TiUltra Implants and Xeal Abutments

K202344 · Nobel Biocare AB · DZE · Nov 16, 2020 · Dental

Device Facts

• Record ID: K202344
• Device Name: TiUltra Implants and Xeal Abutments
• Applicant: Nobel Biocare AB
• Product Code: DZE · Dental
• Decision Date: Nov 16, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. 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 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 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 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. 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. 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 Story

Endosseous dental implants (TiUltra) and prosthetic abutments (Xeal); surgically placed in jaw bone to support tooth replacements; restore esthetics and chewing function. Implants feature internal conical connection with hex interface; titanium construction; multi-level anodized surface with hydrophilic soluble salt layer (sodium dihydrogen phosphate/magnesium chloride). Xeal abutments connect to implants to aid prosthetic rehabilitation; On1 Base Xeal integrates with digital dentistry workflow (intra-oral scanners, CAD/CAM software, milling). Used by dental surgeons/clinicians in clinical settings. Output provides stable platform for prosthetic crowns/bridges; facilitates osseointegration and soft tissue attachment; benefits patient through restored mastication and esthetics.

Clinical Evidence

No formal clinical trials submitted. Real-world evidence provided: prospective single-arm study (n=61) in posterior maxilla/mandible. Results: 100% implant survival, 93% successful soft tissue parameters at 16.4 weeks. One adverse event (dehiscence). Four patients showed stable bone levels at 1-year follow-up.

Technological Characteristics

Materials: Commercially pure titanium (implants), Titanium vanadium alloy (ASTM F1472, ASTM F136) (abutments). Surface: Anodic oxidation with multi-level topography and hydrophilic soluble salt layer (NaH2PO4·2H2O, MgCl2·6H2O). Connection: Internal conical with hex interface. Sterilization: Gamma radiation (SAL 10^-6). Connectivity: Integrates with digital dentistry workflow (DICOM/CAD/CAM).

Indications for Use

Indicated for patients requiring tooth replacement in upper or lower jaw; single or multiple unit restorations; splinted or non-splinted applications; 1-stage or 2-stage surgical techniques; immediate, early, or delayed loading protocols. NobelActive TiUltra 3.0 restricted to maxillary lateral incisors and mandibular central/lateral incisors. Contraindications include insufficient primary stability or inappropriate occlusal loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NobelActive (K142260)
• NobelReplace Hexagonal Implant (K073142)
• NobelParallel Conical Connection (K173418)
• Multi-unit Abutment Plus (K161416)
• On1 Universal Abutment (K181869)

Reference Devices

• BTI Dental Implant System UnicCa (K151391)
• ST Internal Implant System (K192347)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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.

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

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.

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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: | [e-mail] |
| Phone Number: | ([phone] |
| Fax Number: | ([phone] |
| 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 and<br>Reference #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

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.

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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® Conical<br>Connection (CC) TiUltra™ | Endosseous dental implant |
| | NobelParallel™Conical<br>Connection (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

| Subject<br>Device | Implant<br>Lines | Platform | Diameter (mm) | Length (mm) |
|---------------------|-----------------------------|----------|---------------|---------------------------------------|
| TiUltra<br>implants | NobelActive<br>TiUltra | 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 |
| | NobelReplace<br>CC 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 |
| | NobelParallel<br>CC 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

| Subject<br>Device | Abutment Line | Abutment Angle | Platform | Collar Height (mm) |
|-------------------|--------------------------------------|----------------|----------|--------------------|
| Xeal<br>abutments | Multi-unit<br>Abutment Xeal<br>(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 |
| Xeal<br>abutments | 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 the<br>implant | 20° Max |
| Wall Thickness Circular | 0.8mm min. |
| Wall Thickness Margin | 0.275mm min. |
| Post Height | 5.2mm min. |
| Maximum Length, width and<br>Height | EM-14 blank 12x14x18mm<br>EM-10 blank 8x10x15mm |

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#### Indications for Use

## NobelActive TiUltra

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.

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 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 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

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

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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 Device<br>TiUltra Implants | Predicate Device<br>NobelActive<br>(K142260 – Primary<br>Predicate) | Predicate Device<br>NobelReplace Hexagonal<br>Implant<br>(K073142 – Predicate #2) | Predicate Device<br>NobelParallel Conical<br>Connection<br>(K173418 – Predicate #3<br>and Reference #2)1 | Reference Device<br>BTI Dental Implant<br>System UnicCa®<br>(K151391 – Reference<br>#1) | Comparison | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | | | | | | | |
| Pictorial<br>Representation | Image: NobelActive TiUltra | Image: NobelActive | Image: NobelReplace Hexagonal Implant | Image: NobelParallel Conical Connection | N/A | -- | |
| | Image: NobelReplace CC TiUltra | | | | | | |
| | Image: NobelParallel CC TiUltra | | | | | | |
| Regulatory<br>Classification | 21 CFR 872.3640<br>Endosseous dental implant | 21 CFR 872.3640<br>Endosseous dental implant | 21 CFR 872.3640<br>Endosseous dental implant | 21 CFR 872.3640<br>Endosseous dental implant | 21 CFR 872.3640<br>Endosseous dental implant | All devices have the<br>regulatory classification, 21 | |
| Technological<br>Characteristics | Subject Device<br>TiUltra Implants | Predicate Device<br>NobelActive<br>(K142260 - Primary<br>Predicate) | Predicate Device<br>NobelReplace Hexagonal<br>Implant<br>(K073142 - Predicate #2) | Predicate Device<br>NobelParallel Conical<br>Connection<br>(K173418 - Predicate #3<br>and Reference #2)1 | Reference Device<br>BTI Dental Implant<br>System UnicCa®<br>(K151391 - Reference<br>#1) | Comparison | |
| | | | | | | CFR 872.3640, Endosseous<br>dental implant. | |
| Product Code | DZE | DZE, NHA | DZE | DZE | DZE…