BLT Dental Implant Systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

Device Description

The proposed devices, BLT Dental Implant Systems, are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The proposed devices can also be used for immediate or early implantation following extraction or loss of natural teeth. The proposed device contains dental implant, healing cap and abutment. The dental implant system is available in two types, NC type and RC type.

AI/ML Overview

The request asks for acceptance criteria and details of the study proving these criteria are met. The provided text is a 510(k) Summary for a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of characteristics, rather than a clinical study with detailed acceptance criteria and performance metrics typically found for AI/ML devices. Therefore, much of the requested information (like effect size, ground truth, sample size for training/test sets, expert qualifications, and adjudication methods) is not applicable or unavailable from this document.

However, I can extract information related to the device's performance based on non-clinical testing and the acceptance criteria implicitly defined by compliance with recognized standards and demonstrated equivalence to the predicate device.

Here's the summary based on the provided document:

Acceptance Criteria and Study Details for BLT Dental Implant System (K212364)

The "acceptance criteria" for this device are implicitly defined by its compliance with various ISO and ASTM standards, and its demonstrated substantial equivalence to a legally marketed predicate device (K150388) and several reference devices. The "study" proving these criteria is a series of non-clinical tests and a comparison of technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit via Standards/Equivalence)	Reported Device Performance	Study that Proves this Performance
Mechanical Performance	No significant difference in dynamic fatigue performance compared to predicate device. (Aligned with ISO 14801)	"The test result does not show any significant difference." (between proposed device and predicate)	Mechanical test performed according to FDA guidance and ISO 14801.
Biocompatibility	Materials are biocompatible and do not cause adverse effects. (Aligned with ISO 10993 standards)	"The subject device is as safe... as the legally marketed predicate device..." as materials are identical to previously cleared device (K192274).	Leveraged prior biocompatibility testing for K192274, as materials are identical in formulation, processing, and sterilization. Formal compliance with ISO 10993-1, -5, -10, -11 mentioned.
Sterilization	Achieves a Sterility Assurance Level (SAL) of $10^{-6}$. Maintain package integrity. (Aligned with ISO 11137-2)	"Sterilized by irradiation to achieve a SAL of $10^{-6}$." "Vaccuum leak test and sterility test were provided to verify the package integrity."	Sterilization method validated in accordance with ISO 11137-2. Package process is the same as K150388. Complies with ISO 11137-1, ISO 11607-1, -2, ASTM D3078-02(2013), ASTM F88/F88M-15, ASTM F1886/F1886M-16, ASTM F1929-15, ASTM F2096-11.
Material Composition	Complies with relevant material specifications (Titanium alloys).	Made of Pure Titanium (for implant), Titanium Alloy (for abutment/healing cap). Meets ASTM F136-13, ASTM F67-13.	Chemical analysis leveraged from K150388 as surface modification is the same. Test reports for ASTM standards cited.
Bacterial Endotoxin	Meets bacterial endotoxin limits.	"Bacteria endotoxin limit were evaluated for the each lot device."	USP <85> Bacterial Endotoxin Test.
Packaging	Packaging integrity for sterile barrier systems.	Packaging system maintains sterility.	Complies with ISO 11607-1:2019, ISO 11607-2:2019, ASTM D3078-02(2013), ASTM F88/F88M-15, ASTM F1886/F1886M-16, ASTM F1929-15, ASTM F2096-11 (Reapproved 2019), ASTM F1980-07(2011).
Shelf Life	5 years.	5 years.	(Details not explicitly stated in document, but assumed based on predicate equivalence and compliance with accelerated aging standards like ASTM F1980-07(2011) related to packaging.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for specific non-clinical tests. Non-clinical tests like mechanical testing (ISO 14801) typically involve a specific number of samples for destructive testing, but the exact count isn't provided in the summary.
Data Provenance: The tests were conducted by the manufacturer, Bio Concept Co., Ltd. and leverage data from previously cleared devices where materials or processes are identical. The document does not specify the country of origin of the raw test data (e.g., where the mechanical tests were physically performed) beyond the manufacturer's location in China. The data is retrospective in the sense that prior clearance data (K192274, K150388) is referenced for aspects like biocompatibility and surface analysis.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as this is a non-clinical submission for a physical medical device (dental implant system), not an AI/ML device relying on expert-annotated ground truth. The "ground truth" for non-clinical tests comes from physical measurements against established standards.

4. Adjudication Method for the Test Set

Not applicable as this is a non-clinical submission for a physical medical device.

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

Not applicable. This device is a physical dental implant system, not an AI/ML device, so no MRMC study was performed.

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

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for establishing device performance in this context is derived from:
- Scientific Standards: Compliance with recognized international and national standards (ISO 14801 for mechanical properties, ISO 10993 for biocompatibility, ISO 11137-2 for sterilization, ASTM standards for materials and packaging).
- Predicate Device Equivalence: Direct comparison of technological characteristics, materials, and intended use to an existing legally marketed device (K150388) and numerous reference devices.
- Laboratory Testing: Results from mechanical tests, sterilization validation, bacterial endotoxin tests, and packaging integrity tests.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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 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.

Bio Concept Co., Ltd % Diana Hong General Managr Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K212364

Trade/Device Name: BTL Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 13, 2022 Received: July 11, 2022

Dear Diana Hong:

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K212364

Device Name

BLT Dental Implant System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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Tab # 6 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: _K212364

1. Date of Preparation: 08/09/2022
1. Sponsor Identification

BIO CONCEPT CO., LTD

Unit C, No.26, Huashan Middle Road, Xinbei Zone, Changzhou, Jiangsu 213022, China Establishment Registration Number: 3012465917

Contact Person: Tianshui Li Position: General Manager Tel: +86-519-85172266 Fax: +86-519-85172299 Email: daixiaodong(@bioconcept.cn

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: BLT Dental Implant System Common Name: Endosseous dental implant

Regulatory Information Classification Name: Endosseous implant Classification: II Regulation Number: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA Review Panel: Dental

Indications for Use

Device Description

The proposed device contains dental implant, healing cap and abutment. The dental implant system is available in two types, NC type and RC type.

Ref	Name	Type	Diameter	Length
115010	Implant	NC	Φ3.38±0.1	8.1±0.2
115020	Implant	NC	Φ3.38±0.1	10.1±0.2
115030	Implant	NC	Φ3.38±0.1	12.1±0.2

Table 1. Body Size of Dental Implants (Unit: mm)

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115040	Implant	NC	$Φ3.38±0.1$	14.1±0.2
115050	Implant	NC	$Φ3.38±0.1$	16.1±0.2
115060	Implant	NC	$Φ3.38±0.1$	18.1±0.2
116010	Implant	RC	$Φ4.15±0.1$	8.2±0.2
116020	Implant	RC	$Φ4.15±0.1$	10.2±0.2
116030	Implant	RC	$Φ4.15±0.1$	12.2±0.2
116040	Implant	RC	$Φ4.15±0.1$	14.2±0.2
116050	Implant	RC	$Φ4.15±0.1$	16.2±0.2
116060	Implant	RC	$Φ4.15±0.1$	18.2±0.2
117010	Implant	RC	$Φ4.8±0.1$	8.2±0.2
117020	Implant	RC	$Φ4.8±0.1$	10.2±0.2
117030	Implant	RC	$Φ4.8±0.1$	12.2±0.2
117040	Implant	RC	$Φ4.8±0.1$	14.2±0.2
117050	Implant	RC	$Φ4.8±0.1$	16.2±0.2
117060	Implant	RC	$Φ4.8±0.1$	18.2±0.2

The healing cap can be divided into closure screw, healing abutment and protective Cap. Abutment can be divided into anatomic abutment, meso abutment, cementable abutment, equator abutment, Screw-retained abutment and coping. And it is available in NC, crown, bridge, A Type and B Type.

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ર. Identification of Predicate Device
510(k) Number: K150388 Product Name: Dental Implant System Manufacturer: BIO CONCEPT CO., LTD.
1. Identification of Reference Devices
  Reference Device 1 510(k) Number: K153758 Device Name: Straumann Bone Level Tapered Implants Manufacturer: INSTITUT STRAUMANN AG

Reference Device 2 510(k) Number: K072071 Device Name: STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS Manufacturer: Institut Straumann AG

Reference Device 3 510(k) Number: K080286 Device Name: CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS Manufacturer: STRAUMANN USA

Reference Device 4 510(k) Number: K093027 Device Name: STRAUMANN RC TEMPORARY ABUTMENTS Manufacturer: STRAUMANN USA

Reference Device 5 510(k) Number: K192401 Device Name: Straumann Screw-Retained Abutments Manufacturer: Straumann USA, LLC

Reference Device 6 510(k) Number: K171757 Device Name: Straumann Screw Retained Abutments Manufacturer: Straumann USA, LLC (On Behalf Of Institut Straumann AG)

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Reference Device 7 510(k) Number: K182091 Device Name: Osstem Abutment System Manufacturer: Osstem Implant Co., Ltd.

Reference Device 8 510(k) Number: K130808 Device Name: STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS Manufacturer: STRAUMANN USA

Reference Device 9 510(k) Number: K071585 Device Name: P.004 HEALING ABUTMENTS AND CLOSURE SCREWS Manufacturer: STRAUMANN USA

Reference Device 10 510(k) Number: K133421 Device Name: STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW Manufacturer: STRAUMANN USA, LLC

Reference Device 11 510(k) Number: K171409 Device Name: OT EQUATOR Manufacturer: Rhein'83 SRL

Reference Device 12 510(k) Number: K161689 Device Name: OSSTEM Implant System - Abutment Manufacturer: OSSTEM IMPLANT Co., Ltd.

Reference Device 13 510(k) Number: K092814 Device Name: STRAUMANN DENTAL ABUTMENTS Manufacturer: STRAUMANN MANUFACTURING, INC.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device and reference devices.

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Mechanical test was performed on both the proposed device and prediate device according to FDA guidance and ISO 14801. The test result does not show any significant difference.

The patient contact materials of the proposed device, BLT Dental Implant System, are identical to the material of BV Dental Implant System as it was cleared in K192274 in 06/18/2020. in formulation, processing and sterilization, and no other chemicals have been added. (e.g., plasticizers, filters, color additives, cleaning agents, mold release agents, etc.). Therefore, new biocompatibility test were not conducted on the proposed device.

The subject dental implant were sterilized by irradiation to achieve a SAL of 106 and the sterilization method was validated in accordance ISO 11137-2. Vacuum leak test and sterility test were provided to verify the package integrity.The package process for the proposed device is same as Dental Implant System as it was cleared in K150388 in 11/12/2015. Therefore, new package integrity test was not conducted on the proposed device. Besides, bacteria endotoxin limit were evaluated for the each lot device.

The modified surface for the proposed device is same as Dental Implant System as it was cleared in K150388 in 11/12/2015 which is also manufactured by the sponsor. Therefore, the chemical analysis of the surface will leverage on the test report performed on the device K150388 instead of performing a new test.

The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro Cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical Devices-Part 10: Test for irritation and skin sensitization
ISO 10993-11:2017, Biological evaluation of medical Devices-Part 11: Test for systemic toxicity
ISO 14801:2016 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants
USP <85> Bacterial Endotoxin Test
ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
ASTM F67-13 (Reapproved 2017), Standard Specification for Unalloyed Titanium for Surgical Implant Applications
ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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A AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
USP <85> Bacterial Endotoxins Test
ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
A ASTM D3078-02(2013) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ISO 11737-2: 2009 Sterilization of edical Devices-Microbiological Methods-Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process.
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
A ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
A ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dve Penetration
ASTM F2096-11 (Reapproved 2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
1. Clinical Test Conclusion

No clinical study is included in this submission.

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9. Summary of Technological characteristics

ITEM	Proposed Device	Predicate Device K150388	Reference Device 1 K153758	Remark
Product Code	DZE	DZE	DZE	Same
Regulation No.	872.3640	872.3640	872.3640	Same
Classification	II	II	II	Same
Indication for use	BLT Dental Implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the	Dental implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. Dental implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components	Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial	Different
	correspondingcomponents(abutments). In cases of fullyedentulous patients, 4 or moreimplants must be used inimmediately loaded cases.	(abutments). In cases of fullyedentulous patients, 4 or moreimplants must be used inimmediately loaded cases.	or full dentures, which areconnected to the implants by thecorresponding elements(abutments).
Surgery type	One or two stage Surgery	One or two stage Surgery	One or two stage Surgery	Same
Structure	- Internal Crossfit connected- Submerged Implant- Tapered body shape- 3 sided cutting edge withself-tapping	- Internal Crossfit connected- Submerged Implant- Straight body shape	- Internal Crossfit connected- Submerged Implant- Straight body shape	Same
Coronal ThreadForm	Constant major and minor threaddiameters (i.e., parallel wall)0.8mm thread pitch	Constant major and minor threaddiameters (i.e., parallel wall)0.8mm thread pitch	Constant major and minor threaddiameters (i.e., parallel wall)0.8mm thread pitch	Same
ApicalThreadForm	Angled major and minor threaddiameters (i.e., tapered wall), withthe major and minor diametershave differing angles such that thedepth increases toward the apicalend of the implant and theaddition of cutting flutes.0.8mm thread pitch	Constant major and minor threaddiameters(i.e., parallel wall)0.8mm thread pitch	Constant major and minor threaddiameters(i.e., parallel wall)0.8mm thread pitch	Different
BodyDiameter (D)	Ø3.3mm, Ø4.1mm, Ø4.8mm	Ø3.3mm, Ø4.1mm, Ø4.8mm	Ø3.3mm, Ø4.1mm, Ø4.8mm	Same
Implant Length	8, 10, 12, 14, 16, 18mm	8, 10, 12, 14mm	18 mm	Different
Materialof	Pure Titanium	Pure Titanium	Titanium zirconium alloy	Different
Fixture
Surface	Sand blasted and acid etched	Sand blasted and acid etched	Sand blasted and acid etched	Same
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile	Same
Shelf life	5 years	5 years	/	Same

Table 2. Characteristic Comparison for Implant

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Different – Indication for Use

The indications for use for the proposed device is the predicated device. In addition, although the description of indications for use for the proposed device is different from that of the reference device K153758, in fact the same. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.

Different - Apical Thread Form

The difference in structure does, in addition, mechanical test has been conducted on the proposed device and predicate device and the test result does not show any significant difference will not affect substantially equivalence on safety and effectiveness.

Different - Implant Length

The implant length range of the proposed device can be cover and reference device K153758. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.

Different - Material of Fixture

The material of fixture of the same as that of the predicated device. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.

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Anatomic Abutment
ITEM	Proposed Device	Reference Device K072071	Reference Device K080286	Remark
Indications for Use	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such as crowns,bridges and overdentures.	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such as crowns,bridges and overdentures.	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such as crowns,bridges and overdentures.	Same
Principle of Operation	Using making for generalcement-type prosthesis.	Using making for generalcement-type prosthesis.	Using making for generalcement-type prosthesis.	Same
Interface Type	Engaging	Engaging	Engaging	Same
Angle	0°, 15°	0°, 15°	0°, 15°	Same
Gingiva Height (mm)	2, 3.5	2, 3.5	2, 3.5	Same
Material	Titanium alloy	Titanium alloy	Titanium alloy	Same
Cementable Abutment
ITEM	Proposed Device	Reference Device K072071	Reference Device K080286	Remark
Indications for Use	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such as crowns,bridges and overdentures.	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such as crowns,bridges and overdentures.	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such as crowns,bridges and overdentures.	Same
Principle of Operation	Using making for generalcement-type prosthesis.	Using making for generalcement-type prosthesis.	Using making for generalcement-type prosthesis.	Same
Interface Type	Engaging	Engaging	Engaging	Same
Gingiva Height (mm)	1.3, 1.35, 2.3, 2.35, 3.3, 3.35	1, 2, 3, 4, 5, 6	1, 2, 3, 4, 5, 6	Different
Material	Titanium alloy	Titanium alloy	Titanium alloy	Same
Temporary Abutment
ITEM	Proposed Device	Reference Device K093027	Reference Device K092814	Remark
Indications for Use	Temporary Abutments areintended for use in Bone LevelDental Implant for temporaryrestorations of single crowns andbridges for up to six months.	The Straumann RC TemporaryAbutments are indicated for usein Straumann RC bone levelimplants for temporaryrestorations of single crowns andbridges for up to six months.	The Straumann NC TemporaryAbutments are indicated for usein Straumann NC Bone LevelImplants for temporaryrestorations of single crowns andbridges for up to six months.	Same
Principle of Operation	Cement retained restoration; usingmaking temporary prosthesis tomaintain aesthetic appearance untilfinal prosthesis is made.	Cement retained restoration;using making temporaryprosthesis to maintain aestheticappearance until final prosthesisis made.	Cement retained restoration;using making temporaryprosthesis to maintain aestheticappearance until final prosthesisis made.	Same
Interface Type	Engaging/Non-engaging	Engaging/Non-engaging	Engaging/Non-engaging	Same
Angle	Straight	Straight	Straight	Same
Diameter (mm)	3.5, 4.5	4.5	3.5	Same
Height (mm)	11	11	11	Same
Material	Titanium alloy	Pure Titanium	Titanium alloy	Different
Screw-retained Abutment
ITEM	Proposed Device	Reference Device K171757		Remark
Indications for Use	Screw Retained Abutments areindicated to be placed into theimplants of the Dental ImplantSystem to provide support forprosthetic reconstructions such ascrowns, bridges and bars. The finalprocessed devices have thepurpose of restoring chewing	Screw Retained Abutments are indicated to be placed into theimplants of the Dental Implant System to provide support forprosthetic reconstructions such as crowns, bridges and bars. Thefinal processed devices have the purpose of restoring chewingfunction. Screw Retained Abutments are indicated for screw-retainedrestorations.		Same
	function. Screw RetainedAbutments are indicated forscrew-retained restorations.
Principle of Operation	Using making for generalscrew-retained prosthesis.	Using making for general screw-retained prosthesis.	Same
Interface Type	Engaging	Engaging	Same
Angle	0°, 17°, 30°	0°, 17°, 30°	Same
Diameter (mm)	3.5, 4.6	3.5, 4.6	Same
Gingiva Height (mm)	1, 1.5, 2.5, 3.5, 4, 4.5, 5.5	1, 2.5, 4, 5.5	Different
Material	Titanium alloy	Titanium alloy	Same
Coping for screw-retained abutment
ITEM	Proposed Device	Reference Device K192401	Remark
Indications for Use	Copings for screw-retainedabutment are intended for use inscrew-retained abutment fortemporary restorations of singlecrowns and bridges for up to sixmonths.	Straumann temporary copings are compatible with Straumann screwretained abutments and are used for temporary restorations of singlecrowns and bridges.	Same
Principle of Operation	Screw retained restoration; usingmaking temporary prosthesisbefore loading final prosthesis byconnected with screw-retainedabutment,	Screw retained restoration; using making temporary prosthesisbefore loading final prosthesis by connected with screw-retainedabutment,	Same
Interface Type	Engaging/Non-engaging	Engaging/Non-engaging	Same
Abutment Connection	Crown, Bridges	Crown, Bridges	Same
Diameter (mm)	3.5, 4.6	3.5, 4.6	Same
Material	Pure Titanium	Titanium alloy	Different

Table 3. Characteristic Comparison of Abutment and healing cap

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Equator Abutment
ITEM	Proposed Device	Reference Device K182091	Remark
Indications for Use	Equator Abutment is intended foruse with a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures.	Equator Abutment is intended for use with a dental implant toprovide support for prosthetic restorations such as crowns, bridges,or overdentures.	Same
Principle of Operation	Using making implant retainedoverdenture at maxilla/mandible.	Using making implant retained overdenture at maxilla/mandible.	Same
Interface Type	Non-engaging	Non-engaging	Same
Diameter (mm)	3.7	3.5, 3.7, 4.1, 4.8, 5.1	Different
Length (mm)	1, 2, 3, 4, 5, 6	1, 2, 3, 4, 5, 6, 7
Material	Titanium alloy	Titanium alloy	Same
Healing abutment
ITEM	Proposed Device	Reference Device K130808	Reference Device K071585	Remark
Indications for Use	Healing abutments are intended foruse with the Bone Level Implantsystem to protect theinnerconfiguration of the implant andmaintain, stabilize and form thesoft tissue during the healingprocess.	Healing abutments are intendedfor use with the StraumannDental implant system (SDIS)to protect theinnerconfiguration of the implant andmaintain, stabilize and form thesoft tissue during the healingprocess.	Healing abutments are intendedfor use with the Straumann P.004Bone Level Implant System toprotect the inner configuration ofthe implant. Healing abutmentshave a secondary function tomaintain, stabilize and form thesoft tissue during the healingprocess.	Same
Principle of Operation	Used to make a soft tissue shapebefore setting up prosthetics.	Used to make a soft tissue shapebefore setting up prosthetics.	Used to make a soft tissue shapebefore setting up prosthetics.	Same
Interface Type	Non-engaging	Non-engaging	Non-engaging	Same
Diameter (mm)	3.3, 3.6, 4.5, 4.8, 5, 6, 6.5	3.3, 3.6, 4.8, 5	4.4, 4.5, 4.7, 5, 6, 6.5, 7	Different
Height (mm)	2, 3.5, 4, 5, 6	2, 3.5, 5, 7	2, 4, 6, 7
Material	Titanium alloy	Titanium alloy	Titanium alloy	Same
Protective Cap
ITEM	Proposed Device	Reference Device K133421		Remark
Indication for use	Protective Caps are intended toprotect the outer configuration ofthe abutment and to maintain andcondition the contours of the softtissue during the healing phase forup to 6 months.	Protective Caps are intended to protect the outer configuration of theabutment and to maintain and condition the contours of the softtissue during the healing phase for up to 6 months.		Same
Principle of Operation	Used to make a soft tissue shapeand protect the outer configurationof the abutment before setting upprosthetics.	Used to make a soft tissue shape and protect the outer configuration of the abutment before setting up prosthetics.		Same
Interface Type	Non-engaging	Non-engaging		Same
Diameter (mm)	3.5, 4.6	3.5, 4.6		Same
Height (mm)	5, 6.5, 8	5, 6.5, 8		Same
Material	Titanium alloy	PEEK+ Titanium alloy		Different
Basal Screw
ITEM	Proposed Device	Reference Device K161689		Remark
Diameter (mm)	2.1, 2.2	2.0, 2.05, 2.2, 2.3, 2.5		Different
Height (mm)	7.85, 7.9	3.35, 5.6, 7.5, 8.35, 9.6, 10.2		Same
Material	Titanium alloy	Titanium alloy		Same
Screw for screw-retained abutment
ITEM	Proposed Device	Reference Device K161689		Remark
Diameter (mm)	2	2.0, 2.05, 2.2, 2.3, 2.5		Different
Height (mm)	7.2, 8.8, 10.3, 11.8	3.35, 5.6, 7.5, 8.35, 9.6, 10.2	Different
Material	Titanium alloy	Titanium alloy	Same
Occlusal Screw
ITEM	Proposed Device	Reference Device K161689	Remark
Diameter (mm)	2.2	2.0, 2.05, 2.2, 2.3, 2.5	Different
Height (mm)	3.65	3.35, 5.6, 7.5, 8.35, 9.6, 10.2	Different
Material	Titanium alloy	Titanium alloy	Same

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Different - Gingiva Height of Cementable Abutment

The gingiva heigh range of the proposed cementable abutment is different from reference device. However, the proposed specifications can be covered by the reference device K072071 and reference device K080286. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.

Different - Material of Temporary Abutment

The naterial of proposed temporary abutment of the same as that of the reference K092814. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.

Different-Gingiva Height of Screw-retained Abutment

The gingiva height for the proposed Screw reading different from reference device K171757. However, the proposed specifications an be covered by the reference device. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.

Different - Material of Coping for screw-retained abutment

The material of the proposed coping for screw-etained abutment is different from the reference device K192401. However, the biocompatibility evaluation was performed on the result demonstrate that this material does not cause any adverse effects. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.

Different - Diameter and Length of Equator Abutment

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The diameter and length specification for the proposed equator abuter the nover, the proposed specifications an be covered by the reference device K182091. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.

Different - Diameter and Height of Healing abutment

The diameter and height of the proposed healing abutment is different from reference device. However, the proposed specifications can be overed by the reference device K130808 and K071585. Therefore, this difference will not affect substantially equivalence on safety and effectiveness.

Different - Material of Protective Cap

The material of the proposed protective cap is different from the biocompatibility evaluation was performed on the proposed device and the result demonstrate that this material does not cause any adverse this difference will not aftect substantially equivalence on safety and effectiveness.

Different - Diameter and Height of Basal Screw

The diameter and height of the proposed Basal Screw is different from the reference device K161689. However, the proposed diameter and length can be covered in the range of reference device K161689. Therefore, this difference will not affectiveness.

Different - Diameter of Screw for screw-retained abutment

The diameter of the proposed Screw for screw-retained abutment is different from the reference device K16 (689) However, the proposed diameter can be covered in the range of reference device K161689. Therefore, this difference will not affectiveness.

Different - Height of Screw for screw-retained abutment

The height of the proposed Screw for screw-retained abutment is different from the reference device of the proposed device of 7.2mm. 8.8mm and 10.3mm can be covered in the range of reference device K161689. Besides, the provides an additional 1.8mm height which provide more options for physician to select an appropriate device per patients' condition. This diffect intended use. Therefore, this difference will not affect the safety and effectiveness.

Different - Diameter and Height of Occlusal Screw

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The diameter and height of the proposed Occlusal Screw is different from the reference device K161689. However, the proposed diameter and length can be covered in the range of reference device K161689. Therefore, this difference will not affectiveness of the proposed device.

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ITEM	Proposed Device	Predicate Device K150388	Remark
Material
Dental Implant	Pure Titanium	Pure Titanium	Same
Abutment	Titanium Alloy	Titanium Alloy	Same
Healing Cap	Titanium Alloy	Titanium Alloy	Same
Surgical Instrument	Stainless Steel	Stainless Steel	Same
Sterilization
Dental Implant	Gamma Irradiation	Gamma Irradiation
Attachment	Non-sterile	Non-sterile	Same
Surgical Instrument	Non-sterile	Non-sterile
Biocompatibility
Dental Implant	Comply with ISO 10993 standards	Comply with ISO 10993 standards	Same
Instrument	Comply with ISO 10993 standards	Comply with ISO 10993 standards	Same

Material		Biocompatibility
Titanium		Good
Stainless steel		Good
Alumina		Excellent
Zirconia		Excellent
Polymers	PMMA	Fair
	UHMWPE	Good
Composites	Carbon fiber reinforced polymer	Fair
	Hydroxyapatite	Excellent

10. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K150388 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.