(90 days)
No
The summary describes dental implants and abutments, focusing on materials, surgical techniques, and mechanical/biological performance. There is no mention of AI or ML in the intended use, device description, or performance studies. The digital dentistry workflow mentioned for the On1 Base Xeal refers to standard CAD/CAM processes, not AI/ML.
Yes
The device is described as an endosseous implant intended to be surgically placed for anchoring or supporting tooth replacements and prosthetic devices to restore patient esthetics and chewing function, which qualifies it as a therapeutic device.
No
Explanation: The provided text describes dental implants and prosthetic components used to restore patient esthetics and chewing function. There is no mention of the device being used to diagnose a medical condition or disease.
No
The device description clearly states that the devices are "endosseous dental implants and abutments," which are physical hardware components intended for surgical implantation. The summary details mechanical testing, sterilization, and biocompatibility, all related to physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices 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." This describes a surgical implant for structural support within the body.
- Device Description: The device description confirms they are "endosseous dental implants and abutments" made of titanium, designed for surgical placement and prosthetic support.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples or diagnostic purposes.
- Performance Studies: The performance studies focus on sterilization, biocompatibility, mechanical testing, and animal/clinical studies related to surgical implantation, osseointegration, and soft tissue attachment. These are typical evaluations for implantable devices, not IVDs.
Therefore, the NobelActive TiUltra, NobelReplace CC TiUltra, NobelParallel CC TiUltra implants, and the MUA Xeal and On1 Base Xeal abutments are classified as dental implants and prosthetic components, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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 and ANSI/AAMI ST72:2011/ (R)2016.
- Study Type: Packaging performance testing
- Sample Size: Not specified
- Key results: Conducted according to ISO 11607-1:2019, meeting requirements for materials, sterile barrier systems, and packaging systems.
- Study Type: Biocompatibility
- Sample Size: Not specified
- Key results: Conducted according to ISO 10993-1:2018, including expert toxicity assessment, dissolution kinetics, chemical characterization (ISO 10993-18:2009), cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010), irritation (ISO 10993-10:2010), material mediated pyrogenicity (ISO 10993-11:2017), acute systemic toxicity (ISO 10993-11:2017), and local effects after implantation (ISO 10993-6:2016).
- Study Type: Mechanical Testing
- Sample Size: Not specified
- Key results: Conducted according to ISO 14801:2016 and FDA Guidance Document, demonstrating assessment of implant-to-abutment connection platforms for wear of the anodized surface.
- Study Type: Modified surface treatment characterization
- Sample Size: Not specified
- Key results: Conducted according to FDA Guidance Document ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutment" (May 12, 2004)), including hydrophilicity (contact angle) and conductivity (salt amount) testing.
- Study Type: Animal Study (comparative)
- Sample Size: Not specified (Yucatan mini-pig model)
- Key results: 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. Devices exhibited same early and late osseointegration and/or early and late soft tissue attachment behavior.
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.
- Study Type: Sponsor-investigator study (prospective, single arm)
- Sample Size: 61 patients
- Key results: Patients received a single TiUltra implant and Xeal abutment in the posterior region of the maxilla or mandible. At final prosthesis placement (average 16.4 ± 7.3 weeks after implant placement), patients showed successful soft tissue parameters (93%), implant survival (100%), and only one adverse event due to small dehiscence. Ability to receive final prostheses demonstrated no immediate adverse effects from technological differences. Four patients with 1-year follow-up radiographs showed stable bone levels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Testing: Successful soft tissue parameters (93%), implant survival (100%).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K142260, K073142, K173418, K161416, K181869
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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.
5
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 and | |||
| 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.
6
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 | ||
| Connection (CC) TiUltra™ | Endosseous dental implant | |
| NobelParallel™Conical | ||
| 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
Device | Implant
Lines | Platform | Diameter (mm) | Length (mm) |
|---------------------|-----------------------------|----------|---------------|---------------------------------------|
| TiUltra
implants | NobelActive
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
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
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
| Device | Abutment Line | Abutment Angle | Platform | Collar Height (mm) |
|---|---|---|---|---|
| Xeal | ||||
| abutments | Multi-unit | |||
| Abutment 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 | |||
| Xeal | ||||
| 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
7
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 | |
| implant | 20° Max |
| Wall Thickness Circular | 0.8mm min. |
| Wall Thickness Margin | 0.275mm min. |
| Post Height | 5.2mm min. |
| Maximum Length, width and | |
| Height | EM-14 blank 12x14x18mm |
| EM-10 blank 8x10x15mm |
8
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 ' NobelParallel Concal Connection K173418 is Pedical CC Tilltra(subject device) and Reference #2 br NobelAcive and NobelReplace CC TiUlta(subject devices)
11
12
13
14
15
16
| Table 5: Comparison of the TiUltra implants with Predicate Implants (Cont.) | ||
|---|---|---|
2 Sq: Root Square Mean Roughness.
3 Sdr= Developed surface.
17
| Technological
Characteristics | Subject Device
TiUltra Implants | Predicate Device
NobelActive
(K142260 – Primary
Predicate) | Predicate Device
NobelReplace Hexagonal
Implant
(K073142 – Predicate #2) | Predicate Device
NobelParallel Conical
Connection
(K173418 – Predicate #3
and Reference #2)¹ | Reference Device
BTI Dental Implant
System 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 sterilized
with Gamma Radiation (SAL
$1x10^{-6}$ ). |
18
510(k) SUMMARY
| Technological
Characteristics | Subject Device
Xeal abutments | Predicate Device
Multi-unit Abutment
Plus (K161416 –
Predicate #4) | Predicate Device
On1 Universal Abutment
(Base)
(K181869 – Predicate #5) | Reference Device
EZ Post Abutment for
ST Internal Implant
System (K192347 –
Reference #3) | Reference Device
BTI Dental Implant
System UnicCa®
(K151391 – Reference
#1) | Comparison |
|----------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Pictorial Representation | Multi-unit Abutment
Xeal
Image: Multi-unit Abutment Xeal | Image: Multi-unit Abutment Plus | Image: On1 Universal Abutment and On1 Base | Image: EZ Post Abutment | N/A | |
| Regulatory
Classification | 21 CFR 872.3630
Endosseous dental
implant abutment | 21 CFR 872.3630
Endosseous dental
implant abutment | 21 CFR 872.3630
Endosseous dental
implant abutment | 21 CFR 872.3640
Endosseous dental
implant | 21 CFR 872.3640
Endosseous dental
implant | The subject and predicate devices
have the regulatory classification,
21 CFR 872.3630, Endosseous
dental implant abutment. |
| Product Code | NHA | NHA | NHA, PNP | DZE, NHA | DZE | The subject and predicate devices
have the product code, NHA. |
Table 6: Comparison of the Xeal abutments with Predicate Devices
19
| Technological
Characteristics | Subject Device
Xeal abutments | Predicate Device
Multi-unit Abutment
Plus (K161416 –
Predicate #4) | Predicate Device
On1 Universal Abutment
(Base)
(K181869 – Predicate #5) | Reference Device
EZ Post Abutment for
ST Internal Implant
System (K192347 –
Reference #3) | Reference Device
BTI Dental Implant
System UnicCa®
(K151391 – Reference #1) | Comparison | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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 Scanners, CAD
software, CAM software,
ceramic material, milling
machine and associated
tooling and accessories. | The Multi-unit Abutment
Plus is a pre-
manufactured prosthetic
component directly
connected to the
endosseous dental implant
and is intended for use as
an aid in prosthetic
rehabilitation. | The On1™ 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, 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. | The ST Internal Implant
System is intended to be
surgically placed in the
maxillary or mandibular
arches for the purpose
providing prosthetic
support for dental
restorations (Crown,
bridges, and
overdentures) in partially
or fully edentulous
individuals. It is used to
restore a patient's
chewing function.
Smaller implants (less
than 6.0mm) are
dedicated for immediate
loading when good
primary stability is
achieved and with
appropriate occlusal
loading. Larger implants
are dedicated for the
molar region and are
indicated for delayed
loading. | The BTI Dental Implant
System UnicCa® for
oral implant surgery is to
be used for the partial or
total replacement of teeth
in edentulate patients.
Once attached to the
bone, the implants act as
an anchor for various
fixed or removable
prosthetic solutions that
can be used to improve
or restore a patient's
mastication function.
In the case of 5.5 –
6.5mm long UnicCa®
implants should be used
in a two-stage surgical
procedure. These
implants are indicated
for delayed loading.
These implants are
indicated only for
straight abutments and to
support permanently
fixed restorations.
In the case of Tiny® 3.0
UnicCa® implants:
These implants shall be
used only to replace
maxillary lateral incisors
and mandibular lateral
and central incisors.
Immediate loading is
recommended when
there is good primary
stability and an
appropriate occlusal
load | MUA Xeal has the same
Indications for Use as Multi-unit
Abutment Plus (K161416 –
Predicate #4).
On1 Base Xeal has the same
Indications for Use as On1
Universal Abutment (Base)
(K181869 – Predicate #5). | |
| | | Subject Device
Xeal abutments | Predicate Device
Multi-unit Abutment
Plus (K161416 –
Predicate #4) | Predicate Device
On1 Universal Abutment
(Base)
(K181869 – Predicate #5) | Reference Device
EZ Post Abutment for
ST Internal Implant
System (K192347 –
Reference #3) | Reference Device
BTI Dental Implant
System UnicCa®
(K151391 – Reference
#1) | Comparison |
| | Technological
Characteristics | | | | | | |
| Design
Features | Compatible
Implants
Platforms | Nobel Biocare Internal
Conical Connection
• Narrow Platform (NP)
• Regular Platform (RP)
• Wide Platform (WP) | Nobel Biocare Internal
Conical Connection
• Narrow Platform (NP)
• Regular Platform (RP)
• Wide Platform (WP) | Nobel Biocare Internal
Conical Connection
• Narrow Platform (NP)
• Regular Platform (RP)
• Wide Platform (WP) | Hex, Non-Hex | N/A | The subject and predicate devices
are compatible with the NP, RP,
and WP implant platforms. |
| | Abutment
Height | MUA Xeal
1.5, 2.5, 3.5, 4.5mm
On1 Base Xeal
Combined base and post
height
• 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 post
height
• 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, 7.0mm
Gingival Height:
1.0, 2.0, 3.0, 4.0, 5.0mm | N/A | MUA Xeal has the same abutment
height as Multi-unit Abutment
Plus (K161416 – Predicate #4).
On1 Base Xeal has the same
abutment height as On1 Universal
Abutment (Base) (K181869 –
Predicate #5). |
| | Abutment
Width | MUA Xeal
4.8mm
On1 Base Xeal
At 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 abutment
width as Multi-unit Abutment
Plus (K161416 – Predicate #4).
On1 Base Xeal has the same
abutment width as On1 Universal
Abutment (Base) (K181869 –
Predicate #5). |
| | Abutment
Angulation | MUA Xeal
0°, 17°, 30°
On1 Base Xeal
0° angulation of the Base -
0-20° angulation of the
ceramic mesostructure | 0°, 17°, 30° | No abutment angulation | 0° | N/A | MUA Xeal has the same abutment
angulation as Multi-unit Abutment
Plus (K161416 – Predicate #4).
On1 Base Xeal has the same
abutment angulation as On1
Universal Abutment (Base)
(K181869 – Predicate #5). |
| | Material | Titanium vanadium alloy
(ASTM F1472, ASTM
F136) | Titanium vanadium alloy
(ASTM F1472, ASTM
F136) | Titanium vanadium alloy
(ASTM F1472, ASTM
F136) | Ti-6A1-4V ELI | Commercially Pure
Titanium | The material used for the subject
and predicate devices is Titanium
vanadium alloy (ASTM F1472,
ASTM F136). |
| Technological
Characteristics | Subject Device
Xeal abutments | Predicate Device
Multi-unit Abutment
Plus (K161416 –
Predicate #4) | Predicate Device
On1 Universal Abutment
(Base)
(K181869 – Predicate #5) | Reference Device
EZ Post Abutment for
ST Internal Implant
System (K192347 –
Reference #3) | Reference Device
BTI Dental Implant
System UnicCa®
(K151391 – Reference
#1) | Comparison | |
| Abutment
Surface
Treatment | Anodization | No surface treatment | No surface treatment | Anodization | N/A | The subject devices and EZ Post
Abutment for ST Internal Implant
System (K192347 – Reference #3)
have an anodization surface
treatment. The differences do not
raise different questions of
substantial equivalence as
demonstrated by bench testing. | |
| Abutment
Surface
Topography | Xeal – Single level
surface
• Sa, 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.
23
- 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.