NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.

Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Nobel Active TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible.

NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only.

NobelReplace CC TiUltra

NobelReplace CC Tilltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function.

The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelParallel CC TiUltra

NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.

NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with < 7 mm length are for delayed loading only when appropriate stability has been achieved.

MUA Xeal

The MUA Xeal is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

On1 Base Xeal

The On1 Base Xeal device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base Xeal, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

Device Description

The TiUltra implants and Xeal abutments are endosseous dental implants and abutments with an internal conical connection (CC) with hex interface. The TiUltra implants are comprised of three implant lines with various body shapes, range of diameters (3.0 - 5.5mm), and lengths (6.5 -18mm). The Xeal abutments are comprised of specific abutment types (i.e., straight, angled, and base). Both the TiUltra implants and Xeal abutments are made of titanium and feature a surface treatment that preserves the hydrophilicity of the device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies performed for the Nobel Biocare AB TiUltra Implants and Xeal Abutments, as described in the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore section 2, 3, 4, 5, 6, 8, 9 are not applicable in this case.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for dental implants and abutments, the acceptance criteria are primarily focused on demonstrating substantial equivalence to predicate devices through various performance tests and material characterizations. Direct numerical "acceptance criteria" for specific clinical outcomes (like sensitivity/specificity for diagnostic AI) are not explicitly stated in this format. Instead, the "acceptance criteria" are implied to be meeting established performance specifications and not raising new questions of safety or effectiveness compared to the predicate devices. The reported performance is the result of demonstrating these equivalences through testing.

Implied Acceptance Criteria for Substantial Equivalence and Reported Device Performance:

Category	Acceptance Criteria (Implied)	Reported Device Performance (Summary from Studies)
Material Composition	Identical or substantially equivalent to predicate devices (Commercially pure titanium for implants, Titanium vanadium alloy for abutments).	TiUltra Implants: Commercially pure titanium. Xeal Abutments: Titanium vanadium alloy (ASTM F1472, ASTM F136). Demonstrated equivalence to predicate devices.
Indications for Use (IFU)	Same as predicate devices, supporting restorative dentistry and chewing function.	TiUltra Implants & Xeal Abutments: IFU are the same as their respective predicate devices.
Device Design & Dimensions	Dimensions (length, diameter, platform, angles) and macro-design features (e.g., thread design) are within ranges or equivalent to predicate devices.	TiUltra Implants: Same implant lengths, diameters, platform compatibility, and macro design as their respective primary predicate devices. Internal conical connection with hex interface. Xeal Abutments: Same compatible implant platforms, abutment height, width, and angulation as their respective predicate devices.
Surface Treatment & Topography (Implants)	Surface roughness (Sa) and oxide layer thickness are within the range of predicate devices, or differences are justified by testing. Hydrophilic properties are characterized.	TiUltra Implants: Three-level surface (collar, transition, body) with specified Sa and thickness values. Sa is within range of NobelActive and NobelReplace Hexagonal Implants. Multi-level anodization with similar roughness and oxide layer thickness range as NobelParallel Conical Connection (K173418). Hydrophilicity (contact angle) and conductivity (salt amount) characterized.
Surface Preservation (Implants & Abutments)	Functionally similar to predicate/reference devices, with differences justified by testing.	TiUltra Implants & Xeal Abutments: Soluble salt (protective) layer (sodium dihydrogen phosphate dihydrate and magnesium chloride hexahydrate). Similar in composition and function to the soluble calcium chloride salt on BTI Dental Implant System UnicCa® (K151391).
Implant/Abutment Connection	Interface characteristics are equivalent or differences are justified by testing.	TiUltra Implants: Anodic oxidation on collar and inside the connection. Demonstrated equivalence to wide platform NobelActive and NobelParallel Conical Connection. Differences from other predicates justified by bench testing.
Sterilization	Achieves a Sterility Assurance Level (SAL) of $10^{-6}$ using validated methods.	All Devices: Gamma Radiation (SAL $10^{-6}$).
Biocompatibility	Meets ISO 10993 standards for permanent implant devices with tissue/bone contact.	Expert toxicity assessment, dissolution kinetics, chemical characterization (ISO 10993-18), cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-10), material mediated pyrogenicity (ISO 10993-11), and acute systemic toxicity (ISO 10993-11), local effects after implantation (ISO 10993-6) all performed. Devices categorized as permanent, implant devices with tissue/bone contact.
Mechanical Performance	Withstands dynamic loading in accordance with ISO 14801 and FDA guidance. Implant-to-abutment connection shows acceptable wear.	Dynamic loading tests (ISO 14801 and FDA Guidance) completed. Assessment of implant-to-abutment connection platforms for wear of the anodized surface conducted.
Packaging Performance	Meets ISO 11607-1 requirements for terminally sterilized medical devices.	Testing conducted according to ISO 11607-1:2019.
Endotoxin Content	Meets endotoxin limits.	Endotoxin testing completed (USP 42-NF37 <151>, ANSI/AAMI ST72:2011/(R)2016).
Osseointegration & Tissue Attachment (Pre-clinical)	Demonstrates comparable early and late osseointegration and soft tissue attachment to predicate devices.	Animal Study: Exhibited the same early and late osseointegration and/or early and late soft tissue attachment behavior as predicates.
Clinical Outcomes (Real-World Evidence)	Demonstrates favorable clinical observations, implant survival, and lack of immediate adverse effects from technological differences.	Sponsor-Investigator Study: 61 patients. Successful soft tissue parameters (93%), 100% implant survival, only one adverse event (small dehiscence). Stable bone levels for four patients at 1-year follow-up.

Studies Proving Acceptance Criteria are Met:

The submission relies on a combination of non-clinical (bench, material characterization, animal) and real-world evidence (clinical) studies to demonstrate substantial equivalence.

Non-Clinical Testing:

Sterilization Validation: Conducted according to ISO 11137-1:2006 and ISO 11137-2:2013 to establish and validate a SAL of $10^{-6}$ for Gamma Radiation.
Endotoxin Testing: Performed per USP 42-NF37:2019 <151> and ANSI/AAMI ST72:2011/(R)2016.
Packaging Performance Testing: Conducted according to ISO 11607-1:2019.
Biocompatibility Testing: Comprehensive assessment following ISO 10993-1:2018 for permanent implant devices with tissue/bone contact. This included:
- Expert toxicity assessment.
- Dissolution kinetics of the soluble salt (protective) layer.
- Chemical characterization of leachables (ISO 10993-18:2009).
- Cytotoxicity assessment (ISO 10993-5:2009).
- Sensitization testing (ISO 10993-10:2010).
- Irritation testing (ISO 10993-10:2010).
- Material mediated pyrogenicity testing (ISO 10993-11:2017).
- Acute systemic toxicity testing (ISO 10993-11:2017).
- Local effects after implantation testing (ISO 10993-6:2016).
Mechanical Testing: Performed according to ISO 14801:2016 ("Dentistry - Implants — Dynamic loading test for endosseous dental implants") and the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004). An assessment of implant-to-abutment connection wear was also conducted.
Surface Treatment Characterization: Modified surface treatment was characterized per the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutment" (May 12, 2004). Additionally, specific tests for hydrophilic surface properties (contact angle measurements and conductivity/salt amount testing) were done.
Animal Study: A comparative study in a Yucatan mini-pig model, assessing clinical observations, clinical pathology, macroscopic observations, micro-CT for osseointegration, histomorphometry for osseointegration and soft tissue attachment, and histopathology for inflammatory response at 3, 6, and 13 weeks.

Clinical Testing (Real-World Evidence):

Sponsor-Investigator Study: A prospective, single-arm study.
Real World Evidence: Interim 18-month post-market surveillance data from CE mark recognizing countries and five case studies with 3-5 month follow-ups were also provided.

2. Sample Size for the Test Set and Data Provenance

Sponsor-Investigator Study (Clinical Test Set):
- Sample Size: 61 patients.
- Data Provenance: Prospective, single-arm, sponsor-investigator study conducted in Italy.
Animal Study (Pre-clinical Test Set):
- Sample Size: Not explicitly stated as a number of animals, but refers to a "Yucatan mini-pig model" and "its predicates," indicating multiple animals used for comparison.
- Data Provenance: Not specified, but likely a controlled laboratory setting.

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

Not Applicable (N/A): This is a 510(k) submission for a medical device (dental implants/abutments), not an AI/ML diagnostic tool. Therefore, "ground truth" as established by human experts for an AI test set is not relevant in this context. The "truth" for device performance is established through physical, chemical, and biological testing, and clinical observation against established medical criteria. For the animal study, veterinarians and pathologists would have established observations. For the human clinical study, dentists/oral surgeons and clinical researchers would have established the outcomes. The qualifications of these individuals are not specified in the 510(k) summary provided.

4. Adjudication Method for the Test Set

Not Applicable (N/A): This device is not an AI/ML diagnostic device requiring adjudication of expert readings. Clinical outcomes in the human study would be based on direct observation and measurement by investigators, and the animal study observations would be made by scientific personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No: An MRMC comparative effectiveness study, typically used for evaluating the impact of AI on human reader performance for diagnostic tasks, was not conducted. This is not applicable to a device like a dental implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable (N/A): This is a medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

For Non-Clinical Testing:
- Measurement Standards: Adherence to international standards (e.g., ISO, ASTM), physical and chemical characterization (e.g., surface roughness, material composition), and biological endpoints (e.g., cell viability, immune response).
- Pre-clinical (Animal Study): Histology/Histomorphometry, Micro-CT findings, clinical observations, and pathology assessments.
For Clinical Testing (Real-World Evidence):
- Clinical Outcomes: Implant survival, soft tissue parameters, occurrence of adverse events, and demonstration of stable bone levels via radiography. These are direct patient outcomes and clinical assessments made by medical professionals.

8. The Sample Size for the Training Set

Not Applicable (N/A): This device does not involve a "training set" in the context of AI/ML or statistical modeling. Its design and manufacturing are based on established engineering principles, material science, and prior predicate device designs for which extensive clinical experience exists.

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

Not Applicable (N/A): As there is no "training set" in the AI/ML sense, "ground truth establishment" for a training set is not applicable. The design and validation are based on scientific principles, regulatory standards, and comparative data to predicate devices.

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.

November 16, 2020

Nobel Biocare AB Bernice Jim Regulatory Affairs Manager Box 5190, SE-402 26 Vastra Hamngatan 1, Gotlands Län [SE-09] 411 17 SWEDEN

Re: K202344

Trade/Device Name: TiUltra Implants and Xeal Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE. NHA. PNP Dated: August 17, 2020 Received: August 18, 2020

Dear Bernice Jim:

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) K202344

Device Name

TiUltra Implants and Xeal Abutments

Indications for Use (Describe)

NobelActive TiUltra

Nobel Active TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing flunction.

Nobel Active TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible.

NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only.

NobelReplace CC TiUltra

NobelParallel CC TiUltra

Implants with < 7 mm length are for delayed loading only when appropriate stability has been achieved.

Remaining indications are continued on a separate page.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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INDICATIONS FOR USE FORM 3881 ATTACHMENT: INDICATIONS FOR USE (CONT.)

MUA Xeal

The MUA Xeal is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

On1 Base Xeal

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510(k) Notification K202344

Submitter

Nobel Biocare AB

Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Submitted by:

Nobel Biocare Services AG Balz Zimmermann-Strasse 7 8302 Kloten, Switzerland 92887

Contact Person:	Bernice Jim, Ph.D.,
E-Mail:	bernice.jim@nobelbiocare.com
Phone Number:	(+41) 79 855 00 73
Fax Number:	(+41) 43 211 42 42
Date Prepared:	16 November 2020
Device

Device

Trade Name:	TiUltra Implants and Xeal Abutments
Generic/Common Name:	Endosseous Dental Implants and Abutments
Regulation Name:	Endosseous Dental Implant
Regulation Number:	21 CFR 872.3640
Regulatory Class:	II
Product Code:	DZE
Secondary Product Code:	NHA, PNP

Predicate Devices

Table 1: Predicate Devices for the TiUltra implants and Xeal abutments

	Device	510(k)	Manufacturer
Primary Predicate	NobelActive	K142260	Nobel Biocare AB
Predicate #2	NobelReplace Hexagonal Implant	K073142	Nobel Biocare AB
Predicate #3 andReference #2	NobelParallel Conical Connection	K173418	Nobel Biocare AB
Predicate #4	Multi-unit Abutment Plus	K161416	Nobel Biocare AB
Predicate #5	On1 Universal Abutment	K181869	Nobel Biocare AB
Reference #1	BTI Dental Implant System UnicCa®	K151391	B.T.I. Biotechnology Institute
Reference #3	ST Internal Implant System	K192347	MegaGen Implant Co., Ltd.

Device Description

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510(k) SUMMARY

In compliance with the FDA Guidance Document entitled, "Bundling Multiple Devices or Multiple Indications in a Single Submission," issued June 22, 2007, Nobel Biocare is pursuing a single submission for both the TiUltra implants and Xeal abutments because this submission represents the enactment of a similar change across multiple device lines as listed in Table 2 below.

Subject Device	Device Lines	Description
TiUltra implants	NobelActive® TiUltra™	Endosseous dental implant
	NobelReplace® ConicalConnection (CC) TiUltra™	Endosseous dental implant
	NobelParallel™ConicalConnection (CC) TiUltra™	Endosseous dental implant
Xeal abutments	Multi-unit Abutment Xeal™	Endosseous dental abutment
	On 1 Base Xeal™	Endosseous dental abutment

Table 2: Devices Included in this 510(k) Submission
-----------------------------------------------------	--	--

An overview of TiUltra implants and Xeal abutments: platforms, diameters, lengths, collar heights, and abutment angles are provided below in Table 3 and Table 4, respectively.

Table 3: TiUltra implant Product Range

SubjectDevice	ImplantLines	Platform	Diameter (mm)	Length (mm)
TiUltraimplants	NobelActiveTiUltra	3.0	3.0	10.0, 11.5, 13.0, 15.0
		NP	3.5	8.5, 10.0, 11.5, 13.0, 15.0, 18.0
		RP	4.3	8.5, 10.0, 11.5, 13.0, 15.0, 18.0
			5.0	8.5, 10.0, 11.5, 13.0, 15.0, 18.0
		WP	5.5	7.0, 8.5, 10.0, 11.5, 13.0, 15.0
	NobelReplaceCC TiUltra	NP	3.5	8.0, 10.0, 11.5, 13.0, 16.0
		RP	4.3	8.0, 10.0, 11.5, 13.0, 16.0
			5.0	8.0, 10.0, 11.5, 13.0, 16.0
	NobelParallelCC TiUltra	NP	3.75	6.5, 8.0, 9.5, 11.0, 12.5, 14.5, 17.5
		RP	4.3	6.5, 8.0, 9.5, 11.0, 12.5, 14.5, 17.5
			5.0	6.5, 8.0, 9.5, 11.0, 12.5, 14.5, 17.5
		WP	5.5	6.5, 8.0, 9.5, 11.0, 12.5, 14.5

Table 4: Xeal abutment Platform Variations

SubjectDevice	Abutment Line	Abutment Angle	Platform	Collar Height (mm)
Xealabutments	Multi-unitAbutment Xeal(MUA)	0° (straight)	NP	1.5, 2.5, 3.5
			RP	1.5, 2.5, 3.5, 4.5
			WP	1.5, 2.5, 3.5
		17°	NP	2.5, 3.5
			RP	2.5, 3.5
			WP	2.5, 3.5
		30°	NP	3.5, 4.5
			RP	3.5, 4.5
Xealabutments	On1 Base Xeal	Base	NP	1.75, 2.5
		Base	RP	1.75, 2.5
		Base	WP	1.75, 2.5

The proposed On1 Base Xeal abutments is utilized with the On1 Universal Abutments. The On1 Universal Abutments are always to be used as multi-piece abutments, incorporating use of a

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510(k) SUMMARY

coronal ceramic mesostructure or hybrid abutment/crown and dental cement for bonding the components.

The Onl Universal Abutment is a dental implant abutment which attaches to the On1 Base of the Onl Concept (K161655) and is intended to be used with the current Nobel Biocare dental implants that have the existing internal conical connection.

The On1 Universal Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for either an in-laboratory CAD/CAM system made mesostructure or abutment crown. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process.

The digital workflow requires the use of the following equipment:

Scanner: 3Shape intra oral scanner Trios (3Shape A/S) -
Design Software: 3Shape Abutment Designer Software (3Shape A/S) --K151455 where the Implant Libraries are obtained via the 3Shape server in the software
Restorative Material: Enamic (Vita Zahnfabrik H. Rauter GmbH Co) --K153645
Milling Unit: CORiTEC, imes-icore milling unit -

The following restorative design specifications is required:

Restorative design specifications for Universal Base
Parameter	Specification
Angle from axis of theimplant	20° Max
Wall Thickness Circular	0.8mm min.
Wall Thickness Margin	0.275mm min.
Post Height	5.2mm min.
Maximum Length, width andHeight	EM-14 blank 12x14x18mmEM-10 blank 8x10x15mm

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Indications for Use

NobelActive TiUltra

NobelActive TiUltra implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.

NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only.

NobelReplace CC TiUltra

NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function.

The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC TiUltra implants can be used in splinted or non-splinted applications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelParallel CC TiUltra

NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with <7mm length are for delayed loading only when appropriate stability has been achieved.

MUA Xeal

The MUA Xeal is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

On1 Base Xeal

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Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

Comparison of Technological Characteristics

TiUltra Implants

The intended use and Indications for Use for each TiUltra implant subject device is the same as each respective predicate. The subject and respective predicate devices are endosseous dental implants to support prosthetic devices in order to restore patient esthetics and chewing function. Therefore, the devices are substantially equivalent in consideration of the intended use and Indications for Use.

Further, the devices are highly consistent with respect to technological characteristics. The sets of devices have the same material, device implant length and width, platforms, connection shape and macro design. There are a few technological differences between the subject devices and their respective predicate devices, which do not raise different questions of substantial equivalence, summarized as follows: surface topography (roughness and thickness), surface preservation, implant/abutment connection, and packaging. The TiUltra implants' surface roughness and corresponding oxide layer thicknesses are within the range of the TiUnite - Gradient surface featured on NobelParallel Conical Connection (K173418 - Predicate #3 and Reference #2). The surface roughness, oxide layer thicknesses of the multi-level anodization and salt surface preservation differences did not raise different questions of safety and effectiveness as demonstrated by fatigue testing, surface characterization, and performance testing via an animal study. Therefore, the summarized differences between the TiUltra implant subject device and predicate devices do not raise different questions of substantial equivalence as confirmed by respective verification and validation testing. Therefore, the subject and predicate devices are substantially equivalent.

Xeal Abutments

The intended use and Indications for Use for each Xeal abutment subject device is the same as each respective predicate. The subject and respective predicate devices are intended to be used with endosseous dental implants and be used as an aid in prosthetic rehabilitation. Therefore, the devices are substantially equivalent in consideration of the intended use and Indications for Use.

Further, the subject and predicate devices are highly consistent with respect to technological characteristics. The sets of devices have the same compatible implant platforms, material, abutment height and width, abutment angulation, surface topography, and packaging. There are two technological differences between the subject devices and their respective predicate devices, which do not raise different questions of substantial equivalence, summarized as follows: surface treatment and surface preservation. The summarized differences between the Xeal abutment subject device and predicate devices do not raise different questions of substantial equivalence as confirmed by respective verification and validation testing. Therefore, the subject and predicate devices are substantially equivalent.

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510(k) SUMMARY

	Subject DeviceTiUltra Implants	Predicate DeviceNobelActive(K142260 – PrimaryPredicate)	Predicate DeviceNobelReplace HexagonalImplant(K073142 – Predicate #2)	Predicate DeviceNobelParallel ConicalConnection(K173418 – Predicate #3and Reference #2)1	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 – Reference#1)	Comparison
TechnologicalCharacteristics
PictorialRepresentation	Image: NobelActive TiUltra	Image: NobelActive	Image: NobelReplace Hexagonal Implant	Image: NobelParallel Conical Connection	N/A	--
	Image: NobelReplace CC TiUltra
	Image: NobelParallel CC TiUltra
RegulatoryClassification	21 CFR 872.3640Endosseous dental implant	21 CFR 872.3640Endosseous dental implant	21 CFR 872.3640Endosseous dental implant	21 CFR 872.3640Endosseous dental implant	21 CFR 872.3640Endosseous dental implant	All devices have theregulatory classification, 21
TechnologicalCharacteristics	Subject DeviceTiUltra Implants	Predicate DeviceNobelActive(K142260 - PrimaryPredicate)	Predicate DeviceNobelReplace HexagonalImplant(K073142 - Predicate #2)	Predicate DeviceNobelParallel ConicalConnection(K173418 - Predicate #3and Reference #2)1	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 - Reference#1)	Comparison
						CFR 872.3640, Endosseousdental implant.
Product Code	DZE	DZE, NHA	DZE	DZE	DZE	All devices have the productcode, DZE.
Indications for Use	NobelActive TiUltraNobelActive TiUltraimplants are endosseousimplants intended to besurgically placed in theupper or lower jaw bonefor anchoring orsupporting toothreplacements to restorepatient esthetics andchewing function.NobelActive TiUltraimplants are indicated forsingle or multiple unitrestorations in splinted ornon-splinted applications.This can be achieved by a2-stage or 1-stage surgicaltechnique in combinationwith immediate, early ordelayed loading protocols,recognizing sufficientprimary stability andappropriate occlusalloading for the selectedtechnique.NobelActive TiUltra 3.0implants are intended toreplace a lateral incisor inthe maxilla and/or acentral or lateral incisor inthe mandible.NobelActive TiUltra 3.0implants are indicated forsingle-unit restorationsonly.NobelReplace CCTiUltraNobelReplace CC TiUltraimplants are endosseous	NobelActive implants areendosseous implantsintended to be surgicallyplaced in the upper or lowerjaw bone for anchoring orsupporting toothreplacements to restorepatient esthetics andchewing function.NobelActive implants areindicated for single ormultiple unit restorations insplinted or non-splintedapplications. This can beachieved by a 2-stage or 1-stage surgical technique incombination withimmediate, early or delayedloading protocols,recognizing sufficientprimary stability andappropriate occlusalloading for the selectedtechnique.NobelActive 3.0 implantsare intended to replace alateral incisor in the maxillaand/or a central or lateralincisor in the mandible.NobelActive 3.0 implantsare indicated for single-unitrestorations only.	Nobel Biocare'sNobelReplace HexagonalImplants are endosseousimplants intended to besurgically placed in thebone of the upper or lowerjaw arches to providesupport for prostheticdevices, such as an artificialtooth, in order to restorepatient esthetics andchewing function.The NobelReplaceHexagonal Implants areindicated for single ormultiple unit restorations.The NobelReplaceHexagonal Implants can beused in splinted or non-splinted applications.The NobelReplaceHexagonal Implants may beplaced immediately and putinto immediate functionprovided that initialstability requirementsdetailed in the manual aresatisfied.	NobelParallel ConicalConnection implants areendosseous implantsintended to be surgicallyplaced in the upper orlower jaw bone foranchoring or supportingreplacements to restorepatient esthetics andchewing function.NobelParallel ConicalConnection implants areindicated for single ormultiple restorations insplinted or non-splintedapplications. This can beachieved by a 2-stage or 1-stage surgical techniques incombination withimmediate, early or delayedloading protocols,recognizing sufficientprimary stability andappropriate occlusalloading for the selectedtechnique.Implants with <7mm lengthare for delayed loadingonly when appropriatestability has been achieved.	The BTI Dental ImplantSystem UnicCa® for oralimplant surgery is to beused for the partial or totalreplacement of teeth inedentulate patients. Onceattached to the bone, theimplants act as an anchorfor various fixed orremovable prostheticsolutions that can be usedto improve or restore apatient's masticationfunction.In the case of 5.5 - 6.5mmlong UnicCa® implantsshould be used in a two-stage surgical procedure.These implants areindicated for delayedloading. These implantsare indicated only forstraight abutments and tosupport permanently fixedrestorations.In the case of Tiny® 3.0UnicCa® implants: Theseimplants shall be usedonly to replace maxillarylateral incisors andmandibular lateral andcentral incisors.Immediate loading isrecommended when thereis good primary stabilityand an appropriateocclusal load.	NobelActive TiUltra has thesame Indications for Use asNobelActive (K142260 –Primary Predicate).NobelReplace CC TiUltra hasthe same Indications for Useas NobelReplace HexagonalImplant (K073142 -Predicate #2).NobelParallel CC TiUltra hasthe same Indications for Useas NobelParallel ConicalConnection (K173418 -Predicate #3).
TechnologicalCharacteristics	Subject DeviceTiUltra Implants	Predicate DeviceNobelActive(K142260 – PrimaryPredicate)	Predicate DeviceNobelReplace HexagonalImplant(K073142 – Predicate #2)	Predicate DeviceNobelParallel ConicalConnection(K173418 – Predicate #3and Reference #2)1	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 – Reference#1)	Comparison
	dental implants intended tobe surgically placed in thebone of the upper or lowerjaw arches to providesupport for prostheticdevices, such as anartificial tooth, in order torestore patient estheticsand chewing function.The NobelReplace CCTiUltra implants areindicated for single ormultiple unit restorations.The NobelReplace CC
	TiUltra implants can beused in splinted or non-splinted applications.The NobelReplace CCTiUltra implant may beplaced immediately andput into immediatefunction provided thatinitial stabilityrequirements detailed inthe manual are satisfied.
	NobelParallel CCTiUltraNobelParallel CC TiUltraimplants are endosseousimplants intended to besurgically placed in theupper or lower jaw bonefor anchoring orsupporting replacementsto restore patient estheticsand chewing function.NobelParallel CC TiUltraimplants are indicated forsingle or multiplerestorations in splinted ornon-splinted applications.This can be achieved by a2-stage or 1-stage surgicaltechniques in combination
		Subject Device	Predicate Device	Predicate Device	Predicate Device	Reference Device	Comparison
	TechnologicalCharacteristics	TiUltra Implants	NobelActive(K142260 - PrimaryPredicate)	NobelReplace HexagonalImplant(K073142 - Predicate #2)	NobelParallel ConicalConnection(K173418 - Predicate #3and Reference #2)1	BTI Dental ImplantSystem UnicCa®(K151391 - Reference#1)
		delayed loading protocols,recognizing sufficientprimary stability andappropriate occlusalloading for the selectedtechnique.Implants with <7mmlength are for delayedloading only whenappropriate stability hasbeen achieved.
DesignFeatures	ImplantLength	NobelActive TiUltra7.0, 8.5, 10.0, 11.5, 13.0,15.0, 18.0mmNobelReplace CCTiUltra8.0, 10.0, 11.5, 13.0,16.0mmNobelParallel CCTiUltra6.5, 8.0, 9.5, 11.0, 12.5,14.5, 17.5mm	7.0, 8.5, 10.0, 11.5, 13.0,15.0, 18.0mm	8.0, 10.0, 13.0, 16.0mm	6.5, 8.0, 9.5, 11.0, 12.5,14.5, 17.5mm	Interna : 5.5, 6.5, 7.5, 8.5,10.0, 11.5, 13.0, 15.0,18.0mmExterna : 7.5, 8.5, 10.0,11.5, 13.0, 15.0, 18.0mm	NobelActive TiUltra has thesame implant lengths asNobelActive (K142260 -Primary Predicate).NobelReplace CC TiUltra hasthe same implant lengths asNobelReplace HexagonalImplant (K073142 -Predicate #2).NobelParallel CC TiUltra hasthe same implant lengths asNobelParallel ConicalConnection (K173418 -Predicate #3).
	ImplantDiameter	NobelActive TiUltra3.0, 3.5, 4.3, 5.0, 5.5mmNobelReplace CCTiUltra3.5, 4.3, 5.0mmNobelParallel CCTiUltra3.75, 4.3, 5.0, 5.5mm	3.0, 3.5, 4.3, 5.0, 5.5mm	3.5, 4.3, 5.0mm	3.75, 4.3, 5.0, 5.5mm	Interna : 3.3, 3.5, 3.75,4.0, 4.25, 4.5, 5.0, 5.5,6.0mmExterna :3.0, 3.3, 3.5,3.75, 4.0, 4.5, 5.0, 5.5mm	NobelActive TiUltra has thesame implant diameter asNobelActive (K142260 -Primary Predicate).NobelReplace CC TiUltra hasthe same implant diameter asNobelReplace HexagonalImplant (K073142 -Predicate #2).NobelParallel CC TiUltra hasthe same implant diameter asNobelParallel ConicalConnection (K173418 -Predicate #3).
TechnologicalCharacteristics	Subject DeviceTiUltra Implants	Predicate DeviceNobelActive(K142260 - PrimaryPredicate)	Predicate DeviceNobelReplace HexagonalImplant(K073142 - Predicate #2)	Predicate DeviceNobelParallel ConicalConnection(K173418 - Predicate #3and Reference #2)¹	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 - Reference#1)	Comparison
PlatformCompatibility	NobelActive TiUltra• 3.0 Platform• Narrow Platform(NP)• Regular Platform(RP)• Wide Platform(WP)NobelReplace CCTiUltra• Narrow Platform(NP)• Regular Platform(RP)NobelParallel CCTiUltra• Narrow Platform(NP)• Regular Platform(RP)• Wide Platform(WP)	• 3.0 Platform• Narrow Platform(NP)• Regular Platform(RP)• Wide Platform(WP)	• Narrow Platform(NP)• Regular Platform(RP)	• Narrow Platform(NP)• Regular Platform(RP)• Wide Platform (WP)	N/A	NobelActive TiUltra has thesame platform compatibilityas NobelActive (K142260 –Primary Predicate).NobelReplace CC TiUltra hasthe same platformcompatibility asNobelReplace HexagonalImplant (K073142 –Predicate #2).NobelParallel CC TiUltra hasthe same platformcompatibility asNobelParallel ConicalConnection (K173418 –Predicate #3).
ConnectionType	Internal conicalconnectionwith hex interface	Internal conical connectionwith hex interface	Internal conical connectionwith hex interface	Internal conical connectionwith hex interface	Internal (Interna) andExternal (Externa)	The subject and predicatedevices have the connectiontype, Internal conicalconnection with hexinterface.
MacroDesign	NobelActive TiUltraTapered implant withback-tapered coronaldesign, reverse-cuttingflutes and double leadthreadsNobelReplace CCTiUltraTapered implant withsingle lead threadsNobelParallel CCTiUltraDouble lead thread with	Tapered implant with back-tapered coronal design,reverse-cutting flutes anddouble lead threads	Tapered implant with singlelead threads	Double lead thread withgroove; Tapered apex withbone cutting flutes, slightlytapered body	Threaded, root form	NobelActive TiUltra has thesame macro design asNobelActive (K142260 –Primary Predicate).NobelReplace CC TiUltra hasthe same macro design asNobelReplace HexagonalImplant (K073142 –Predicate #2).NobelParallel CC TiUltra hasthe same macro design asNobelParallel Conical
	Subject DeviceTiUltra Implants	Predicate DeviceNobelActive(K142260 - PrimaryPredicate)	Predicate DeviceNobelReplace HexagonalImplant(K073142 - Predicate #2)	Predicate DeviceNobelParallel ConicalConnection(K173418 - Predicate #3and Reference #2)1	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 - Reference#1)	Comparison
TechnologicalCharacteristics
	with bone cutting flutes,slightly tapered body					Connection (K173418 –Predicate #3).
Material	Commercially puretitanium	Commercially puretitanium	Commercially puretitanium	Commercially puretitanium	Commercially puretitanium	The material used for alldevices is commercially puretitanium.
SurfaceTreatment	Anodic oxidation	Anodic oxidation	Anodic oxidation	Anodic oxidation	Grit blasted and acidetched, machined	The subject and predicatedevices have the surfacetreatment, anodic oxidation.
Implant/Abutmentconnection	Anodic oxidation oncollar and inside theconnection	Machined on collar andinside the connection (NPand RP platforms)Anodic oxidation on collarand inside the connection(WP platform)	Anodic oxidation on collarand machined inside theconnection	Anodic oxidation on collarand inside the connection	N/A	NobelActive TiUltra has thesame implant/abutmentconnection as the wideplatform NobelActive(K142260 - PrimaryPredicate) and NobelParallelConical Connection(K173418 - Reference #2).The differences do not raisedifferent questions ofsubstantial equivalence asdemonstrated by benchtesting.NobelReplace CC TiUltra hasa similar implant/abutmentconnection as NobelReplaceHexagonal Implant (K073142– Predicate #2) and the sameimplant/abutment connectionas NobelParallel ConicalConnection (K173418 –Reference #2). Thedifferences do not raisedifferent questions ofsubstantial equivalence asdemonstrated by benchtesting.NobelParallel CC TiUltra hasthe same implant/abutmentconnection as NobelParallelConical Connection(K173418 - Predicate #3)
TechnologicalCharacteristics	Subject DeviceTiUltra Implants	Predicate DeviceNobelActive(K142260 – PrimaryPredicate)	Predicate DeviceNobelReplace HexagonalImplant(K073142 – Predicate #2)	Predicate DeviceNobelParallel ConicalConnection(K173418 – Predicate #3and Reference #2)¹	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 – Reference#1)	Comparison
SurfaceTopography	TiUltra –Three level surface:• Level 0 (collar):o Sa (arearoughness) = $0.5 ± 0.3µm$o Thickness (Thk)= $0.166±0.008μm$• Level 1 (transition):o Sa = $0.8 ±0.3µm$o Thk = $7.5±0.3µm$• Level 2 (body):o Sa = $1.5 ±0.4µm$o Thk =$12.0±1.2µm$	TiUnite – Single levelsurface:• Sa = $1.2 ±0.5µm$• Thk = $12.5±2.5µm$	TiUnite – Single levelsurface:• Sa = $1.2 ±0.5µm$• Thk = $12.5±2.5µm$	TiUnite – Gradientsurface:• Level 0 (collar):machined,o Sa $<1.6 µm$o Thk = $< 0.02µm$• Level 1 (transition):o Sa = $0.8 ±0.5µm$o Thk ~ $10 ±2.5µm$• Level 2 (body):o Sa = $1.2 ±0.5µm$o Thk ~ $12.5±2.5µm$	Neck: Sq2 $0.7 ± 0.1µm$ ;Sdr3 $50± 10%$Thread: Sq $≥1.2 µm$ ; Sdr $≥$200%Valleys: Sq= $1.0±0.2µm$ ;Sdr= $85± 15%$	The TiUltra implants' surfaceroughness, is within the rangeof NobelActive (K142260 –Primary Predicate) andNobelReplace HexagonalImplant (K073142 –Predicate #2). The Devicefeatures multi-levels ofanodization with a similarroughness and oxide layerthickness range asNobelParallel ConicalConnection (K173418 –Predicate #3 and Reference#2).The differences do not raisedifferent questions ofsubstantial equivalence asdemonstrated by bench andanimal testing.
Surfacepreservation	Hydrophilic surfaceSodium dihydrogenphosphate dihydrate andmagnesium chloridehexahydrate salt	N/A	N/A	N/A	UnicCa hydrophilicsurfaceSoluble calcium chloridesalt	The surface preservation issimilar in composition andfunction as the solublecalcium chloride salt appliedto BTI Dental ImplantSystem UnicCa® (K151391– Reference #1). Thedifferences do not raisedifferent questions ofsubstantial equivalence asdemonstrated by bench andanimal testing.
Packaging	Polyethylene terephthalate(PET) vial with highdensity poly ethylene(HDPE) cap (1st sterilebarrier) placed in apolyethylene terephthalateglycol (PETG) blister(2nd sterile barrier) inside	Polystyrene (PS) vial withprotection elements. Thevial is securely closed withHDPE cap forming asterile barrier.	Polystyrene (PS) vial withprotection elements. Thevial is securely closed withHDPE cap forming asterile barrier.	Polystyrene (PS) vial withprotection elements. Thevial is securely closed withHDPE cap forming asterile barrier.	Unique container(vial with clamp)	Packaging differences do notraise different questions ofsubstantial equivalence asdemonstrated by benchtesting.

' NobelParallel Concal Connection K173418 is Pedical CC Tilltra(subject device) and Reference #2 br NobelAcive and NobelReplace CC TiUlta(subject devices)

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Table 5: Comparison of the TiUltra implants with Predicate Implants (Cont.)

2 Sq: Root Square Mean Roughness.

3 Sdr= Developed surface.

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TechnologicalCharacteristics	Subject DeviceTiUltra Implants	Predicate DeviceNobelActive(K142260 – PrimaryPredicate)	Predicate DeviceNobelReplace HexagonalImplant(K073142 – Predicate #2)	Predicate DeviceNobelParallel ConicalConnection(K173418 – Predicate #3and Reference #2)¹	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 – Reference#1)	Comparison
	a cardboard box(protective packaging).
Sterilization (SAL)	Gamma Radiation (SAL$10^{-6}$ )	Gamma Radiation (SAL$10^{-6}$ )	Gamma Radiation (SAL$10^{-6}$ )	Gamma Radiation (SAL$10^{-6}$ )	Gamma Radiation (SAL$1x10^{-6}$ )	All devices are sterilizedwith Gamma Radiation (SAL$1x10^{-6}$ ).

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510(k) SUMMARY

TechnologicalCharacteristics	Subject DeviceXeal abutments	Predicate DeviceMulti-unit AbutmentPlus (K161416 –Predicate #4)	Predicate DeviceOn1 Universal Abutment(Base)(K181869 – Predicate #5)	Reference DeviceEZ Post Abutment forST Internal ImplantSystem (K192347 –Reference #3)	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 – Reference#1)	Comparison
Pictorial Representation	Multi-unit AbutmentXealImage: Multi-unit Abutment Xeal	Image: Multi-unit Abutment Plus	Image: On1 Universal Abutment and On1 Base	Image: EZ Post Abutment	N/A
RegulatoryClassification	21 CFR 872.3630Endosseous dentalimplant abutment	21 CFR 872.3630Endosseous dentalimplant abutment	21 CFR 872.3630Endosseous dentalimplant abutment	21 CFR 872.3640Endosseous dentalimplant	21 CFR 872.3640Endosseous dentalimplant	The subject and predicate deviceshave the regulatory classification,21 CFR 872.3630, Endosseousdental implant abutment.
Product Code	NHA	NHA	NHA, PNP	DZE, NHA	DZE	The subject and predicate deviceshave the product code, NHA.

Table 6: Comparison of the Xeal abutments with Predicate Devices

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TechnologicalCharacteristics	Subject DeviceXeal abutments	Predicate DeviceMulti-unit AbutmentPlus (K161416 –Predicate #4)	Predicate DeviceOn1 Universal Abutment(Base)(K181869 – Predicate #5)	Reference DeviceEZ Post Abutment forST Internal ImplantSystem (K192347 –Reference #3)	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 – Reference #1)	Comparison
Indications for Use	MUA XealThe MUA Xeal is apremanufacturedprosthetic componentdirectly connected to theendosseous dental implantand is intended for use asan aid in prostheticrehabilitation.On1 Base XealThe On1 Base Xealdevice is apremanufacturedprosthetic componentdirectly connected to anendosseous implant and itis intended for use inprosthetic rehabilitation.The On1 UniversalAbutments consist ofthree major parts.Specifically, the On1Base Xeal, the On1Universal Abutment, andthe mesostructurecomponents make up amulti-piece abutment.The system integratesmultiple components ofthe digital dentistryworkflow: scan files fromIntra-Oral Scanners, CADsoftware, CAM software,ceramic material, millingmachine and associatedtooling and accessories.	The Multi-unit AbutmentPlus is a pre-manufactured prostheticcomponent directlyconnected to theendosseous dental implantand is intended for use asan aid in prostheticrehabilitation.	The On1™ device is apremanufacturedprosthetic componentdirectly connected to anendosseous implant and itis intended for use inprosthetic rehabilitation.The On1 UniversalAbutments consist ofthree major parts.Specifically, the On1Base, the On1 UniversalAbutment, and themesostructurecomponents make up amulti-piece abutment. Thesystem integrates multiplecomponents of the digitaldentistry workflow: scanfiles from Intra-OralScanners, CAD software,CAM software, ceramicmaterial, milling machineand associated tooling andaccessories.	The ST Internal ImplantSystem is intended to besurgically placed in themaxillary or mandibulararches for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore a patient'schewing function.Smaller implants (lessthan 6.0mm) arededicated for immediateloading when goodprimary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region and areindicated for delayedloading.	The BTI Dental ImplantSystem UnicCa® fororal implant surgery is tobe used for the partial ortotal replacement of teethin edentulate patients.Once attached to thebone, the implants act asan anchor for variousfixed or removableprosthetic solutions thatcan be used to improveor restore a patient'smastication function.In the case of 5.5 –6.5mm long UnicCa®implants should be usedin a two-stage surgicalprocedure. Theseimplants are indicatedfor delayed loading.These implants areindicated only forstraight abutments and tosupport permanentlyfixed restorations.In the case of Tiny® 3.0UnicCa® implants:These implants shall beused only to replacemaxillary lateral incisorsand mandibular lateraland central incisors.Immediate loading isrecommended whenthere is good primarystability and anappropriate occlusalload	MUA Xeal has the sameIndications for Use as Multi-unitAbutment Plus (K161416 –Predicate #4).On1 Base Xeal has the sameIndications for Use as On1Universal Abutment (Base)(K181869 – Predicate #5).
		Subject DeviceXeal abutments	Predicate DeviceMulti-unit AbutmentPlus (K161416 –Predicate #4)	Predicate DeviceOn1 Universal Abutment(Base)(K181869 – Predicate #5)	Reference DeviceEZ Post Abutment forST Internal ImplantSystem (K192347 –Reference #3)	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 – Reference#1)	Comparison
	TechnologicalCharacteristics
DesignFeatures	CompatibleImplantsPlatforms	Nobel Biocare InternalConical Connection• Narrow Platform (NP)• Regular Platform (RP)• Wide Platform (WP)	Nobel Biocare InternalConical Connection• Narrow Platform (NP)• Regular Platform (RP)• Wide Platform (WP)	Nobel Biocare InternalConical Connection• Narrow Platform (NP)• Regular Platform (RP)• Wide Platform (WP)	Hex, Non-Hex	N/A	The subject and predicate devicesare compatible with the NP, RP,and WP implant platforms.
	AbutmentHeight	MUA Xeal1.5, 2.5, 3.5, 4.5mmOn1 Base XealCombined base and postheight• Temporary Abut –8.3, 9.0mm• Esthetic Abut Ti – 8.2,9.0mm• Esthetic Abut Zi – 8.2,9.0mm	1.5, 2.5, 3.5, 4.5mm	Combined base and postheight• Temporary Abut – 8.3,9.0mm• Esthetic Abut Ti – 8.2,9.0mm• Esthetic Abut Zi – 8.2,9.0mm	Post Height:4.0, 5.5, 7.0mmGingival Height:1.0, 2.0, 3.0, 4.0, 5.0mm	N/A	MUA Xeal has the same abutmentheight as Multi-unit AbutmentPlus (K161416 – Predicate #4).On1 Base Xeal has the sameabutment height as On1 UniversalAbutment (Base) (K181869 –Predicate #5).
	AbutmentWidth	MUA Xeal4.8mmOn1 Base XealAt base 4.8, 5.3, 6.5mm	4.8mm	At base 4.8, 5.3, 6.5mm	4.6, 5.0, 6.0, 7.0mm	N/A	MUA Xeal has the same abutmentwidth as Multi-unit AbutmentPlus (K161416 – Predicate #4).On1 Base Xeal has the sameabutment width as On1 UniversalAbutment (Base) (K181869 –Predicate #5).
	AbutmentAngulation	MUA Xeal0°, 17°, 30°On1 Base Xeal0° angulation of the Base -0-20° angulation of theceramic mesostructure	0°, 17°, 30°	No abutment angulation	0°	N/A	MUA Xeal has the same abutmentangulation as Multi-unit AbutmentPlus (K161416 – Predicate #4).On1 Base Xeal has the sameabutment angulation as On1Universal Abutment (Base)(K181869 – Predicate #5).
	Material	Titanium vanadium alloy(ASTM F1472, ASTMF136)	Titanium vanadium alloy(ASTM F1472, ASTMF136)	Titanium vanadium alloy(ASTM F1472, ASTMF136)	Ti-6A1-4V ELI	Commercially PureTitanium	The material used for the subjectand predicate devices is Titaniumvanadium alloy (ASTM F1472,ASTM F136).
TechnologicalCharacteristics	Subject DeviceXeal abutments	Predicate DeviceMulti-unit AbutmentPlus (K161416 –Predicate #4)	Predicate DeviceOn1 Universal Abutment(Base)(K181869 – Predicate #5)	Reference DeviceEZ Post Abutment forST Internal ImplantSystem (K192347 –Reference #3)	Reference DeviceBTI Dental ImplantSystem UnicCa®(K151391 – Reference#1)	Comparison
AbutmentSurfaceTreatment	Anodization	No surface treatment	No surface treatment	Anodization	N/A	The subject devices and EZ PostAbutment for ST Internal ImplantSystem (K192347 – Reference #3)have an anodization surfacetreatment. The differences do notraise different questions ofsubstantial equivalence asdemonstrated by bench testing.
AbutmentSurfaceTopography	Xeal – Single levelsurface• Sa<0.8µm	Machined – Single levelsurface• Sa<0.8µm	Machined – Single levelsurface• Sa<0.8µm	N/A	N/A	The subject and predicate deviceshave a surface roughness of Sa<0.8µm.
SurfacePreservation	Soluble salt (protective)layer: Sodium dihydrogenphosphate dihydrate(NaH2PO4·2H2O) andmagnesium chloridehexahydrate(MgCl2·6H2O)	N/A	N/A	N/A	UnicCa hydrophilicsurface Soluble calciumchloride salt	The surface preservation is similarin composition and function as thesoluble calcium chloride saltapplied to BTI Dental ImplantSystem UnicCa® (K151391 –Reference #1). The differences donot raise different questions ofsubstantial equivalence asdemonstrated by bench andanimal testing.
Abutment Packaging	Thermoformedpolyethylene terephthalateglycol (PETG) tray withmedical paper lid forminga sterile barrier.	Thermoformed PETG traywith medical paper lidforming a sterile barrier.	Thermoformed PETG traywith medical paper lidforming a sterile barrier.	N/A	N/A	The subject and predicate devicesthe packaging, thermoformedPETG tray with medical paper lidforming a sterile barrier.
Sterilization (SAL)	Gamma Radiation (SAL10-6)	Gamma Radiation (SAL10-6)	Gamma Radiation (SAL10-6)	Non-sterile; intended forterminal sterilization viamoist heat(autoclave)	Gamma Radiation (SAL1x10-6)	The subject and predicate devicesare sterilized with GammaRadiation (SAL 10-6).

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Table 6: Comparison of the Xeal abutments with Predicate Devices (Cont.)

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Table 6: Comparison of the Xeal abutments with Predicate Devices (Cont.)

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Summary of Non-Clinical Testing

The following performance testing was submitted in this 510(k) to support substantial equivalence:

. Sterilization Validation in accordance with:
- ISO 11137-1:2006、Sterilization of health care products Radiation Part 1 : O Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2: 2013, Sterilization of health care products Radiation Part 2: о Establishing the sterilization dose
Endotoxin testing was completed in accordance with: ●
- USP 42-NF37:2019 <151>, Medical Devices-Bacterial Endotoxinand Pyrogen O Tests
- 0 ANSI/AAMI ST72:2011/ (R)2016, Bacterial endotoxins Test methods, routine monitoring, and alternatives to batch testing
Packaging performance testing was conducted according to ISO 11607-1:2019, Packaging for terminally sterilized medical devices - Part 1 : Requirements for materials, sterile barrier systems and packaging systems
Biocompatibility was conducted according to ISO 10993-1:2018, Biological evaluation ● of medical devices - Part 1: Evaluation and testing within a risk management process and includes:
- Expert toxicity assessment; O
- Dissolution kinetics of the soluble salt (protective) layer; O
- Chemical characterization according to ISO 10993-18:2009, for the chemical O characterization of leachables;
- Cytotoxicity assessment according to ISO 10993-5:2009; O
- Sensitization testing according to ISO 10993-10:2010; O
- O Irritation testing according to ISO 10993-10:2010;
- Material mediated pyrogenicity testing according to ISO 10993-11:2017; and O
- Acute systemic toxicity testing according to ISO 10993-11:2017. O
- Local effects after implantation testing according to ISO 10993-6:2016 o

The TiUltra implants and Xeal abutments are categorized as permanent, implant devices with tissue / bone contact according to ISO 10993-1. The TiUltra implants are made of commercial pure titanium and the Xeal abutments are made of titanium vanadium alloy (ASTM F1472, ASTM 136). For surface preservation, the finished product contains a soluble salt (protective) layer composed of sodium dihydrogen phosphate dihydrate (NaH2PO4-2H2O) and magnesium chloride hexahydrate (MgCl2-6H2O).

. Mechanical Testing was conducted according to ISO 14801:2016 Dentistry - Implants — Dynamic loading test for endosseous dental implants and the FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004). Following dynamic loading, an assessment of the implant-to-abutment connection platforms was conducted for wear of the anodized surface.

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Modified surface treatment was characterized according to the FDA Guidance ● Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutment" (May 12, 2004). Additionally, testing specific to the hydrophilic surface was conducted including hydrophilicity (contact angle) measurements and conductivity (salt amount) testing.
An Animal Study was conducted on the TiUltra implants and Xeal abutments and its ● predicates in a Yucatan mini-pig model. The comparative study conducted: clinical observations including clinical pathology, macroscopic observations, micro-CT to assess osseointegration. histomorphometry to assess osseointegration and soft tissue attachment. as well as histopathology to assess inflammatory response at 3, 6, and 13 weeks. The devices exhibited the same early and late osseointegration and/or early and late soft tissue attachment behavior.

In conclusion, the results of the non-clinical testing demonstrate that the TiUltra implants and Xeal abutments met the established performance specifications per intended use. The non-clinical testing also demonstrates that the Tilltra implants and Xeal abutments do not raise new questions of substantial equivalence when compared to the respective predicate devices.

Summary of Clinical Testing

No clinical studies submitted.

Real World Evidence (interim 18 month post market surveillance data in CE mark recognizing countries, a sponsor-investigator study in Italy, and five case studies with 3-5 month follow-ups) was provided to support the substantial equivalence. The prospective, single arm, sponsor-investigator study enrolled 61 patients. The patients received a single TiUltra implant and Xeal abutment in the posterior region of the maxilla or mandible. At the time of final prosthesis placement, on average 16.4 ± 7.3 weeks after implant placement, the patients showed successful soft tissue parameters (93%). implant survival (100%) and only one adverse event was reported due to a small dehiscence. The ability to receive the final prostheses, demonstrated there were no immediate adverse effects from the technological differences (i.e., multi-level anodization and soluble salt (protective) layer). Four patients had completed 1-year follow up radiographs and demonstrated stable bone levels further supporting the equivalent performance of the subject devices.

Conclusions

The TiUltra implants and Xeal abutments were evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics, non-clinical test data, and real world evidence provided in support of this 510(k), the TiUltra implants and Xeal abutments have been shown to be substantially equivalent to the predicate 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.