The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

· Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
· DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
· Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

Device Description

The TruAbutment DS system includes custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:

(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the custom abutments take into consideration the shape of final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

The proposed abutments are available in internal hex connection, and are compatible with Biomet 3i Certain® Implant/DIO UF(II) Internal Submerged Implant/Megagen AnyRidge® Implant/Neoss ProActive® Implant.

AI/ML Overview

The device being discussed is "TruAbutment DS", a patient-specific CAD/CAM abutment for dental implants.

The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (TruAbutment DS K170259) through non-clinical testing, primarily mechanical performance (fatigue) testing, and biocompatibility assessments. The study described focuses on non-clinical testing to meet these acceptance criteria rather than a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by Standards & Guidance)	Reported Device Performance (as demonstrated by testing)	Equivalence Discussion
Mechanical Performance: Meets ISO 14801:2007 (dynamic fatigue with static compression) and FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" to demonstrate sufficient strength for intended use.	Comparative fatigue testing conducted according to ISO 14801 and FDA Guidance. Worst-case constructs (smallest diameter with maximum angulation) were subjected to static compression and compression fatigue. The fatigue limit data for all implant lines demonstrated the construct strengths to be sufficient for their intended use.	Equivalent. The testing demonstrated implant to abutment compatibility and established substantial equivalency.
Material Biocompatibility: Meets ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.	Biocompatibility tests performed according to ISO 10993 series. Results met the standards.	Equivalent. No concerns regarding material.
End User Steam Sterilization: Meets ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.	End User Steam Sterilization Test performed according to specified ISO and ANSI/AAMI standards.	Equivalent. Confirmed sterility methods for end-user.
Dimensional Compatibility: Demonstrates compatibility with specified OEM implant systems (Biomet 3i Certain®, DIO UF(II) Internal Submerged, Megagen AnyRidge®, Neoss ProActive®).	Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, assessing maximum/minimum dimensions, tolerances, and cross-sectional images of the submission device and compatible implants.	Equivalent. Demonstrated implant to abutment compatibility. Minor differences in compatible OEM implant lines are mitigated by mechanical testing.

2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample size (number of abutments or implants) used for the non-clinical mechanical and dimensional tests. It mentions "worst-case constructs" for fatigue testing.
Data provenance: The testing was conducted by the manufacturer (TruAbutment Inc.) as part of their 510(k) submission to the FDA, presumably in the USA (where the company is based). The data is retrospective as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this device's performance is established by meeting recognized international and national standards (ISO, FDA guidance) through non-clinical laboratory testing, not by expert consensus on clinical cases.

4. Adjudication method for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of medical images. The studies performed for this device were non-clinical laboratory tests.

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, an MRMC comparative effectiveness study was not done. This device is a physical dental implant abutment, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance is assessed by its mechanical integrity and biocompatibility when used as intended.

7. The type of ground truth used
The "ground truth" used for this device is based on established engineering and materials science principles and validated standards:

Mechanical Performance: Defined by the specified fatigue limits and static load capabilities as per ISO 14801 and FDA guidance thresholds for dental implant abutments.
Biocompatibility: Defined by the absence of adverse biological reactions as per ISO 10993 series standards.
Dimensional Accuracy: Defined by precise measurements confirming compatibility with target implant systems.

8. The sample size for the training set
This is not applicable. This device is not an AI model that requires a training set. The CAD/CAM design process for patient-specific abutments involves individual patient data rather than a large training dataset for device development in the AI sense.

9. How the ground truth for the training set was established
This is not applicable as there is no "training set" in the context of an AI device. The design principles for the TruAbutment DS are based on established dental implantology, engineering design, and manufacturing standards for patient-specific CAD/CAM abutments.

Summary

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June 19, 2020

TruAbutment Inc. Chris Choi Director 17742 Cowan Irvine, California 92614

Re: K191913

Trade/Device Name: TruAbutment DS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 19, 2020 Received: May 19, 2020

Dear Chris Choi:

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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K191913

Device Name TruAbutment DS

Indications for Use (Describe)

The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

· Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
· DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
· Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm

The available range of diameters is summarized below:

Biomet 3i Certain® (K130949)

Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal Hex DIO UF(II) Internal Submerged (K161987, K170608, K173975) Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Megagen AnyRidge® (K140091) Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Neoss ProActive® (K083561) Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Submitter

TruAbutment Inc. Kiyoon Nam 17742 Cowan, Irvine, CA 92614 USA Email: kiyoon.nam@truabutment.com Phone: 1-714-956-1488

Official Correspondent

TruAbutment Inc. Chris Choi 17742 Cowan, Irvine, CA 92614 USA Email: chris.choi@truabutment.com Phone: 1-714-956-1488

Device Information

Trade Name: TruAbutment DS,
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: 06/19/2020 .

Predicate Devices/Reference Devices

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

Primary Predicate

TruAbutment DS (K170259) .

Reference Device

TruAbutment DS (K152559) ●
Zimmer® Patient Specific Abutment (K143505) ●
Biomet 3i Certain® (K130949) ●
. DIO UF(II) Internal Submerged (K161987, K170608, K173975)
Megagen AnyRidge® (K140091
Neoss ProActive® (K083561) ●

General Description

(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.

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Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.

Implant System	ImplantØ (mm)	ImplantLength (mm)	ModelNumber(mm)	ImplantPlatform (mm)	Type of Implant-AbutmentConnection
Biomet 3iCertain®(K130949)	3.25	8.5	IFNT3285	3.4	Internal Hex
		10	IFNT3210
		11.5	IFNT3211
		13	IFNT3213
		15	IFNT3215
4.0	8.5	IFNT485	4.1
	10	IFNT410
	11.5	IFNT411
	13	IFNT413
	15	IFNT415
5.0	8.5	IFNT585
	10	IFNT510	5.0
	11.5	IFNT511
	13	IFNT513
	15	IFNT515
6.0	8.5	IFNT685		6.0
	10	IFNT610
	11.5	IFNT611
	13	IFNT613
	15	IFNT615
DIO UF(II)InternalSubmergedImplant(K161987)(K170608)(K173975)	3.3	8.5	UF(II)N3308	Narrow(K161987)	Internal Hex
		10	UF(II)N3310
		11.5	UF(II)N3311
		13	UF(II)N3313
		15	UF(II)N3315
	3.8	8.5	UF(II)3808S	Regular(K170608)
	10	UF(II)3810S
		11.5	UF(II)3811S
		13	UF(II)38013
		15	UF(II)38015
		16	UF(II)3816S
Implant System	ImplantØ (mm)	ImplantLength (mm)	ModelNumber(mm)	ImplantPlatform (mm)	Type of Implant-AbutmentConnection
	4.0	7	UF(II)4007S
		8.5	UF(II)4008S
		10	UF(II)4010S
		11.5	UF(II)4011S
		13	UF(II)4013S
		15	UF(II)4015S
		16	UF(II)4016S
	4.5	7	UF(II)4507S
		8.5	UF(II)4508S
		10	UF(II)4510S
		11.5	UF(II)4511S
		13	UF(II)4513S
		15	UF(II)4515S
		16	UF(II)4516S
	5.0	7	UF(II)5007S
		8.5	UF(II)5008S
		10	UF(II)5010S
		11.5	UF(II)5011S
		13	UF(II)5013S
		15	UF(II)5015S
		16	UF(II)5016S
	5.5	7	UF(II)5507S
		8.5	UF(II)5508S
		10	UF(II)5510S
		11.5	UF(II)5511S
		13	UF(II)5513S
		15	UF(II)5515S
		16	UF(II)5516S
	6.0	7	UF(II)6007S
		8.5	UF(II)6008S
		10	UF(II)6010S
		11.5	UF(II)6011S	Wide(K173975)
		13	UF(II)6013S
	6.5	7	UF(II)6507S
		8.5	UF(II)6508S
		10	UF(II)6510S
		11.5	UF(II)6511S
		13	UF(II)6513S
	7.0	7	UF(II)7007S
		8.5	UF(II)7008S
Implant System	Implant Ø (mm)	Implant Length (mm)	Model Number (mm)	Implant Platform (mm)	Type of Implant-Abutment Connection
		10	UF(II)7010S
		11.5	UF(II)7011S
		13	UF(II)7013S
		3.5	8	FANIHX3508
			10	FANIHX3510
			11.5	FANIHX3511
			13	FANIHX3513
		15	FANIHX3515
		18	FANIHX3518
	4.0	8	FANIHX4008
		10	FANIHX4010
		11.5	FANIHX4011
		13	FANIHX4013
		15	FANIHX4015
		18	FANIHX4018
MegagenAnyRidge®(K140091)	4.5	7	FANIHX4508	3.1	Internal Hex
		8	FANIHX4508
		10	FANIHX4510
		11.5	FANIHX4511
		13	FANIHX4513
		15	FANIHX4515
		18	FANIHX4518
	5.0	7	FANIHX5007
		8	FANIHX5008
		10	FANIHX5010
		11.5	FANIHX5011
		13	FANIHX5013
		15	FANIHX5015
		18	FANIHX5018
	5.5	7	FANIHX5507
		8	FANIHX5508
		10	FANIHX5510
		11.5	FANIHX5511
		13	FANIHX5513
		15	FANIHX5515
		18	FANIHX5518
NeossProActive®(K083561)	3.25	9	21176	3.5	Internal Hex
		11	21177
		13	21178
		15	21179
Implant System	ImplantØ (mm)	ImplantLength (mm)	ModelNumber(mm)	ImplantPlatform (mm)	Type of Implant-AbutmentConnection
	3.5	7	21181
		9	21182
		11	21183
		13	21184
		15	21185
		17	21186
	4.0	7	21187
		9	21188
		11	21189
		13	21190
		15	21191
		17	21192
	4.5	7	21193	4.0
		9	21194
		11	21195
		13	21196
		15	21197
		17	21198
	5.0	7	21199
		9	21200
		11	21201
		13	21202
		15	21203
		17	21205
	5.5	9	21206
		11	21207
		13	21208
		15	21211
	6.5	9	21212
		11	21213
		13	21221
		15	21222

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Indication for Use

The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:

· Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
· DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
• Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
· Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm

The available range of diameters is summarized below:

Biomet 3i Certain® (K130949)

Megagen AnvRidge® (K140091)

Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex

Neoss ProActive® (K083561)

Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

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Summary of Technological Characteristics

The subject device is substantially equivalent to the creatingly equivalent in intended use, material and connection interfaces to the implants are identical for each individual diameter and connection type. Companison demonstating Substantial Equivalence follows at the end of this section.

Attributes	Proposed Device	Primary Predicate Device	Equivalence Discussion
Trade Name	TruAbutment DS (K191913)	TruAbutment DS (K170259)
Indications forUse	The TruAbutment DS is a patient-specific CAD/CAM custom abutment,directly connected to endosseous dental implants and is intended for use as anaid in prosthetic rehabilitation. It is compatible with following systems:• Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm• DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0,4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm• Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0mm• Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mmThe available range of diameters is summarized below:Biomet 3i Certain® (K130949)Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal HexDIO UF(II) Internal Submerged (K161987, K170608, K173975)Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal HexMegagen AnyRidge® (K140091)Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal HexNeoss ProActive® (K083561)Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal HexImplant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal HexAll digitally designed abutments and/or coping for use with the TruAbutment DSabutments are intended to be sent to a TruAbutment-validated milling center formanufacture.	The TruAbutment DS is a patient-specific CAD/CAM customabutment, directly connected toendosseous dental implants and isintended for use as an aid inprosthetic rehabilitation. It iscompatible with all diameters ofthe Osstem TS Fixture Systemwhich consists of Mini (2.08mm)and Regular (2.48mm) interfacesizes / Zimmer SV/TSV 3.7, 4.1,4.7, 6.0 mm interface sizesAll digitally designed abutmentsand/or coping for use with theTruAbutment DS abutments areintended to be sent to aTruAbutment-validated millingcenter for manufacture.	EquivalentThe basic indication ofproviding support forprostheses is identical. Thesubject devices arecompatible with the sameCAD/CAM System as theprimary predicate device
Attributes	Proposed Device	Primary Predicate Device	Equivalence Discussion
Trade Name	TruAbutment DS (K191913)	TruAbutment DS (K170259)	Equivalent
Connection	Internal Hex	Internal Hex	Equivalent
Sterility	Packaged Non-sterile	Packaged Non-sterile	Equivalent
Material	Ti-6AI-4V ELI	Ti-6AI-4V ELI	Equivalent
Abutment	0~25	0~25	Equivalent
Dimensions	Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mmDIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8,4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mmMegagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5,8.0 mmNeoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm	Osstem TS Fixture System 3.5, 4.0, 4.5,5.0, 5.5, 6.0, 7.0 mmZimmer SV/TSV 3.7, 4.1. 4.7, 6.0 mm	Slightly differenceThe Indications for Use of thesubject and predicate devicesare identical other than thecompatible implant bodies.
Abutment Seat	Sits on Taper	Sits on Taper	Equivalent
Anatomical	Oral Cavity	Oral Cavity	Equivalent
Construction	Machined	Machined	Equivalent
Type ofRetention	Screw-retained to the implant. The prosthesis can be cement-retained to theabutment.	Screw-retained to the implant. Theprosthesis can be cement-retained tothe abutment.	Equivalent

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Substantial Equivalence Discussion

The subject device is substantially equivalent in indications and design principles to the predicate devices listed above. Provided tables are comparing the Indications for Use and the technological characteristics of the subject device, the primary predicate device.

TruAbutment DS incorporates the same material, indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection, type of retention and technological characteristics as the predicate device. The Indications for Use of the subject and predicate devices are identical other than the compatible implant bodies.

Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines among the subject device, the primary predicate device, and the reference devices do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the compatible OEM implant designs, or are mitigated by the mechanical performance testing.

Mechanical performance testing was performed according to ISO 14801 and FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". For each compatible OEM implant line, worst-case constructs were subjected to static compression and compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use.

Both the predicate and subject devices are intended to be milled into patient-specific abutments using CAD/CAM technology under the manufacturing control of the sponsor. Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate.

Non-clinical Testing

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

Fatigue Test according to ISO 14801:2007
Below tests were performed for predicate device (K152559, K170259) and leveraged for the subject device:
. End User Steam Sterilization Test according to ISO 17665-1:2006. 17665-2:2009 and ANSI/AAMI ST79:2010.
Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-● 10:2010.

Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device. The results of the above tests have met the standard, and demonstrated the substantial equivalence with the predicate device.

Comparative fatigue testing of the subject and predicate devices was conducted in accordance with ISO 14801 and FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fating.

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Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible implant body as well as the OEM implant body, OEM abutment, and OEM fixation screw. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.

Conclusion

The TruAbutment DS 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, TruAbutment DS 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.)