(278 days)
Nobel Biocare - NobelZygoma 45° (K152093)
No
The document describes a physical dental implant system and its components. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device (NobelZygoma implants) is intended to restore patient esthetics and chewing function by providing support for prosthetic devices, which qualifies it as a therapeutic device.
No
The device is an endosseous dental implant system (implants, abutments, and temporary coping) intended to provide support for prosthetic devices to restore esthetics and chewing function. It is a treatment device, not a diagnostic one.
No
The device description clearly details physical components (implants, abutments, copings) made of titanium, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the NobelZygoma implants are surgically placed in the bone to provide support for prosthetic devices. This is a surgical procedure and a physical implant, not a test performed on samples taken from the body.
- Device Description: The description details the physical characteristics of the implants and abutments, their materials, and how they are used in a surgical context. There is no mention of analyzing biological samples.
- Lack of IVD characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or screening.
The device is a medical device used for surgical implantation and prosthetic support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
NobelZygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
Nobel Biocare's NobelZygoma 0° implants are threaded, root-form titanium dental implants intended to be integrated in the Zygomaticus bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function.
The NobelZygoma 0° implants typically pierces the oral mucosa in the premolar region and passes through the sinus along the lateral wall of the maxilla. Depending on the contour of the lateral maxillary wall, the mid-portion of the implant may also pass lateral to the lateral wall.
The NobelZygoma 0° implants are available in lengths between 30 and 50 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.
Nobel Biocare's NobelZygoma 0° abutments are implant abutments intended to be used with the NobelZygoma 0° implant only.
The NobelZygoma 0° abutments are used to accommodate the total angle of the implant – abutment joint. This is necessary since the subject implant has a flat platform rather than the 45° platform of the predicate device implants.
The NobelZygoma 0° abutments are available in lengths between 6 and 10 mm and with angle of 45° or 60°. They contain the external hex connection and are made of a titanium alloy without any additional coating.
The Temporary Coping Multi-Unit and Temporary Coping Plastic Multi-unit are premanufactured dental abutment directly connected to the Multi-unit abutment. It is used as a temporary aid in prosthetic rehabilitation until the final restoration is attached. Maximum intraoral use is 180-days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper jaw arch (Zygomaticus bone, maxilla)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to establish that the NobelZygoma 0° will withstand foreseeable mastication forces.
No clinical data was used to support the decision of safety and effectiveness.
Summary of Non-Clinical Testing:
Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).
- Sterile Device Information:
- The sterilization method of the subject device is the same as the predicate device. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. The LAL testing information has been provided with this submission.
- Device Packaging:
- The packaging for the subject device is the same as the predicate device. This is a titanium cylinder placed in a plastic vial with PVC shrink-wrap and tamper resistant strip.
- Shelf Life:
- The packaging for the subject device is the same as the predicate and is labeled with a 5 year expiration date for implants and a 3 year expiration date for abutments. Accelerated aging was used to determine the expiration dating.
- Biocompatibility:
- The subject device is manufactured from the same material using the same manufacturing method as the predicate. Has the same intended use, and the same patient contact type and duration.
The fatigue limit of the NobelZygoma 0° was determined using a modified version of ISO 14801. The modifications to ISO 14801 were done to reflect the likely worst-case clinical use of the device. Both the subject and predicate device were tested under identical conditions. The results of the testing were used to address questions related to substantial equivalence based on difference in design between the subject and predicate devices.
Discussion of Non-Clinical data:
In order to assess the differences between the predicate device and subject device comparability testing and/or evaluations were performed as listed above. The data obtained concluded that the subject devices are considered to be substantially equivalent with the identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Nobel Biocare - NobelZygoma 45° (K152093)
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.
Nobel Biocare – Zygoma Angled Abutments (K052885), Nobel Biocare - Branemark System Zygomaticus Fixture System (K970499), Nobel Biocare - Zygoma Implant (K070182)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2017
Nobel Biocare AB c/o Mr. Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K161598
Trade/Device Name: NobelZygoma 0° Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 15, 2017 Received: February 16, 2017
Dear Mr. Chua:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K161598 |
|---|---|
| Device Name | NobelZygoma 0° |
| Indications for Use (Describe) | NobelZygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14) Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Pollow I nother con-
(USA) (UTCHES) (USE/LANDACTIO) (
三南川砂天
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l. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348
Date Prepared: March 13, 2017
II. DEVICE
Name of Device: NobelZygoma 0°
Common or Usual Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Primary Product Code: DZE Other Product Codes: NHA
III. PREDICATE DEVICE
Primary predicate Nobel Biocare - NobelZygoma 45° (K152093)
Reference predicates Nobel Biocare – Zygoma Angled Abutments (K052885) Nobel Biocare - Branemark System Zygomaticus Fixture System (K970499) Nobel Biocare - Zygoma Implant (K070182)
A.4
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IV. DEVICE DESCRIPTION
Implants:
Nobel Biocare's NobelZygoma 0° implants are threaded, root-form titanium dental implants intended to be integrated in the Zygomaticus bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function.
The NobelZvgoma 0° implants typically pierces the oral mucosa in the premolar region and passes through the sinus along the lateral wall of the maxilla. Depending on the contour of the lateral maxillary wall, the mid-portion of the implant may also pass lateral to the lateral wall.
The NobelZygoma 0° implants are available in lengths between 30 and 50 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.
Abutments:
Nobel Biocare's NobelZygoma 0° abutments are implant abutments intended to be used with the NobelZygoma 0° implant only.
The NobelZygoma 0° abutments are used to accommodate the total angle of the implant – abutment joint. This is necessary since the subject implant has a flat platform rather than the 45° platform of the predicate device implants.
The NobelZygoma 0° abutments are available in lengths between 6 and 10 mm and with angle of 45° or 60°. They contain the external hex connection and are made of a titanium alloy without any additional coating.
Temporary Coping Multi-Unit:
The Temporary Coping Multi-Unit and Temporary Coping Plastic Multi-unit are premanufactured dental abutment directly connected to the Multi-unit abutment. It is used as a temporary aid in prosthetic rehabilitation until the final restoration is attached. Maximum intraoral use is 180-days.
V. INDICATIONS FOR USE
NobelZygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices. such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygomalmplants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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VI. Comparison of Technological Characteristics Implants:
| characteristic | CANDIDATE | PREDICATE | |
|---|---|---|---|
| NobelZygoma 0° | NobelZygoma 45° (K152093) | ||
| Features | Thread Design | Single lead thread | Single lead thread |
| Implant Body Design | Parallel wall with 3 diameters transition |
- 4.5 mm at the platform
- 4.3 mm without thread at 9.5 mm from the platform
- 5.0 mm at the apex at 18 mm from the apex
Thread starts from the apex and extends for 18 mm | Parallel wall with 2 diameters transition at 2 mm from platform - 4.5 mm at the platform
- 3.9 mm at the apex
Threads starting at apex and extending 18 mm |
| | Implant Tip Design | Tapered with cut out flutes. | Tapered with cut out flutes. |
| | Implant Length | 30, 35, 37.5, 40, 42.5, 45, 47.5, 50 mm | 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5 mm |
| | Connection Type | 0° straight, regular platform | 45° angled, regular platform |
| | Restoration Capability | Fixed bar | Fixed Bar |
| | Platform design | External hex, 4.5 mm | External hex, 4.5 mm |
| | Device Material | CP Titanium grade 4 (ASTM F67) | CP Titanium grade 4 (ASTM F67) |
| | Surface | TiUnite | TiUnite |
| Intended Use/ Principles of Operation | | Nobel Biocare's Zygoma implants are endosseous implants and are integrated in the zygomatic bone (osseointegration). They are intended to be used for anchoring or supporting tooth replacements to restore chewing function. | Nobel Biocare's Zygoma implants are endosseous implants and are integrated in the zygomatic bone (osseointegration). They are intended to be used for anchoring or supporting tooth replacements to restore chewing function. |
| Indications for Use | | NobelZygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate | Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied. |
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| Abutments: | |||
|---|---|---|---|
| characteristic | CANDIDATE | PREDICATE | |
| Compatible Implant Platform | NobelBiocare: External Hex Regular Platform (RP) | NobelBiocare: External Hex Regular Platform (RP) | |
| Device material | Titanium-6 Aluminum-4 Vanadium alloy (ASTM F136) | Titanium-6 Aluminum-4 Vanadium alloy (ASTM F136) | |
| Features | Angulations | 45° and 60° | 0° and 17° |
| Available abutment length | 45°: 6mm, 8mm and 10mm | ||
| 60°: 6mm and 8mm | 0°: 3mm and 5mm | ||
| 17°: 2mm and 3mm | |||
| Abutment design | Single piece with fixed upper shape | Single piece with fixed upper shape | |
| Screw material | Titanium-6 Aluminum-4 Vanadium alloy (ASTM F136) | Titanium-6 Aluminum-4 Vanadium alloy (ASTM F136) |
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Analysis of Differences between Subject Device and Predicate
Implants:
The subject NobelZygoma 0° implants have a fundamentally similar design as the predicate NobelZygoma 45º Implants (K152093). The two implant designs share the same materials, manufacturing methods, tapered tip design with flutes, and use the TiUnite surface treatment. Additionally, the threads of the NobelZygoma 0° and predicate both start at the implant apex and extend 18 mm. Although the subject and predicate devices share many similarities, a number of design characteristics have been changed. These changes are listed below.
- The available lengths for the NobelZygoma 0° are slightly different from the predicate. NobelZygoma 0° are available in lengths between 30 and 50 mm. The predicate device is available between the lengths of 30 and 52.5 mm.
- -The profile of the NobelZygoma 0° is different from the predicate. Both implants are parallel walled. The NobelZygoma 0° have 3 diameters transition: 4.5 mm at the platform, 4.3 mm without thread at 9.5 mm at the platform and 5.0 mm at the apex at 18 mm from the apex. The predicate NobelZygoma 45º Implant is 4.5 mm at the platform and 3.9 mm at the apex.
- -The abutment connection of the NobelZygoma 0° is flat. The predicate has a 45° angulation. This change requires different abutments that can compensate for the lack of platform angulation. This change does not increase the amount of total angulation used and allows placement of the implant independent of the head rotation.
Abutments:
The subject NobelZygoma 0° abutments, as well as the predicate abutments, share the common tip design of multi-unit abutments. The NobelZygoma 0° abutments are co-packed an abutment screw. Both, predicate and subject abutments also share the same material composition and manufacturing methods. Although many similarities, the abutments differ in the following aspects:
- The abutment angle was increased to accommodate the flat implant head of the subject implant device.
- The abutment length was increased in tandem with the angle, because the subject abutment needs to mimic the predicate devices angled implant head with the predicate abutment attached to it.
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Summary:
These changes were made to modify the implant design to allow a more adaptable implant placement. The design changes to the abutment do not represent novel technologies and only of a kind to mimic the implant-abutment joint of the predicate device. Both, changes to subject implant and abutment accommodate each in other resulting in an implant-abutment joint which is similar to the implant-abutment joint of the predicates devices.
The Intended Use of the NobelZygoma 0° is substantially equivalent to the the NobelZygoma 45º (K152093, predicate). The change in the indication for use from "immediate function" to "immediate loading" better represents clinical experience and does not affect the intended use when compared to the predicate device.
The documentatjon submitted in the premarket notification demonstrates that the NobelZygoma 0° is substantially equivalent to the predicate device. Differences in technology were evaluated through comparative performance testing.
VII. PERFORMANCE DATA
Bench testing was performed to establish that the NobelZygoma 0° will withstand foreseeable mastication forces.
No clinical data was used to support the decision of safety and effectiveness.
Summary of Non-Clinical Testing:
Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).
- . Sterile Device Information
- o The sterilization method of the subject device is the same as the predicate device. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/SO 11137. The LAL testing information has been provided with this submission.
- Device Packaging
- o The packaging for the subject device is the same as the predicate device. This is a titanium cylinder placed in a plastic vial with PVC shrink-wrap and tamper resistant strip.
- Shelf Life ●
- o The packaging for the subject device is the same as the predicate and is labeled with a 5 year expiration date for implants and a 3
9
year expiration date for abutments. Accelerated aging was used to determine the expiration dating.
- Biocompatibility .
- · The subject device is manufactured from the same material using the same manufacturing method as the predicate. Has the same intended use, and the same patient contact type and duration.
The fatique limit of the NobelZygoma 0° was determined using a modified version of ISO 14801. The modifications to ISO 14801 were done to reflect the likely worst-case clinical use of the device. Both the subject and predicate device were tested under identical conditions. The results of the testing were used to address questions related to substantial equivalence based on difference in design between the subject and predicate devices.
Discussion of Non-Clinical data:
In order to assess the differences between the predicate device and subject device comparability testing and/or evaluations were performed as listed above. The data obtained concluded that the subject devices are considered to be substantially equivalent with the identified predicate devices ..
VIII. CONCLUSIONS
The NobelZygoma 0° was evaluated for substantial equivalence using standard and/or comparative testing. In cases where the NobelZygoma 0° could be shown to not represent a worst-case with respect to the Zygoma Implant, data from the predicate device was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the NobelZygoma 0° has been shown to be substantially equivalent to the NobelZygoma 45° Implant.