NB Cover Screw, ARUM NB Healing Abutment, ARUM Cemented Abutment (Hex, Non-Hex), and Abutment screw. ARUM NB 1 SA Fixture is a thread type implant body made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. The surface of the fixture is treated with SLA (Sandblasted with Large grit and Acid-etching). The fixture is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity and it is connected with dental prostheses.

AI/ML Overview

The document provided is a 510(k) Premarket Notification for the NB 1 SA Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical test data, rather than reporting on a specific study that evaluates device performance against acceptance criteria in a clinical setting.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, and MRMC studies are not present in this document. The information provided heavily relies on non-clinical tests to support the substantial equivalence claim.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are largely linked to meeting the requirements of specific ISO and ASTM standards for non-clinical testing. The "reported device performance" is that the results of these tests "met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."

Test Type	Acceptance Criteria	Reported Device Performance
For Devices Delivered Sterile (Fixture & Cover Screw)
Gamma Sterilization Validation Test	Sterility Assurance Level (SAL) of 10^-6 (according to ISO 11137-1:2006)	Met the criteria of ISO 11137-1:2006; SAL of 10^-6 validated.
Shelf-Life Test	Equivalence to predicate devices (according to ASTM F1980)	Met the criteria of ASTM F1980; worst-case construct tested, results demonstrated equivalence to predicate. Shelf life for devices provided sterile is 5 years.
Biocompatibility Testing	Compliance with ISO 10993-1:2009, -3:2014, -5:2009, -6:2007, -10:2010, -11:2006 (for fixtures)	Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance.
LAL Endotoxin Testing	Compliance with AAMI / ANSI ST72:2011/(R)2016	Met the criteria of the standards and demonstrated substantial equivalence with the predicate device.
Non-Pyrogenic Claim (NB 1 SA Fixture)	Not applicable	Devices will not be marketed as non-pyrogenic.
For TiN Coating Abutments
Biocompatibility Testing	Compliance with ISO 10993-1:2009, -5:2009, -10:2010	Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance.
For Devices Delivered Non-Sterilized (Abutments)
End User Sterilization Validation Test	Compliance with ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, ISO 11138-1 and FDA guidance	Recommended sterilization validated according to ISO 17665-1 and ISO 17665-2 and applicable FDA guidance. Worst-case construct tested, results demonstrated equivalence to predicate device.
Biocompatibility Testing (Ti-6Al-4V ELI)	Compliance with ISO 10993-1:2009, -3:2014, -5:2009, -6:2007, -10:2010, -11:2006	Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance.
Surface Modification Information (Fixtures)	Provided (roughness, composition, SEM with SLA)	Surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided. (Results not explicitly detailed as acceptance criteria).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the document. The testing described is primarily non-clinical (sterilization, shelf-life, biocompatibility, LAL endotoxin, material characteristics).
Data Provenance: Not explicitly stated as "country of origin for data." The submitter is Arumdentistry Co., Ltd. from Daejeon, Republic of Korea. The testing itself is non-clinical and conducted in vitro or ex vivo (e.g., material testing, microbial inactivation). The document does not describe human subject data.
Retrospective or Prospective: Not applicable as the described tests are non-clinical hardware tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for the non-clinical tests is established by the specified international standards and guidelines (e.g., ISO, ASTM, AAMI/ANSI). No human expert "ground truth" derived from clinical data is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The described tests are non-clinical and do not involve adjudication by experts in the context of diagnostic interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is mentioned. The device is an endosseous dental implant system, not an AI-powered diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable to the device described. The NB 1 SA Implant System is a physical dental implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by the technical specifications and performance requirements established in the referenced international standards (e.g., SAL of 10^-6 for sterility, specific material properties, successful validation of sterilization cycles, biocompatibility under ISO guidelines, etc.). No clinical ground truth (like pathology or outcomes data) is discussed for this 510(k).

8. The sample size for the training set

Not applicable. This document describes non-clinical testing of a physical medical device, not a machine learning algorithm that requires training data.

9. How the ground truth for the training set was established

Not applicable, as no training set is mentioned or relevant to the device described.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

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

Re: K213506

Trade/Device Name: NB 1 SA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 4, 2022 Received: March 7, 2022

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 (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 medical devices and radiation-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.

Andrew I. 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K213506

Device Name NB 1 SA Implant System

Indications for Use (Describe)

The NB 1 SA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB 1 SA Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

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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510(K) Summary

Submitter

Arumdentistry Co., Ltd. Hyang Mi Lee 1-dong, 44, Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea Email: arum ra@arumdentistry.com Tel. +82-42-935-3644 Fax. +82-42-935-3633

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

Device Information

Trade Name: NB 1 SA Implant System ●
Common Name: Endosseous Dental Implant
Classification Name: Implant, Endosseous, Root-Form ●
Primary Product Code: DZE
Secondary Product Code: NHA
Panel: Dental
. Regulation Number: 21 CFR 872.3640
Device Class: Class II
. Date Prepared: 04/06/2022

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

Primary Predicate

. K181138, IS-III active System by Neobiotech Co., Ltd.

Reference Device

. K150060, J2A Dental Implant System manufactured by KJ Meditech Co., Ltd.
K172100, URIS Implant System by Truabutment Inc. ●
K193425, Pre-Milled Blank by Arumdentistry Co., Ltd.

Indication for Use:

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Device Description:

The surface of the fixture is treated with SLA (Sandblasted with Large grit and Acid-etching). The fixture is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity and it is connected with dental prostheses.

No.	Device Name	Dimension Ranges
1	ARUM NB 1 SA Fixture	Ø 3.8 (D) x 8.5, 10, 11.5, and 13 mm (L)
		Ø 4.0, 4.5, 5.0 (D) x 7.0, 8.5, 10, 11.5, and 13 mm (L)
		Ø 5.5, 6.0, 6.5 (D) x 7.0, 8.5, 10, 11.5, and 13 mm (L)
2	ARUM NB Cover Screw	Ø 3.6 (D) x 5.3, 6, 7, 8 mm (L)
3	ARUM NB Healing Abutment	Ø 4.2, 4.7, 5.7, 6.7, 7.7 (D) x 1.0, 2.0, 3.0, 4.0mm(CuffHeight)
4	ARUM Cemented Abutment_Hex	Ø 4.5, 5.5, 6.5 (D) x 5.0, 5.5, 7.0 mm (Post Height)
	ARUM Cemented Abutment_Non Hex	Ø 4.5, 5.5, 6.5 (D) x 5.0, 5.5, 7.0 mm (Post Height)
5	Abutment Screw	Ø 2.35 (D) x 8.4 mm(L)

The dimensions of the subject device are as following:

Tolerance of dimension shall be within ± 1% range.

The Abutments have below featured:

Name	Uses	Surface	Connection
ARUM NB CoverScrew	It is used for protecting inner hole and connectingpart with exposed upper part of structure duringthe healing period after inserting dental implantfixture	Non	ScrewRetained
ARUM NB HealingAbutment	Used to formation appropriate gingival shapeduring the soft tissue healing period combinedwith implant	Non	ScrewRetained
ARUM CementedAbutment	The Abutment is connected with fixture and itsupports prosthesis which restores tooth function.	TiN Coating	InternalHex, Non-hex
Abutment Screw	Abutment Screw is used to connect an abutmentto the fixture.	Non	ScrewRetained

ARUM NB 1 SA Fixture and ARUM NB Cover Screw are provided sterilized. And the other Abutments are provided non-sterilized.

ARUM NB 1 SA Fixture is enclosed with ARUM NB Cover Screw in a packing. ARUM Cemented abutment is enclosed with Abutment Screw in a packing.

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Materials:

The fixtures are fabricated from Pure titanium of ASTM F67 ●
ARUM Cemented abutment, abutment screw, Healing Abutment, and cover screw are fabricated from . Ti-6Al-4V of ASTM F136

Summaries of Technological Characteristics & Substantial Equivalence Discussion

	Subject Device	Primary Predicate	Reference Device
Company	ARUMDENTISTRY Co., Ltd.	Neobiotech Co., Ltd	KJ Meditech Co., Ltd.
Device Name	NB 1 SA Implant System	IS-III active System	J2A Dental Implant System
510(k) Number	K213506	K181138	K150060
DeviceClassification	Implant, Endosseous,Root-Form	Implant, Endosseous,Root-Form	Implant, Endosseous,Root-Form
Product Code	DZE	DZE	DZE
RegulationNumber	872.3640	872.3640	872.3640
Indications forUse	The NB 1 SA Implant Systemis indicated for use in partiallyor fully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutmentsupport for fixed bridgework.NB 1 SA Implant System isdedicated for two stagesurgical procedures and forimmediate loading when thereis good primary stability andan appropriate occlusal load.Also, implants with diameterslarger than 5mm are indicatedfor molar regions.	The IS-III active System isindicated for use in partiallyor fully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutmentsupport for fixed bridgework.IS-III active System isdedicated for two stagesurgical procedures and forimmediate loading when thereis good primary stability andan appropriate occlusal load.Also, implants with diameterslarger than 5mm are indicatedfor molar regions.	The J2A Dental ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple-unit restorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutmentsupport for fixed bridgework.The J2A Dental ImplantSystem is for single and twostage surgical procedures. Thesystem is intended for delayedloading.
Material	TI CP4 of ASTM F67	TI CP4 of ASTM F67	Ti-6Al-4V ELI of ASTMF136
Design	Image: Design of NB 1 SA Implant System	Image: Design of IS-III active System	Image: Design of J2A Dental Implant System
Anti-RotationalFeature	Internal Hex	Internal Hex	Internal Hex
Diameters( $\varnothing$ )	3.8/4.0/4.5/5.0/5.5/6.0/6.5	3.5/4.0/4.5/5.0/5.5/6.0/7.0	3.75/4.0/4.3/4.5/5.0/5.5/6.0
Lengths(mm)	7.0/ 8.5/ 10/ 11.5/ 13.0	7.3/8.5/10.0/11.5/13.0/15.0	7.0/8.5/10.0/11.5/13.0/15.0
SurfaceTreatment	SLA	SLA	RBM
Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization
Principle ofOperation	This product is a root-typefixture which is inserted in thealveolar bone. It replaces thefunctions of the missing teethas a dental implant fixture.	This product is a root-typefixture which is inserted in thealveolar bone. It replaces thefunctions of the missing teethas a dental implant fixture.	This product is a root-typefixture which is inserted in thealveolar bone. It replaces thefunctions of the missing teethas a dental implant fixture.
Similarities	The NB 1 SA Implant System has same device characteristics with the Primary predicate device,IS-III active System(K181138) such as intended use, material, functions, surface treatment,general shape (Design), structure, anti-rotational feature, principle operation and appliedproduction method.
Differences	The differences between the subject device and the primary predicate device are the productdesign and dimensional range. The design difference doesn't affect product's fundamentalfunction. To support the dimensional differences such as fixture with Ø4.0 X 7.0mm, we selectedK 150060 as the reference device, which covers the subject device's dimensional range.Therefore, it is substantially equivalent.

1) ARUM NB 1 SA Fixture

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2) ARUM NB Cover Screw

	Subject Device	Primary Predicate
Company	ARUMDENTISTRY Co., Ltd.	Neobiotech Co., Ltd
Device Name	NB 1 SA Implant System	IS-III active System
510(k) Number	K213506	K181138
Material	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136
Design	Image: Implant design 1	Image: Implant design 2
Diameters(Ø)	3.6	3.45/3.6
Lengths(mm)	5.3, 6, 7, 8 mm (L)	5.85/6.85/7.45/6.4/7.4/8.0/
Surface Treatment	Non-Anodizing	Anodizing/ Non-Anodizing,
Sterilization	Gamma Sterilization	Gamma Sterilization
Principle of Operation	It is used for protecting inner hole and connecting part with exposed upper part of structure during the healing period after inserting dental implant fixture. When inserting the Abutment, Cover screw is removed.	It is used for protecting inner hole and connecting part with exposed upper part of structure during the healing period after inserting dental implant fixture. When inserting the Abutment, Cover screw is removed.
Similarities	The subject device has same intended use, material, functions, principle of operation, shelf life and similar design and dimensions.
Differences	There are slightly different designs and dimension. These differences do not affect product's fundamental function; therefore, it is substantial equivalent.

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	Subject Device	Primary Predicate	Reference Device
Company	ARUMDENTISTRY Co.,Ltd.	Neobiotech Co., Ltd	TruAbutment Korea Co.,Ltd.
Device Name	NB 1 SA Implant System	IS-III active System	URIS OMNI System
510(k) Number	K213506	K181138	K172100
Material	Ti-6Al-4V ELI of ASTMF136	Ti-6Al-4V ELI of ASTMF136	Ti-6Al-4V ELI (ASTMF136)
Design	Image: design	Image: design	Image: design
Diameters (Ø)	4.2/4.7/5.7/6.7/7.7	4.0/4.5/4.8/5.5/6.0/6.8/8.0/9.0	4.0/4.5/5.5/6.5/7.5mm
Cuff height (mm)	1.0,2.0, 3.0, 4.0mm	2.3/2.8/3.3/3.8/4.3/4.8/5.3/5.8/6.3/6.8/7.8/	1.0mm~5.0mm
SurfaceTreatment	N/A	N/A	Anodizing (Yellow, Green)
Sterilization	Non-sterile	Gamma Sterilization	Non-sterile
Principle ofOperation	This product is healingAbutment to formationappropriate gingival shapeduring the soft tissue healingperiod combined withimplant. This product shouldbe removed when thesuperstructure is set up.	This product is healingAbutment to formationappropriate gingival shapeduring the soft tissue healingperiod combined withimplant. This product shouldbe removed when thesuperstructure is set up.	This product is healingAbutment to formationappropriate gingival shapeduring the soft tissue healingperiod combined withimplant. This product shouldbe removed when thesuperstructure is set up.
Similarities	The subject device has same intended use, material, functions, principle of operation, andsimilar design and dimensions.
Differences	The differences between the subject device and the primary predicate device are thesterilization, dimensions and design. To support the difference of the sterilization, K172100was added and the differences of design and dimensions do not affect product's fundamentalfunction, therefore, it is substantially equivalent.

3) ARUM NB Healing Abutment

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	Subject Device		Primary Predicate Device
Company	ARUMDENTISTRY Co., Ltd.		Neobiotech Co., Ltd
Device Name	NB 1 SA Implant System		IS-III active System
510(k) Number	K213506		K181138
Material	Ti-6Al-4V ELI of ASTM F136		Ti-6Al-4V ELI of ASTM F136
Design	Image: dental implant	Image: dental implant	Image: dental implant	Image: dental implant	Image: dental implant
	Hex	Non-Hex	Hex	Non-Hex	SCRP
Diameters (Ø)	4.5 / 5.5 / 6.5		4.5/5.2/5.7/6.5
Post height(mm)	5.0/ 5.5 / 7.0		4.0/4.5/5.5/7.0/8.0
SurfaceTreatment	TiN-Coating		TiN-Coating
Principle ofOperation	It is indicated for screw-retained singletooth or cement retained single tooth andbridge restorations.		It is indicated for screw-retained single tooth or cementretained single tooth and bridge restorations.
Similarities	The subject and primary predicate have same indications for use, functions, materials, surfacetreatment, and general shape (design) as the primary predicate.
Differences	The design of the devices is slightly different, but it doesn't affect device's fundamental functions;therefore, it is substantial equivalent.

4) ARUM Cemented Abutment

5) Abutment Screw

	Subject Device	Primary Predicate
Company	ARUMDENTISTRY Co., Ltd.	Neobiotech Co., Ltd
Device Name	NB 1 SA Implant System	IS-III active System
510(k) Number	K213506	K181138
Material	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136
Design	Image: Screw	Image: Two screws
Diameters (Ø)	2.35	2.3
Length (mm)	8.4	8.8/8.3
Surface Treatment	N/A	N/A
Principle of Operation	This product is a screw for connectedwith Abutment and fixture.	This product is a screw for connected withAbutment and fixture.
Similarities	The subject and primary predicate have same indications for use, functions, materials,surface treatment, general shape (design) and diameters.
Differences	The design of the devices is slightly different, but it doesn't affect device's fundamentalfunctions; therefore, it is substantial equivalent.

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Non-Clinical Test Data

Below tests were performed on subject device:

. Gamma Sterilization Validation Test on Fixtures according to ISO 11137-1.2.3
. Shelf-Life Test on Fixtures according to ASTM F1980
. Biocompatibility testing on fixtures according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006
. Biocompatibility testing on TiN Coating Abutments according to ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010
. LAL endotoxin testing according to AAMI / ANSI ST72:2011/(R)2016

Below tests were performed for predicate device, K193425 and leveraged for the subject device:

End User Sterilization Validation Test Report on Abutments according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1 referenced in K193425
Biocompatibility testing on Abutments made with Ti-6Al-4V ELI according to ISO 10993-. 1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K193425

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.

The surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided.

For devices delivered sterile (ARUM NB 1 SA Fixture and Cover Screw) - a sterility assurance level (SAL) of 106 have been validated in accordance with ISO 11137-1:2006. Sterilization of health care products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

Shelf Life Testing was performed in accordance with ASTM F1980, Standard Guide for Accelerated Aging of Sterile Medical Device Packages. The worst-case construct was tested, and results demonstrated equivalence to the predicate devices. The shelf life for devices provided sterile is 5 years. The devices will not be marketed as non-pyrogenic.

For all other subject devices delivered non-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 Settings: Validation Methods and Labeling, issued on March 17, 2015". The worst-case construct was tested, and results demonstrated equivalence to the predicate device.

Biocompatibility Testing was performed according to ISO 10993-1:2009. "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and to the FDA Guidance document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff", Document issued on: June 16, 2016", for each of the subject devices.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

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Conclusion

The documentation submitted in this premarket notification demonstrates the NB 1 SA Implant System is substantially equivalent to the primary predicate and reference devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.