N1 TiUltra TCC Implant System
Device Facts
| Record ID | K211109 |
|---|---|
| Device Name | N1 TiUltra TCC Implant System |
| Applicant | Nobel Biocare Services AG |
| Product Code | DZE · Dental |
| Decision Date | Dec 21, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
Device Story
System comprises endosseous dental implants, site preparation tools (OsseoShapers), abutments, and screws. Implants feature Tri-oval Conical Connection (TCC) and tapered body. OsseoShapers prepare osteotomy at low speed (50 rpm) without irrigation. Abutments (Multi-unit, Universal, Temporary, Healing) support prosthetic restorations. Digital workflow integrates intra-oral scanners, CAD/CAM software, and milling units. Used by dental clinicians in clinics to restore chewing function and esthetics. Output is a stable foundation for prosthetic teeth. Benefits include restored function/esthetics and support for various loading protocols.
Clinical Evidence
Clinical evidence includes the retrospective, multi-center T-193 EVOLUTION Study (n=95 subjects, 165 implants) evaluating the N1 Concept System. Primary endpoint: Marginal Bone Level Change (MBLC) from loading to 12 months post-loading. Results showed increased bone (0.15 ± 0.84 mm), meeting non-inferiority to NobelActive (p<0.001). Secondary endpoints (survival, success, tissue health, safety) were clinically favorable. Supported by post-market surveillance, literature review, and clinical data gap analysis.
Technological Characteristics
Implants: Grade 4 CP Titanium (ASTM F67). Abutments/Screws: Ti-6Al-4V alloy (ASTM F136/ISO 5832-3). Surface: Anodic oxidation with soluble salt (protective) layer. Connection: Tri-oval Conical Connection (TCC). Workflow: Digital (Intra-oral scanner, CAD/CAM, milling). Sterilization: Gamma (SAL 10^-6). OsseoShapers: ISO 1797 Type 1/ISO 17509 compatible.
Indications for Use
Indicated for maxilla or mandible anchoring/supporting prosthetic teeth to restore esthetics and chewing function in partially or fully edentulous patients. Suitable for single or multiple unit restorations (splinted/non-splinted) using 1-stage or 2-stage surgical techniques with immediate, early, or delayed loading, provided sufficient primary stability and occlusal loading are achieved.
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)
Reference Devices
- TiUltra Implants and Xeal Abutments (K202344)
- NobelActive Wide Platform (WP) (K133731)
- On1 Concept (K161655)
- Branemark Novum (K000018)
- Universal Base Conical Connection (CC) (K200040)
- On1 Universal Abutment (K181869)
- Multi-unit Abutment Plus (K161416)
- Nobel Biocare Dental Implant Systems Portfolio - MR Conditional (K212125)
Related Devices
- K233896 — JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus · Jdentalcare Srl · Aug 16, 2024
- K163640 — QZA and RS Dental Implant Systems · Trinon Titanium GmbH · May 3, 2017
- K242753 — SD TL Implant System · Arum Dentistry Co., Ltd. · Jan 6, 2025
- K200329 — IDCAM Dental Implants · Implants Diffusion International · Apr 22, 2021
- K240837 — TOV Dental Implant System · Rdj Tov Implant, Ltd. · Aug 15, 2024
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). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
Nobel Biocare Services AG Bernice Jim Head of RA Product Development and Marketed Products Balz Zimmermann-Str. 7 Kloten, Zurich 8302 SWITZERLAND
Re: K211109
Trade/Device Name: N1TM TiUltra™ TCC Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA, PNP, QRQ Dated: November 18, 2021 Received: November 19, 2021
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K21109
#### Device Name
N1™ TiUltra™ TCC Implant system
#### Indications for Use (Describe)
N1™ TiUltra™ TCC Implant system
NI™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. NI™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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## Form 3881 (Cont.)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2023 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | |
| K211109 | |
| Device Name | |
| N1TM TiUltraTM TCC Implant system | |
| Indications for Use (Describe) (Cont.) | |
| Nobel Biocare N1TM TiUltraTM TCC implants | |
| N1TM TiUltraTM TCC Implant system is indicated for use in the maxilla or mandible for anchoring or<br>supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1TM<br>TiUltraTM TCC Implant system is indicated for single or multiple unit restorations in splinted or non-<br>splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate,<br>early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal<br>loading for the selected technique has been achieved. | |
| OsseoShaper 1 Nobel Biocare N1TM and OsseoShaper 2 Nobel Biocare N1TM | |
| The N1TM system Implant Site Preparation Tools are indicated to be used in the maxilla or mandible<br>to prepare an osteotomy prior to placement of a Nobel Biocare N1TM TiUltraTM TCC implant. | |
| Cover Screw Nobel Biocare N1TM TCC | |
| To be used when applicable together with the implant during healing in order to protect the implant<br>platform and internal threads from overgrowth of bone. | |
| Multi-unit Abutment Xeal Nobel Biocare N1TM TCC | |
| Multi-unit Abutment TCC is a premanufactured prosthetic component directly connected to the<br>endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. | |
| Universal Abutment Nobel Biocare N1TM TCC | |
| Universal abutments are indicated to support the placement of single unit, screw- retained prosthetic<br>restorations in the maxilla or mandible. | |
| The Universal Abutment consists of two major parts. Specifically, the titanium base and<br>mesostructure components make up a two-piece abutment. | |
| The system integrates multiple components of the digital dentistry workflow scan files from Intra-<br>Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated<br>tooling and accessories. | |
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#### Form 3881 (Cont.)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|----------------------------------|
| Food and Drug Administration | Expiration Date: 06/30/2023 |
| <b>Indications for Use</b> | See PRA Statement below. |
The Universal Abutment Nobel Biocare N1™ Base consist of three major parts. Specifically, the N1 Base Xeal, the Universal Abutment N1 Base, 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.
#### Nobel Biocare N1™ Base Xeal™
The Nobel Biocare N1™ Base Xeal™ is indicated for use in the maxilla or mandible for supporting tooth replacements to restore chewing function. It is indicated for single unit restorations and multiple unit restorations up to 6 units with less than 20° divergence to allow path of insertion.
#### Universal Abutment Nobel Biocare N1™ Base Tri
The Universal Abutment Nobel Biocare N1™ Base Tri is indicated to support the placement of single unit, screw-retained prosthetic restorations in the maxilla or mandible.
#### Universal Abutment Nobel Biocare N1™ Base Tri Bridge
The Universal Abutment Nobel Biocare N1™ Base Tri Bridge is indicated to support the placement of multiple unit of up to 6 units. screwretained prosthetic restorations in the maxilla or mandible for implants with less than 20° overall divergences to allow path of insertion.
#### Healing Abutment Nobel Biocare N1™ TCC
Healing abutments are indicated for use with endosseous dental implants in the maxilla or mandible for supporting single tooth to full arch denture procedures. Healing abutments Nobel Biocare N17M TCC are indicated for use for up to 180 days.
#### Temporary Abutment Nobel Biocare N1™ TCC
Are indicated for use with single unit screw-retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days.
#### Healing Abutment Nobel Biocare N1TM Base Tri
The Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days.
#### Temporary Abutment Nobel Biocare N1™ Base Tri
The Temporary Abutment Nobel Biocare N1™ Base is indicated to support the placement of single unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days.
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#### Form 3881 (Cont.)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|----------------------------------|
| Food and Drug Administration | Expiration Date: 06/30/2023 |
| Indications for Use | See PRA Statement below. |
Temporary Abutment Nobel Biocare N1TM Base (Bridge)
The Temporary Abutment Nobel Biocare N1™ Base Bridge is indicated to support the placement of multiple unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days for implants with less than 20° overall divergences to allow path of insertion.
IOS Healing Abutment Nobel Biocare N1™ Base Tri
The IOS Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days. In combination with intraoral scanner the IOS Healing Abutment can be used to confirm the location, position, and orientation of the Nobel Biocare N1™ Base Xeal™, to support creation of the digital model to facilitate the design and fabrication of a dental prosthesis using CAD/CAM.
Clinical Screw Nobel Biocare N1™ Base and Prosthetic Screw Nobel Biocare N1™ Base
The Clinical and Prosthetic Screw are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation.
Clin Screw Multi-unit Abut Nobel Biocare N1™ TCC and Clinical Screw Nobel Biocare N1™ TCC
Clinical Screws are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation.
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Image /page/6/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with the "TM" symbol in superscript.
#### 510(k) Notification K211109
#### Submitter:
Nobel Biocare AB P.O. Box 5190, 402 26 Västra Hamngatan 1 Goteborg, SE-411 17 Sweden
### Submitted by:
Nobel Biocare Services AG Balz Zimmermann-Str. 7 8302 Kloten Switzerland
| Contact Person: | Bernice Jim, Ph.D. |
|-----------------|-------------------------------------|
| E-Mail: | regulatory.affairs@nobelbiocare.com |
| Date Prepared: | 21 December 2021 |
#### Device:
| Trade Name: | N1™ TiUltra™ TCC Implant system |
|--------------------------|---------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Dental Implants |
| Regulation Name: | Endosseous Dental Implant |
| Regulation Number: | 21 CFR§872.3640 |
| Regulatory Class: | II |
| Product Code: | DZE |
| Secondary Product Codes: | NHA, PNP, QRQ |
#### Predicate Devices:
The predicate and reference devices used in this 510(k) submission are described in Table 5.1.
| | Table 5.1: Predicate and Reference Devices for the N1™ TiUltra™ TCC Implant system | | | |
|--------------|------------------------------------------------------------------------------------|--|--|--|
| (N1™ svstem) | | | | |
| | Device | 510(k) | Manufacturer |
|-------------------|--------------------------------------------------------------------|---------|------------------------|
| Primary Predicate | NobelActive | K142260 | Nobel Biocare AB |
| Reference #1 | TiUltra Implants and Xeal Abutments | K202344 | Nobel Biocare AB |
| Reference #2 | NobelActive Wide Platform (WP) | K133731 | Nobel Biocare AB |
| Reference #3 | On1 Concept | K161655 | Nobel Biocare AB |
| Reference #4 | Branemark Novum | K000018 | Nobel Biocare UAS Inc. |
| Reference #5 | Universal Base Conical Connection (CC) | K200040 | Nobel Biocare AG |
| Reference #6 | On1 Universal Abutment | K181869 | Nobel Biocare AB |
| Reference #7 | Multi-unit Abutment Plus | K161416 | Nobel Biocare AB |
| Reference #8 | Nobel Biocare Dental Implant Systems<br>Portfolio - MR Conditional | K212125 | Nobel Biocare AG |
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In compliance with the FDA Guidance Document entitled, "Bundling Multiple Devices or Multiple Indications in a Single Submission," issued June 22, 2007, Nobel Biocare has prepared a single submission for the N1™ TiUltra™ TCC Implant system because the submission represents a system of devices used together for a dental procedure which has similar supportive data, and one FDA review division will be involved.
### Device Description
N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws. Table 5.2 provides the Device Lines that when used together form the N1 TiUltra TCC Implant system.
| Subject Device | Item No. | Device Lines | Description |
|---------------------------------------|----------------------------------------------------|--------------------------------------------|----------------------------------|
| N1™ TiUltra™<br>TCC Implant<br>system | 1 | Nobel Biocare N1™ TiUltra™<br>TCC implants | Endosseous dental implant |
| | 2 | OsseoShaper | Instruments for bone preparation |
| 3 | Multi-unit Abutment Xeal™<br>Nobel Biocare N1™ TCC | Endosseous dental abutment | |
| 4 | Universal Abutments Nobel<br>Biocare N1™ | Endosseous dental abutment | |
| 5 | Temporary Abutments | Endosseous dental abutment | |
| 6 | Screws | Screws for endosseous dental<br>abutments | |
Table 5.2: Devices Included in this 510(k) Submission
The device description for the seven Device Lines are as follows:
## Nobel Biocare N1™ TiUltra™ TCC implants (Item 1):
N1 TiUltra TCC Implant system consists of a dental implant (i.e., Nobel Biocare N11" TiUltra™ TCC implants) featuring the Tri-oval Conical Connection (TCC), which is characterized by a tri-oval shaped coronal zone and a round, moderately tapered body. It is intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.
The Nobel Biocare N1 TiUltra TCC implants Device Line also includes the Cover Screw Nobel Biocare N1™ TCC ("Cover Screw"), which is a Device Component that covers the implant platform and prevents tissue overgrowth during the healing phase of the placed implant. The threaded portion of the Cover Screw fits inside the internal thread of the implant, while the head of the Cover Screw covers the inner surface of the implant (i.e., the implant connection).
### OsseoShaper (Item 2):
The OsseoShapers are rotating implant site preparation tools to be used at low speed (50rpm) without irrigation. The implant can be placed as soon as the OsseoShaper 1 Nobel Biocare N1™ ("OsseoShaper 1") has reached the desired depth and position in accordance with the preoperative planning at a torque value of <40 Ncm. The
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OsseoShaper 2 Nobel Biocare N1™ ("OsseoShaper 2") is intended to be used when the OsseoShaper 1 does not reach the desired depth and position in accordance with the preoperative planning and at a torque of <40 Ncm. The OsseoShapers work in conjunction with traditional implant placement accessories not subject to this submission (e.g., Guided Pilot Drill).
Multi-unit Abutment Xeal™ Nobel Biocare N1™ TCC (Item 3):
The Multi-unit Abutments Xeal™ Nobel Biocare N1™ TCC are transmucosal abutments used for multiple unit screw retained restorations. The Multi-unit Abutments Xeal Nobel Biocare N1 TCC are available in Narrow Platform (NP) and Regular Platform (RP), feature a tri-oval conical connection (TCC), and are compatible with the Nobel Biocare N1 TiUltra TCC implants.
### Universal Abutments Nobel Biocare N1™ (Item 4):
The Universal Abutment Nobel Biocare N1™ Device Line consists of the following Device Components:
- Universal Abutment Nobel Biocare N1™ TCC .
- Universal Abutment Nobel Biocare N1™ Base Tri ●
- Universal Abutment Nobel Biocare N1™ Base Tri (Bridge) ●
- Nobel Biocare N1™ Base Xeal™ TCC Tri .
The Universal Abutment Nobel Biocare N1™ Device Line are pre-manufactured dental implant abutments which can be either connected directly to a Nobel Biocare N1 TiUltra TCC implant, featuring the tri-oval conical connection, or to a Nobel Biocare N1 Base Xeal TCC Tri to support the placement of a screw-retained dental prosthesis.
The digital workflow requires the use of the following equipment and materials:
| Equipment / Material | Minimum Requirements |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scanner | Kavo LS3, 3Shape Trios, or other scanners with accuracy equal or higher than 6.9 µm |
| Design Software | DTX Studio Lab<br>(The Implant Libraries are automatically included in the software installer) or<br>3Shape Dental Designer<br>(The Implant Libraries are obtained via the 3Shape server in the software). |
| Restorative Material | Nacera Pearl Doceram Medical Ceramics<br>Minimum wall thickness allowed: $\leq$ 0.5 mm |
| Milling Unit | Roland DWX-52D |
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| Primer | Monobond Plus by Ivoclar Vivadent |
|--------------|--------------------------------------|
| Adhesive | Multilink Hybrid by Ivoclar Vivadent |
| Glycerin Gel | Liquid Strip by Ivoclar Vivadent |
The bonding procedure requires the use of following materials:
#### Temporary Abutments (Item 5):
The Temporary Abutments Device Line consists of the following abutments:
- Healing Abutment Nobel Biocare N1™ TCC ●
- Healing Abutment Nobel Biocare N1™ Base Tri ●
- Temporary Abutment Nobel Biocare N1™ TCC ●
- Temporary Abutment Nobel Biocare N1™ Base Tri ●
- Temporary Abutment Nobel Biocare N1™ Base (Bridge) ●
- IOS Healing Abutment Nobel Biocare N1™ Base Tri ●
The Healing Abutment Nobel Biocare N1 TCC and Healing Abutment Nobel Biocare N1 Base Tri are pre-manufactured dental implant abutments which can be either connected directly to a Nobel Biocare N1 TiUltra TCC implant, for the Healing Abutment Nobel Biocare N1 TCC, or to a Nobel Biocare N1 Base Xeal TCC Tri, for the Healing Abutment Nobel Biocare N1 Base Tri, to support healing of the surrounding soft tissue. The TCC connection interface is featured on the Healing Abutment Nobel Biocare N1 TCC, whereas the Healing Abutments Nobel Biocare N1 Base Tri feature the N1 1 Prosthetic Connection.
The Temporary Abutment Nobel Biocare N1 TCC is a pre-manufactured dental implant abutment which can be either connected directly to a Nobel Biocare N1 TiUltra TCC implant, for the Temporary Abutment Nobel Biocare N1 TCC, or to a Nobel Biocare N1 Base Xeal TCC Tri to support the placement of a temporary dental prosthesis. The Temporary Abutment Nobel Biocare N1 Base Tri and Temporary Abutment Nobel Biocare N1 Base (Bridge) are pre-manufactured dental implant abutments which are placed on top of the Nobel Biocare N1 Base Xeal TCC Tri to support the placement of a temporary dental prosthesis. The TCC connection interface is featured on the Temporary Abutment Nobel Biocare N1 TCC whereas the Temporary Abutment Nobel Biocare N1 Base Tri and Temporary Abutment Nobel Biocare N1 Base Tri (Bridge) feature the N1™ Prosthetic Connection.
The IOS Healing Abutment Nobel Biocare N1 Base Tri is a pre-manufactured dental implant abutment which can be connected to a Nobel Biocare N1 Base Xeal TCC Tri to support healing of the surrounding soft tissue and to facilitate the transfer of an intraoral location of the Nobel Biocare N1 Base Xeal TCC Tri from the patient's jaw to the relative position on a master cast in the dental laboratory using an intra-oral scanning procedure. The connection interface for the IOS Healing Abutment Nobel Biocare N1 Base Tri is the N1™ Prosthetic Connection.
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### Screws (Item 6):
The Nobel Biocare N1 TiUltra TCC Implant system contains the following abutment screws:
- Clin Screw Multi-unit Abut Nobel Biocare N1™ TCC ●
- Prosthetic Screw Nobel Biocare N1™ Base ●
- Clinical Screw Nobel Biocare N1™ Base .
- Clinical Screw Nobel Biocare N1™ TCC ●
Clinical and Prosthetic Screws of the N1 system are pre-manufactured dental implant screws designed to fix dental prostheses or dental implant system components such as implant abutments and implant healing abutments to an endosseous dental implant or to an endosseous dental abutment.
### Indications for Use:
### N1™ TiUltra™ TCC Implant system
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
### Nobel Biocare N1™ TiUltra™ TCC implants
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N11 TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
OsseoShaper 1 Nobel Biocare N1™ and OsseoShaper 2 Nobel Biocare N1™
The N1" system Implant Site Preparation Tools are indicated to be used in the maxilla or mandible to prepare an osteotomy prior to placement of a Nobel Biocare N1™ TiUltra™ TCC implant.
### Cover Screw Nobel Biocare N1™ TCC
To be used when applicable together with the implant during in order to protect the implant platform and internal threads from overgrowth of bone.
## Multi-unit Abutment Xeal Nobel Biocare N1™ TCC
Multi-unit Abutment TCC is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
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#### Universal Abutment Nobel Biocare N1™ TCC
Universal abutments are indicated to support the placement of single unit, screw- retained prosthetic restorations in the maxilla or mandible.
The Universal Abutment consists of two major parts. Specifically, the titanium base and mesostructure components make up a two-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.
The Universal Abutment Nobel Biocare N1™ Base consist of three major parts. Specifically, the N1 Base Xeal, the Universal Abutment N1 Base, 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.
#### Nobel Biocare N1™ Base Xeal™
The Nobel Biocare N1™ Base Xeal™ is indicated for use in the maxilla or mandible for supporting tooth replacements to restore chewing function. It is indicated for single unit restorations and multiple unit restorations up to 6 units with less than 20° divergence to allow path of insertion.
#### Universal Abutment Nobel Biocare N1™ Base Tri
The Universal Abutment Nobel Biocare N1™ Base Tri is indicated to support the placement of single unit, screw-retained prosthetic restorations in the maxilla or mandible.
#### Universal Abutment Nobel Biocare N1™ Base Tri Bridge
The Universal Abutment Nobel Biocare N1™ Base Tri Bridge is indicated to support the placement of multiple unit of up to 6 units, screwretained prosthetic restorations in the maxilla or mandible for implants with less than 20° overall divergences to allow path of insertion.
### Healing Abutment Nobel Biocare N1™ TCC
Healing abutments are indicated for use with endosseous dental implants in the maxilla or mandible for supporting single tooth to full arch denture procedures. Healing abutments Nobel Biocare N1™ TCC are indicated for use for up to 180 days.
### Temporary Abutment Nobel Biocare N1™ TCC
Are indicated for use with single unit screw-retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days.
#### Healing Abutment Nobel Biocare N1™ Base Tri
The Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days.
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### Temporary Abutment Nobel Biocare N1™ Base Tri
The Temporary Abutment Nobel Biocare N1™ Base is indicated to support the placement of single unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days.
#### Temporary Abutment Nobel Biocare N1™ Base (Bridge)
The Temporary Abutment Nobel Biocare N1™ Base Bridge is indicated to support the placement of multiple unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days for implants with less than 20° overall divergences to allow path of insertion.
#### IOS Healing Abutment Nobel Biocare N1™ Base Tri
The IOS Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days. In combination with intraoral scanner the IOS Healing Abutment can be used to confirm the location, position, and orientation of the Nobel Biocare N1™ Base Xeal™, to support creation of the digital model to facilitate the design and fabrication of a dental prosthesis using CAD/CAM.
#### Clinical Screw Nobel Biocare N1™ Base and Prosthetic Screw Nobel Biocare N1™ Base
The Clinical and Prosthetic Screw are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation.
#### Clin Screw Multi-unit Abut Nobel Biocare N1™ TCC and Clinical Screw Nobel Biocare N1™ TCC
Clinical Screws are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation.
#### Comparison of Technological Characteristics
#### Nobel Biocare N1 TiUltra TCC implants
The subject device, Nobel Biocare N1 TiUltra TCC implants have the same intended use and similar Indications for Use as NobelActive - K142260 (Primary Predicate) as the only difference is choice of similar wording. The Subject Device and Primary Predicate 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. Both devices have the same material and have the same surface treatment. In addition, both devices have the same range of implant lengths, implant diameters, and platform compatibility.
There are technological differences (i.e., connection interface, macro design, surface topography, surface preservation, Instructions for Use, and packaging) between the Nobel Biocare N1 TiUltra TCC implants, and the Primary Predicate, however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical and clinical testing.
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### Cover Screw
The Cover Screw has the same intended use and similar Indications for Use as the cover screws for NobelActive – K142260 (Primary Predicate), as the only differences are the choice of similar wording. Both devices are intended to be connected to a dental implant in order to protect the implant during the healing phase. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same material, gingival height, packaging, sterilization characteristics, and a similar range in diameters.
There are technological differences (i.e., design, connection interface and surface treatment) between the Cover Screw and the Primary Predicate however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical testing.
#### OsseoShapers
The OsseoShapers have the same intended use and similar Indications for Use as the Screw Tap from NobelActive – K142260 (Primary Predicate), as both devices are intended to be used to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The only differences are the choice of similar wording. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same tip design, are compatible with ISO 1797 Type 1 handpiece connections, have insertion depth markings, and use no irrigation during transient surgical use.
There are technological differences (i.e., design, materials and surface treatment, drill speed, reusability, and packaging) between the OsseoShapers and the Primary Predicate, however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical testing.
#### Multi-unit Abutment Xeal Nobel Biocare N1 TCC
The Multi-unit Abutment Xeal Nobel Biocare N1 TCC has the same intended use and Indications for Use as the Multi-unit Abutment Xeal™ from TiUltra Implants and Xeal Abutments - K202344 (Reference #1). Both abutment devices are premanufactured prosthetic components directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices are composed of the same material, have the same range of device lengths, widths, and platforms, and feature the Xeal surface with the soluble salt (protective) layer.
There is only one technological difference (i.e., connection interface) between the Multi-unit Abutment Xeal Nobel Biocare N1 TCC and Reference #1, however, this difference does not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical testing.
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### Universal Abutments Nobel Biocare N1 (UA N1)
The UA N1 has the same intended use as the On1 Base Xeal™ and Multi-unit Abutment Xeal™ from TiUltra Implants and Xeal Abutments – K202344 (Reference #1), the only difference is the choice of similar wording. Both devices are abutment components which are intended to be used with endosseous dental implants and be used as an aid in prosthetic rehabilitation. In addition, both devices have similar Indications for Use as it describes the number of abutment major parts and the associated workflow. Specifically, both Indications for Use indicate for one or more titanium base elements and mesostructure components making up a two- or multi-piece abutment. Further, both abutment systems integrate 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. The Indications for Use of Universal Base Conical Connection (CC) – K200040 (Reference #5) is also similar as it indicates for a two major part abutment with the same digital dentistry workflow. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same compatible implant platforms, titanium (Ti)-base material, abutment fixation, maximum abutment angulation, surface treatment, and abutment packaging.
There are technological differences (i.e., connection interface, abutment design, wall thickness circular/margin, abutment width, design workflow, manufacturing workflow, surface topography, surface preservation, and sterilization) between the UA N1 and Reference #1, however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical testing.
#### Temporary Abutments
The Temporary Abutments have the same intended use as the Healing Abutment Conical Connection WP and Temporary Snap Abutment Engaging Conical Connection WP from NobelActive Wide Platform (WP) - K133731 (Reference #2), as both abutment devices are premanufactured prosthetic components directly connected to an endosseous dental implant and or abutment base and is intended for use as an aid in prosthetic rehabilitation. In addition, the Indications for Use of the Temporary Abutments are similar to Reference #2 as both devices use similar wording. Temporary Abutments also include references to implant duration and digital workflows are represented in the Indications for Use of the On1 IOS Healing Cap from On1 Universal Abutment – K181869 (Reference #6) which has the same intended use as the Temporary Abutments and Reference #2. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same abutment diameter range, abutment angulation, packaging, and sterilization characteristics.
There are technological differences (i.e., material, post and gingival height, compatible implant platform, connection interface, and surface treatment) between the Temporary Abutments and Reference #2, however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical bench testing.
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#### Screws
The Screws have the same intended use as the On1™ Clinical Screw, and On1™ Prosthetic Screw from On1 Concept – K161655 (Reference #3), as they are all screws intended to secure dental abutments to dental implants, dental abutments to dental abutments, or dental abutments to final restoration. In addition, the Indications for Use are similar to Reference #3 and the same as the Clinical Screws MUA from Multi-unit Abutment Plus - K 161416 (Reference #7). The differences between the indications are a choice of similar wording. The differences do not affect the shared intended use between the devices. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same material, range of surface treatments, range of anatomical sites, packaging, and sterilization parameters.
There are technological differences (i.e., shaft diameter, total length, connection interface, abutment compatibility) between the Screws and Reference #3, however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical testing.
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## Substantial Equivalence Tables
| | Substantial Equivalence Table for N1 TiUltra TCC implants | | | |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device | Reference Device | |
| Technological<br>Characteristics | N1™ TiUltra™ TCC Implant<br>system | NobelActive - K142260 (Primary<br>Predicate) | TiUltra Implants and Xeal<br>Abutments - K202344 (Reference<br>#1) | Comparison |
| Device | Nobel Biocare N1™ TiUltra™ TCC<br>implants | NobelActive implants | NobelActive® TiUltra™ | |
| Pictorial Representation | Image: Nobel Biocare N1 TiUltra TCC implants | Image: NobelActive implants | Image: NobelActive TiUltra | -- |
| Regulatory Number/ Device<br>Classification Name | 21 CFR§872.3640<br>Endosseous dental implant | 21 CFR§872.3640<br>Endosseous dental implant | 21 CFR§872.3640<br>Endosseous dental implant | Same as the Primary Predicate. |
| Product Code | DZE | DZE | DZE | Same as the Primary Predicate. |
| Intended Use | Intended for use in the maxilla or<br>mandible for supporting dental<br>prostheses to restore patient<br>esthetics and chewing function. | NobelActive® implants are<br>endosseous implants intended to be<br>surgically placed in the upper or<br>lower jaw bone for anchoring or<br>supporting tooth replacements to<br>restore patient esthetics and chewing<br>function. | Nobel Biocare's TiUltra implants are<br>threaded, root-form dental implants<br>intended for use in the upper and/or<br>lower jaw to support prosthetic<br>devices, such as artificial teeth, in<br>order to restore patient esthetics and<br>chewing function to partially or fully<br>edentulous patients. | The same intended use as the Primary<br>Predicate expressed through a similar<br>choice of words. |
| Indications for Use | N1™ TiUltra™ TCC Implant system<br>is indicated for use in the maxilla or<br>mandible for anchoring or<br>supporting prosthetic teeth, in order<br>to restore patient esthetics and<br>chewing function. N1™ TiUltra™<br>TCC Implant system is indicated<br>for single or multiple unit<br>restorations in splinted or non-<br>splinted applications using a 2-stage | NobelActive® implants are<br>endosseous implants intended to be<br>surgically placed in the upper or<br>lower jaw bone for anchoring or<br>supporting tooth replacements to<br>restore patient esthetics and chewing<br>function.<br>NobelActive® implants are indicated<br>for single or multiple unit<br>restorations in splinted or | NobelActive TiUltra implants are<br>endosseous implants intended to be<br>surgically placed in the upper or<br>lower jaw bone for anchoring or<br>supporting tooth replacements to<br>restore patient esthetics and chewing<br>function.<br>NobelActive TiUltra implants are<br>indicated for single or multiple unit<br>restorations in splinted or | Similar Indications for Use as the<br>Primary Predicate expressed through a<br>similar choice of words. |
| Substantial Equivalence Table for N1 TiUltra TCC implants | | | | |
| | Subject Device | Predicate Device | Reference Device | |
| Technological<br>Characteristics | N1TM TiUltraTM TCC Implant<br>system | NobelActive - K142260 (Primary<br>Predicate) | TiUltra Implants and Xeal<br>Abutments - K202344 (Reference<br>#1) | Comparison |
| | or 1-stage surgical technique in<br>combination with immediate, early<br>or delayed loading protocols, given<br>that sufficient primary stability and<br>appropriate occlusal loading for the<br>selected technique has been<br>achieved. | non-splinted applications. This can<br>be achieved by a 2-stage or 1-stage<br>surgical technique in combination<br>with immediate, early or delayed<br>loading protocols, recognizing<br>sufficient primary stability and<br>appropriate occlusal loading for the<br>selected technique.<br>NobelActive® 3.0 implants are<br>intended to replace a lateral incisor in<br>the maxilla and/or a central or lateral<br>incisor in the mandible.<br>NobelActive® 3.0 implants are<br>indicated for single unit restorations<br>only. | non-splinted applications. This can<br>be achieved by a 2-stage or 1-stage<br>surgical technique in combination<br>with immediate, early or delayed<br>loading protocols, recognizing<br>sufficient primary stability and<br>appropriate occlusal loading for the<br>selected technique.<br>NobelActive TiUltra 3.0 implants are<br>intended to replace a lateral incisor in<br>the maxilla and/or a central or lateral<br>incisor in the mandible.<br>NobelActive TiUltra 3.0 implants are<br>indicated for single-unit restorations<br>only. | |
| Implant Length | 7.0, 9.0, 11.0, 13.0 mm | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0, 18.0<br>mm | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0, 18.0<br>mm | The range of implant lengths falls<br>within that of the Primary Predicate. |
| Implant Diameter | 3.5, 4.0 mm…
