(204 days)
No
The summary describes a CAD/CAM process for designing and manufacturing dental prosthetics, which is a standard digital workflow and does not mention or imply the use of AI or ML for tasks like image analysis, design optimization, or predictive modeling.
Yes
The device is described as an "aid in prosthetic rehabilitation" to restore "chewing function and esthetic appearance," which directly addresses a health-related condition (missing teeth) and improves the body's structure and function.
No
The device is described as a "patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment" and is "indicated for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance." It is a restorative component, not a device used to diagnose a medical condition.
No
The device description clearly states that the device is composed of physical components made of zirconia and titanium alloy, which are hardware. While software is used in the design and manufacturing process, the final medical device is a physical prosthetic component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "prosthetic rehabilitation" and "to restore chewing function and esthetic appearance." This describes a device used in vivo (within the body) to replace missing teeth and restore function, not a device used in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a dental prosthesis (abutment/implant crown and screw) that is connected to dental implants. This is consistent with a device used for dental restoration within a patient's mouth.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a dental prosthetic component, which falls under the category of medical devices used for treatment and restoration, not diagnosis.
N/A
Intended Use / Indications for Use
-
NobelProcera® Zirconia Abutment/Implant Crown N1™ Base:
The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation. -
Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:
The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.
Product codes
NHA
Device Description
NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) is composed of two subject device lines:
- NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and -
- -Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base
The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is a patient-matched specific CAD/CAM dental prosthesis which is connected to dental implants via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is available as device in two restorative design solutions as described following:
a) The Abutment design is intended to mimic a prepared tooth which is then finalized with a restoration
b) The Implant Crown design incorporates part or all of the final restoration (i.e. Crown) into its design
The abutment / implant crowns are manufactured from zirconia (Yttria stabilized tetragonal zirconia according to ISO 13356) and are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo approved dental scanner. The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base can be modeled with conventional impression, using a model to be scanned with a desktop scanner or directly with an intra oral scan with a Nobel Biocare/Kavo approved scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the abutment / implant crown is sent to the laboratory for finishing.
NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is provided with the required Prosthetic Screw, the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base which is a pre-manufactured dental prosthetic screw used to fasten the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base to a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri). The Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is made of titanium alloy according to ASTM F136 / ISO 5832-3.
The subject device lines are components of a two-piece abutment construct which consists of the Nobel Biocare N1™ Base Xeal™ TCC Tri (K211109) screw-retained using the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base (subject device line) to the NobelProcera® Zirconia Abutment / Implant Crown N1™ (subject device line).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing was performed on the Subject device lines NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base:
- Packaging system performance testing per ASTM D4169.
- Dynamic loading testing performed according to ISO 14801 was conducted according to ISO 14801 and the FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004). Testing also includes evaluation of the removal torque to assess if any screw-loosening of the run-out samples happened during ISO 14801 cyclic loading.
- Wear assessment of the titanium components/zirconia contact area:
- Assessment of all contacting surfaces of the subject device lines and the contacting surface of the Nobel Biocare N1 ™ Base Xeal™ TCC Tri using Light optical and SEM imaging following fatigue loading test according to ISO 14801 to demonstrate that the subject device lines present similar wear pattern in comparison with reference device systems (i.e. NobelProcera® Zirconia lmplant Bridge (K202452) and NobelProcera® ASC Abutment CC (K132746))
- In addition, real-world evidence on reference devices having DLC-coated prosthetic screw in contact with Zirconia abutments/restorations were reviewed. This real-world evidence according to the FDA Guidance Document entitled "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices" included the following:
- Post-Market Surveillance (PMS) data on NPr ASC Ab Zirconia CC (K132746), collected from December 2013 up to January 2022. In this data set, the longest possible time a Zirconia abutment with a DLC-coated Omnigrip Clinical Screw CC has been in a patient was approximately 8.1 years. The complaint rates were low and well within Nobel Biocare's predefined acceptance criteria and did not raise any concerns regarding the safety and effectiveness of utilizing dissimilar materials.
- Post-Market Surveillance (PMS) data for NobelProcera® Zr Implant Bridge (K202452), collected from May 2020 up to January 2022. In this data set, the longest possible time a Zirconia restoration has been in a patient was approximately 1.7 years. The complaint rates were low and well within Nobel Biocare's predefined acceptance criteria and did not raise any concerns regarding the safety and effectiveness of utilizing dissimilar materials.
- Clinical Data on NPr ASC Ab Zirconia CC, obtained from 5 clinical studies reporting on 277 NPr ASC Ab Zirconia CC (K132746) with reported mean follow ups ranging between a mean of 0.6 and 3.6 years. The studies were included consecutively with no selection regarding study inclusion made besides the inclusion criterion that the NPr ASC Ab Zirconia CC had to be used in the study. The clinical endpoints comprised relevant parameters such as soft and hard tissue health, and adverse events. There were no reports of any wear debris stemming from the Zirconia restoration / DLC-coated screw. Nor were other adverse events or other clinical outcomes reported that would raise different questions of safety and effectiveness, for devices using dissimilar materials.
- Clinical Data Gap Analysis – As all the clinical data presented is considered Real World Evidence, a gap analysis for each type of data was provided to demonstrate how the characteristics and evaluations of the real-world clinical evidence is relevant and reliable in order to support safety and effectiveness for devices using dissimilar materials.
- Magnetic Resonance compatibility testing according to ASTM F2052, ASTM F2213, ASTM F2119 and ASTM F2182.
- Verification of biocompatibility of the final device in accordance with ISO 10993-1.
- End user cleaning and sterilization validation in accordance with ISO 17665-1 and AAMI TIR12.
Key Metrics
Not Found
Predicate Device(s)
On1 Concept (K161655)
Reference Device(s)
N1™ TiUltra™ TCC Implant system (N1™ system; K211109), NobelProcera Angulated Screw Channel Abutment Conical Connection (K132746)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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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 Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Nobel Biocare Services AG Bernice Jim Head of RA Product Development and Marketed Products Balz Zimmermann-Str. 7 Kloten, Zurich 8302 SWITZERLAND
Re: K220048
Trade/Device Name: NobelProcera® Zirconia N1TM Base Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 29, 2022 Received: June 30, 2022
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 (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 mediation-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
2
Indications for Use
510(k) Number (if known) K220048
Device Name NobelProcera® Zirconia N1TM Base
Indications for Use (Describe)
· NobelProcera® Zirconia Abutment/Implant Crown N1™ Base:
The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation.
· Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:
The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside it. To the right of the square is the text "Nobel Biocare" in black font. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
510(k) Summary — K220048
NobelProcera® Zirconia N1™ Base
- Submitter Information
Submitter:
Nobel Biocare AB Vastra Hamngatan 1 Goteborg 411 17 Sweden
Submitted By:
Nobel Biocare Services AG Balz-Zimmerman-Strasse 7 8302 Kloten Switzerland
Contact Person: E-Mail: Prepared By: Date Prepared
Bernice Jim, Ph.D. regulatory.affairs@nobelbiocare.com Manfred Müller 29 July 2022
- Device Name
| Proprietary name: | NobelProcera® Zirconia N1™ Base |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
4
3. Predicate Device
| Primary Predicate | |
|---|---|
| Propriety Name: | On1 Concept (K161655) |
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Product Code: | NHA |
Reference Device No. 1
| Proprietary Name: | N1™ TiUltra™ TCC Implant system (N1™ system; K211109) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Implants |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | 21 CFR§872.3640 |
| Regulatory Class: | II |
| Product Code: | DZE, NHA, PNP, QRQ |
Reference Device No. 2
| Propriety Name: | NobelProcera Angulated Screw Channel Abutment Conical
Connection (K132746) |
|----------------------|-------------------------------------------------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Product Code: | NHA |
4. Device Description
NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) is composed of two subject device lines:
- NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and -
- -Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base
5
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 NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) because the submission covers several devices used together for a dental prosthetic procedure which has similar supportive data, and one FDA review division will be involved.
The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is a patient-matched specific CAD/CAM dental prosthesis which is connected to dental implants via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is available as device in two restorative design solutions as described following:
a) The Abutment design is intended to mimic a prepared tooth which is then finalized with a restoration
b) The Implant Crown design incorporates part or all of the final restoration (i.e. Crown) into its design
The abutment / implant crowns are manufactured from zirconia (Yttria stabilized tetragonal zirconia according to ISO 13356) and are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo approved dental scanner. The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base can be modeled with conventional impression, using a model to be scanned with a desktop scanner or directly with an intra oral scan with a Nobel Biocare/Kavo approved scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the abutment / implant crown is sent to the laboratory for finishing.
NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is provided with the required Prosthetic Screw, the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base which is a pre-manufactured dental prosthetic screw used to fasten the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base to a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri). The Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is made of titanium alloy according to ASTM F136 / ISO 5832-3.
The subject device lines are components of a two-piece abutment construct which consists of the Nobel Biocare N1™ Base Xeal™ TCC Tri (K211109) screw-retained using the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base (subject device line) to the NobelProcera® Zirconia Abutment / Implant Crown N1™ (subject device line).
6
Principle of Operation / Mechanism of Action
The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base are used for dental restoration purposes. The Zirconia abutments / implant crowns are mechanically connected to an endosseous implant via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) with the Subject Device line Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base to restore chewing function.
Patient Contacting Components
Following the assessment set forth in ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, Annex A, it was determined that the NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) device lines do contain patient contacting materials. The device component's categorization and contact duration and identification of material or color additive are listed in Table 1.
| Subject device lines | Device Category &
Contact Duration | Material & Surface Treatment
Description | Identification of Color
Additive |
|-----------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| NobelProcera® Zirconia
Abutment / Implant Crown N1 ™
Base | Permanent Implant Device
(>30 days) | Nacera Pearl: Yttria-stabilized
tetragonal zirconia (Y-TZP)
(according to ISO 13356) | No Color Additive |
| Prosthetic Screw
NobelProcera® Zr Nobel
Biocare N1™ Base | Permanent Implant Device
(>30 days) | Titanium vanadium alloy:
90% Ti, 6% Al, 4% V
(according to ASTM F136 / ISO
5832-3)
Diamond Like Carbon coating
(DLC) | No Color Additive |
Table 1: Patient Contacting Material List for NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) device lines
Compatible Devices and accessories:
The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is intended to be used with the following previously cleared or exempt accessories/devices from Nobel Biocare in Table 2 below. The subject device line Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is included in the table as well for the purpose of comprehensiveness.
7
Table 2: NobelProcera® Zr Nobel Biocare N1™ Base Device/Accessory compatibility overview
| Device /
Accessory | Nobel Biocare
N1TM Base XealTM
TCC Tri
(Article number) | Screw Driver
Machine
OmnigripTM Mini
(Article number) | Screw Driver
Manual
OmnigripTM Mini
(Article number) | Prosthetic screw
Nobel Procera® Zr
Nobel Biocare
N1TM Base
(Article number) | Lab Screw
NobelProcera® Zr
Nobel Biocare
N1TMBase
(Article number) | Base Replica
Nobel Biocare
N1TM Base Tri
(Article number) | IOS Base Replica
Nobel Biocare
N1TM Base Tri
(Article number) |
|-----------------------------------|------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------|
| Pictorial
Representation | | | | | | | |
| Article Numbers
(Platform: NP) | 300982, 300983;
300984 | 300852; 300853;
300854; | 300855; 300856 | 301031 | 301035 | 301021 | 301024 |
| Article Numbers
(Platform: RP) | 300985, 300986;
300987 | | | 301032 | 301036 | 301022 | 301025 |
| Manufacturer | Nobel Biocare | Nobel Biocare | Nobel Biocare | Nobel Biocare | Nobel Biocare | Nobel Biocare | Nobel Biocare |
| Classification | Class II | Class I | Class I | Class II | Class II | Class I | Class I |
| Regulation
Number | 872.3630 | 872.3980 | 872.3980 | 872.3630 | 872.3980 | 872.3980 | 872.3980 |
| Product Code | NHA, PNP | NDP | NDP | NHA | NDP | NDP | NDP |
| 510(k) | K211109 | Exempt | Exempt | n/a (Subject device
line) | Exempt | Exempt | Exempt |
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5. Indication for Use
NobelProcera® Zirconia Abutment / Implant Crown N1™ Base:
The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation.
Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:
The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.
6. Substantial Equivalence
a) Substantial Equivalence NobelProcera® Zirconia Abutment / Implant Crown N1™ Base
Details of the Similarities Between the Subject and Primary Predicate
The similarities between the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base (Subject Device) and the Primary Predicate, On1 Concept (K161655) as described in Table 3 below are as follows:
- The Intended Use and the Indications for Use is the same, expressed through a similar choice of words.
- The device design, the compatible Implant/Base platforms (NP/RP), the device connection/connector, the materials of the connector, the screw access and the device attachment method are identical for the Subject and Primary Predicate. Furthermore, both, the Subject and Primary Predicate are non-sterile, single-use devices. Additionally, the approach for biocompatibility and fatigue testing is the same for the Subject device and Primary Predicate.
Details of the Differences Between the Subject and Primary Predicate
There are no significant differences between the Subject and Primary Predicate but there are minor differences as follows:
- Both, the Subject device and the Primary Predicate utilizes a Ceramic material based on yttria-stabilized tetragonal zirconia (Y-TZP) for the abutment / implant crown material according to ISO 13356. However, for the Subject device a pre-sintered Zirconia milling disk "Nacera Pearl" (FDA cleared Zirconia material cleared under K143071) has been used which is also utilized for the mesostructure as part of Reference No. 1 (Universal Abutment Nobel Biocare N1™ Base Tri and Nobel Biocare N1™ Base Xeal™ TCC Tri as part of N1™ TiUltra™ TCC Implant system; K211109)
9
- The design methods including the angulated screw channel dimensions and device dimensions, manufacturing and packaging are similar to Reference Device No. 2. Both devices are patient-matched devices with an individualized emergence profile and shape design. Both devices feature an angulated screw channel with the same screw channel angulation range (0° - 25°).
- -The maximum device body angulation limits of the Subject device is similar to Reference Device No.1 and the difference is substantiated with fatigue testing.
- -However, the Subject device feature two design options, i.e. abutment design and implant crown design, whereas the Primary Predicate device feature only an abutment design option.
These minor differences do not raise new concerns of substantial equivalence. The comparison below (Table 3) for the Subject device, Primary Predicate and Reference Devices demonstrate that the Subject device is substantially equivalent to the Primary Predicate with regards to their Indications for use, technology and performance specifications.
The subject device furthermore does not introduce a fundamentally new scientific technology, and nonclinical performance testing demonstrates that the device is substantially equivalent. The performance testing described in this submission supports the conclusion that the Subject device performs as well as the Primary Predicate device for its intended use.
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| Subject device | Predicate device | Reference device | Reference device | |||
|---|---|---|---|---|---|---|
| Device Characteristics | NobelProcera® Zirconia | |||||
| Abutment / Implant Crown N1™ | ||||||
| Base | On1 Concept - K161655 | |||||
| (Primary Predicate) | N1™ TiUltra™ TCC Implant | |||||
| system (N1™ system) - | ||||||
| K211109 | ||||||
| (limited to Universal Abutment | ||||||
| Nobel Biocare N1™ Base Tri & | ||||||
| Nobel Biocare N1™ Base | ||||||
| Xeal™ TCC Tri) | ||||||
| (Reference Device No.1) | Nobel Procera Angulated | |||||
| Screw Channel Abutment | ||||||
| Conical Connection - K132746 | ||||||
| (Reference Device No. 2) | Comparison | |||||
| Device | NobelProcera® Zirconia | |||||
| Abutment / Implant Crown N1™ | ||||||
| Base | On1 Esthetic Abutment Zirconia | |||||
| On1 Base | Universal Abutment Nobel | |||||
| Biocare N1™ Base Tri | ||||||
| Nobel Biocare N1™ Base | ||||||
| Xeal™ TCC Tri | Nobel Procera Angulated Screw | |||||
| Channel Abutment Conical | ||||||
| Connections | ||||||
| Pictorial | ||||||
| Representation | Image: Implant Crown | |||||
| Image: Abutment | Image: On1 Esthetic Abutment Zirconia | |||||
| Image: On1 Base | Image: Universal Abutment Nobel Biocare N1 Base Tri | |||||
| (including mesostructure | ||||||
| (right)) | ||||||
| Image: Nobel Biocare N1 Base | ||||||
| Xeal TCC Tri | Image: Nobel Procera Angulated Screw | |||||
| Channel Abutment Conical | ||||||
| Connection with Adapter for | ||||||
| Zirconia Abutment Conical | ||||||
| Connection | ||||||
| Regulatory Classification | ||||||
| Regulatory Class | ||||||
| Reg. Number / | ||||||
| Classification name | Class II | Class II | Class II | Class II | Same as Primary Predicate | |
| Subject device | Predicate device | Reference device | Reference device | |||
| Device Characteristics | NobelProcera® Zirconia | |||||
| Abutment / Implant Crown N1 ™ | ||||||
| Base | On1 Concept - K161655 | |||||
| (Primary Predicate) | N1™ TiUltra™ TCC Implant | |||||
| system (N1 ™ system) - | ||||||
| K211109 | ||||||
| (limited to Universal Abutment | ||||||
| Nobel Biocare N1™ Base Tri & | ||||||
| Nobel Biocare N1 ™ Base | ||||||
| Xeal™ TCC Tri) | ||||||
| (Reference Device No.1) | Nobel Procera Angulated | |||||
| Screw Channel Abutment | ||||||
| Conical Connection - K132746 | ||||||
| (Reference Device No. 2) | Comparison | |||||
| 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 872.3630 | |||||
| Endosseous dental implant | ||||||
| abutment | ||||||
| Product Code | NHA | NHA | NHA, PNP | NHA | Same as Primary Predicate | |
| Indications for Use/Intended Use | ||||||
| Intended Use/ | ||||||
| Principles of operation | NobelProcera® Zirconia | |||||
| Abutment / Implant Crown N1 ™ | ||||||
| Base is a customized dental | ||||||
| prosthetic device which is seated | ||||||
| and attached directly to a dental | ||||||
| implant abutment to facilitate | ||||||
| restoration. | ||||||
| NobelProcera® Zirconia | ||||||
| Abutment / Implant Crown N1™ | ||||||
| Base is individually designed and | ||||||
| manufactured to fulfill the clinical | ||||||
| need of each patient. | The On1™ devices are | |||||
| intended for use in the field of | ||||||
| dentistry. They are intended to | ||||||
| be used in the upper or lower | ||||||
| jaw for supporting tooth | ||||||
| replacements to restore | ||||||
| chewing function and esthetics. | ||||||
| The On1™ esthetic abutments | ||||||
| in combination with the On1™ | ||||||
| Base on Nobel Biocare Conical | ||||||
| Connection endosseous | ||||||
| implants are indicated for | ||||||
| single-unit cement retained | Intended to be connected to an | |||||
| endosseous dental implant to | ||||||
| support the placement of a dental | ||||||
| prosthesis. | Nobel Biocare's | |||||
| NobelProcera® ASC Abutment | ||||||
| Zirconia is a customized dental | ||||||
| abutment. The abutment is | ||||||
| seated and attached directly to | ||||||
| the endosseous dental implant | ||||||
| and provides a platform for | ||||||
| restoration. | ||||||
| The NobelProcera® ASC | ||||||
| Abutment Zirconia is | ||||||
| individually designed and | ||||||
| manufactured to fulfill the | ||||||
| clinical need of each patient. | Same Indication for Use as Primary | |||||
| Predicate expressed through a | ||||||
| similar choice of words | ||||||
| NobelProcera® Zirconia | ||||||
| Abutment / Implant Crown N1 ™ | ||||||
| Base is made out of Zirconia and | ||||||
| is delivered with a Prosthetic | ||||||
| screw. | restorations. | The NobelProcera® ASC | ||||
| Abutment Zirconia is made out | ||||||
| of Zirconia and is delivered | ||||||
| with a titanium adapter and an | ||||||
| Omnigrip™ clinical screw. | ||||||
| Subject device | Predicate device | Reference device | Reference device | Comparison | ||
| Device Characteristics | NobelProcera® Zirconia | |||||
| Abutment / Implant Crown N1 ™ | ||||||
| Base | On1 Concept - K161655 | |||||
| (Primary Predicate) | N1™ TiUltra™ TCC Implant | |||||
| system (N1 ™ system) - | ||||||
| K211109 | ||||||
| (limited to Universal Abutment | ||||||
| Nobel Biocare N1™ Base Tri & | ||||||
| Nobel Biocare N1™ Base | ||||||
| Xeal™ TCC Tri) | ||||||
| (Reference Device No.1) | Nobel Procera Angulated | |||||
| Screw Channel Abutment | ||||||
| Conical Connection - K132746 | ||||||
| (Reference Device No. 2) | Comparison | |||||
| Indication for Use | The NobelProcera® Zirconia | |||||
| Abutment / Implant Crown N1 ™ | ||||||
| Base is a patient-matched | ||||||
| CAD/CAM prosthetic component | ||||||
| directly connected to an | ||||||
| endosseous dental implant | ||||||
| abutment with the Prosthetic | ||||||
| Screw and is indicated 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. | n/a | The NobelProcera Angulated | ||||
| Screw Channel Abutment Conical | ||||||
| Connection are premanufactured | ||||||
| prosthetic components directly | ||||||
| connected to endosseous dental | ||||||
| implants and is intended for use | ||||||
| as an aid in prosthetic | ||||||
| rehabilitation. | Same Indication for Use as Primary | |||||
| Predicate expressed through a | ||||||
| similar choice of words | ||||||
| Technological Characteristics | ||||||
| Device design | 2-piece abutment construct which | |||||
| consists of the N1 Base Xeal | ||||||
| TCC Tri (K211109) screw- | ||||||
| retained using the Prosthetic | ||||||
| Screw (subject device Table 4) to | ||||||
| the NobelProcera® Zirconia | ||||||
| Abutment / Implant Crown N1™ | ||||||
| Base component (subject device) | 2-piece abutment construct which | |||||
| consists of the On1 Base screw- | ||||||
| retained using the Prosthetic | ||||||
| Screw to the On1 Esthetic | ||||||
| Abutment. | 3-piece abutment construct which | |||||
| consists of the N1 Base Xeal | ||||||
| TCC Tri (K211109) screw- | ||||||
| retained using the Prosthetic | ||||||
| Screw to the N1 Universal Base | ||||||
| abutment and a cemented | ||||||
| retained implant crown portion | ||||||
| made of zirconium oxide. | 2-piece abutment construct which | |||||
| consists of the Nobel Procera | ||||||
| Angulated Screw Channel | ||||||
| Abutment made of zirconium | ||||||
| oxide screw-retained through the | ||||||
| titanium Adapter for Zirconia | ||||||
| Abutment Conical Connection | ||||||
| using the Omnigrip Clinical Screw | ||||||
| Conical Connection to the | ||||||
| implant. | Similar to Primary Predicate | |||||
| Compatible | ||||||
| Implant/Base platform | ||||||
| sizes | - Narrow Platform (NP) |
- Regular Platform (RP) | - Narrow Platform (NP)
- Regular Platform (RP)
- Wide Platform (WP) | - Narrow Platform (NP)
- Regular Platform (RP) | - Narrow Platform (NP)
- Regular Platform (RP) | Within the range of the Primary
Predicate | |
| Device connection /
connector | The NobelProcera® Zirconia
Abutment / Implant Crown N1 ™
Base component (subject device)
is connected to the N1 Base Xeal
TCC Tri (K211109) with the | The On1 Esthetic Abutment
Device is connected to the On1
Base with the On1 Prosthetic
Screw. | The mesostructure is cemented
on top of the Universal Abutment
Nobel Biocare N1™ Base and
connected to Nobel Biocare N1 ™
Base Xeal™ TCC Tri with the | The Nobel Procera Angulated
Screw Channel Abutment Conical
Connection is connected to
Adapter for Zirconia Abutment
Conical Connection with the | Same concept as Primary
Predicate | |
| Device Characteristics | Subject device | Predicate device | Reference device | Reference device | Comparison | |
| | NobelProcera® Zirconia
Abutment / Implant Crown N1 ™
Base | On1 Concept - K161655
(Primary Predicate) | N1™ TiUltra™ TCC Implant
system (N1™ system) -
K211109
(limited to Universal Abutment
Nobel Biocare N1™ Base Tri &
Nobel Biocare N1™ Base
Xeal™ TCC Tri)
(Reference Device No.1) | Nobel Procera Angulated
Screw Channel Abutment
Conical Connection - K132746
(Reference Device No. 2) | Comparison | |
| | Prosthetic Screw NobelProcera®
Zr Nobel Biocare N1™ Base
(subject device in Table 4). | Prosthetic Screw Nobel Biocare
N1™ Base. | Omnigrip Clinical Screw Conical
Connection. | | | |
| Connector material | Titanium vanadium alloy
MTA 005
(Ti6Al4V ELI, ASTM F136 / ISO
NOTE: Nobel Biocare N1 ™ Base
Xeal™ TCC Tri is not part of
subject device and only included
for illustration. This device has
been cleared by K211109 (N1™
TiUltra™ TCC Implant system
(N1™ system)), see Reference
device No. 1 | Titanium vanadium alloy
MTA 005
(Ti6Al4V ELI, ASTM F136 / ISO
5832) | Titanium vanadium alloy
MTA 005
(Ti6Al4V ELI, ASTM F136 / ISO
5832) | Titanium vanadium alloy
MTA 005
(Ti6Al4V ELI, ASTM F136 / ISO
5832) | Same as Primary Predicate | |
| Mesostructure/ Crown
material | Ceramic material based on yttria-
stabilized tetragonal zirconia (Y-
TZP)
Nacera® Pearl Shaded 16+2
(K143071) by Doceram Medical
Ceramics GmbH
Blank manufacturer: Doceram
Medical Ceramics GmbH
16+2 Shades (A1 to D2) | Ceramic material based on yttria-
stabilized tetragonal zirconia (Y-
TZP) | Ceramic material based on yttria-
stabilized tetragonal zirconia (Y-
TZP)
Nacera® Pearl Shaded 16+2
(K143071) by Doceram Medical
Ceramics GmbH
Blank manufacturer: Doceram
Medical Ceramics GmbH
16+2 Shades (A1 to D2) | Ceramic material based on yttria-
stabilized tetragonal zirconia (Y-
TZP)
Zirconia 4 shades (white-intense)
by Nobel Biocare
Blank manufacturer: Nobel
Biocare | Similar to Primary Predicate
Same as Reference Device No. 1 | |
| Device Characteristics | Subject device | Predicate device | Reference device | Reference device | | |
| | NobelProcera® Zirconia
Abutment / Implant Crown N1 ™
Base | On1 Concept - K161655
(Primary Predicate) | N1™ TiUltra™ TCC Implant
system (N1™ system) -
K211109
(limited to Universal Abutment
Nobel Biocare N1™ Base Tri & | Nobel Procera Angulated
Screw Channel Abutment
Conical Connection - K132746
(Reference Device No. 2) | Comparison | |
| | | | Nobel Biocare N1™ Base
Xeal™ TCC Tri)
(Reference Device No.1) | | | |
| | The chemical composition is
according to ISO 13356 "Implants
for surgery - Ceramic material
based on yttria-stabilized
tetragonal zirconia (Y-TZP) | The chemical composition is
according to ISO 13356 "Implants
for surgery - Ceramic material
based on yttria-stabilized
tetragonal zirconia (Y-TZP) | The chemical composition is
according to ISO 13356 "Implants
for surgery - Ceramic material
based on yttria-stabilized
tetragonal zirconia (Y-TZP) | 4 Zirconia shades (White to
intense).
The chemical composition is
according to ISO 13356 "Implants
for surgery - Ceramic material
based on yttria-stabilized
tetragonal zirconia (Y-TZP) | | |
| Screw access | Platform specific ø of the screw
hole and ASC
NP: 2.9 mm
RP: 3.1 mm | Platform specific ø of the screw
hole
NP/RP/WP: D2.44 mm
No ASC feature | Platform specific ø of the screw
hole
NP: D2.5 mm
RP: D2.7 mm
No ASC feature | Platform specific ø of the screw
hole and ASC
NP: D2.5 mm
RP: D2.65 mm | Similar to Primary Predicate | |
| Emergence profile | Individualized | Standardized | Mesostructure: Individualized | Individualized | Same as Reference Device No. 1 | |
| Individual shape
design | Individualized | Modifiable | Mesostructure: Individualized | Individualized | Same as Reference Device No. 1 | |
| Attachment method /
Device Fixation | Screw retained | Screw retained | Mesostructure: Cemented on
Universal Abutment Nobel
Biocare N1™ Base Tri | Screw retained | Same as Primary Predicate | |
| Angulated Screw
channel | Yes | No | No | Yes | Same as Reference Device No. 2 | |
| Device dimensions | Maximum:
● Diameter/width: 14.8
mm | Abutment Width at base
● 4.8, 5.3 and 6.5 mm | Device dimensions of
mesostructure: | Maximum (applicable for NP,
RP):
● Diameter: 20 mm | Similar to Reference devices | |
| | Subject device | Predicate device | Reference device | Reference device | | |
| Device Characteristics | NobelProcera® Zirconia
Abutment / Implant Crown N1TM
Base | On1 Concept - K161655
(Primary Predicate) | N1TM TiUltraTM TCC Implant
system (N1TM system) -
K211109
(limited to Universal Abutment
Nobel Biocare N1TM Base Tri &
Nobel Biocare N1TM Base
XealTM TCC Tri)
(Reference Device No.1) | Nobel Procera Angulated
Screw Channel Abutment
Conical Connection - K132746
(Reference Device No. 2) | Comparison | |
| | Height: 16.8 mm
Minimum:
NP:
Min. Post height: 4.2 mm Min. wall thickness: 0.4 mm RP:
Min. Post height: 4.2 mm Min. wall thickness: 0.4 mm | Combined base and post height
8.2 and 9.0 mm | Maximum (applicable for NP,
RP):
Diameter: n /a Height: 24.5 mm Minimum:
NP:
Min. Post height: 5.2 mm Min. wall thickness: 0.5 mm (circular) & 0.35 mm (margin) RP:
Min. Post height: 5.2 mm Min. wall thickness:
0.5 mm (circular) & 0.35 mm (margin) | Height: 20 mm
Minimum:
NP:
Min. Post height: 3.3 mm Min. wall thickness: 0.4mm RP:
Min. Post height: 3.1 mm Min. wall thickness: 0.4 mm | | |
| Screw channel
angulation | between 0° to 25° | n/a | n/a | between 0° to 25° | Same as Reference Device No. 2 | |
| Device Characteristics | Subject device | Predicate device | Reference device | Reference device | | |
| | Nobel Procera® Zirconia
Abutment / Implant Crown N1 ™
Base | On1 Concept - K161655
(Primary Predicate) | N1™ TiUltra™ TCC Implant
system (N1™ system) -
K211109
(limited to Universal Abutment
Nobel Biocare N1™ Base Tri &
Nobel Biocare N1™ Base
Xeal™ TCC Tri)
(Reference Device No.1) | Nobel Procera Angulated
Screw Channel Abutment
Conical Connection - K132746
(Reference Device No. 2) | Comparison | |
| | | | | | | |
| Maximum device body
angulation | Angulation depending on margin
height: | n/a | 20° | n/a | Similar to Reference Device No.1,
difference substantiated with
fatigue testing | |
| | Margin
height | Maximum
angulation
above
margin
height (soft
tissue height)
measured
from top of
the implant | | | | |
| | | [1] Greer, A.C., et al., Mechanical Complications Associated with Angled Screw Channel Restorations. Int J Prosthodont, 2017. 30(3): p. 258-259.
[2] Lv. X.-L., et al., Clinical, radiographic, and immunological evaluation of angulated screw-retained and cemented single-implant crowns in the esthetic region: A 1-year randomized clinical trial. Clinical Implant Dentistry and Related Research, 2021. 23(5): p. 692-702.
[3] Friberg, B. and M. Ahmadzai, A prospective study on single tooth reconstructions using parallel walled implants with internal connection (NobelParallel CC) and abutments with angulated screw channels (ASC). Clin Implant Dent Relat Res, 2019. 21(2): p. 226-231.
[4] Sanz-Martin, I., et al., Soft tissue augmentation at immediate implants using a novel xenogeneic collagen matrix in conjunction with immediate provisions: A prospective case series. Clin Implant Dent Relat Res, 2019. 21(1): p. 145-153.
[5] Fabbri, G., et al., Factors associated with prosthetic complications with individualized abutments: Real-world data [EAO-660], in European Association for Osseointegration Congress. accepted 2022: Geneva.
26
7. Conclusion
NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) consisting of the two subject device lines (NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base) are substantially equivalent to the Primary Predicate (On1 Concept – K161655) and Reference Devices (Universal Abutment Nobel Biocare N1™ Base Tri & Nobel Biocare N1™ Base Xeal™ TCC Tri as well as Prosthetic Screw Nobel Biocare N1 ™ Base as part of N1 ™ TiUltra™ TCC Implant system (N1 ™ system) - K211109)).