(29 days)
Not Found
No
The document describes a physical dental implant and its packaging, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is an implant surgically placed in the bone to provide support for prosthetic devices, restoring patient esthetics and chewing function, which are therapeutic effects.
No
The device is described as an endosseous dental implant intended to support prosthetic devices, not to diagnose medical conditions.
No
The device description clearly states it is a threaded, root-form titanium dental implant, which is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the NobelZygoma 0° implants are surgically placed in the bone to support prosthetic devices. They are a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is to restore patient esthetics and chewing function by providing support for artificial teeth. This is a structural and functional restoration, not a diagnostic process.
The information provided focuses on the physical characteristics of the implant, its surgical placement, and performance testing related to sterilization, packaging, and shelf life – all typical for a medical device intended for implantation, but not for an IVD.
N/A
Intended Use / Indications for Use
NobelZygoma 0° 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 NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper jaw arches, Zygomaticus bone, oral mucosa in the premolar region, sinus along the lateral wall of the maxilla, lateral maxillary wall
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)
Summary of Non-Clinical Testing:
The following verification/validation testing was performed on the modified implant packaging system. NobelZygoma 0° implant represents a worst case and data from the predicate device was leveraged to demonstrate substantial equivalence.
- Sterile Device Information
- The sterilization method of the subject device is the same as the predicate o device. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/SO 11137-1.2 & ISO 11737 1.2.
- Device Packaging .
- o The packaging for the subject device is modified from the predicate device. Therefore, package integrity test, sterilization and biocompatibility of packaging was performed in accordance to: ISO 11607-1and ASTM F2096.
- . Shelf Life
- o The packaging for the subject device is modified from that of the predicate with a 5-year expiration date labeled. Stability test - Accelerated aging was performed, on the new NobelZygoma 0° implant packaging composed of 3 packaging layers as per ASTM F1980, F2096 and ISO 11607-1 and real time aging is planned to validate 5 years expiration date.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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December 4, 2018
Nobel Biocare AB Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K183069
Trade/Device Name: NobelZygoma 0° Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: November 2, 2018 Received: November 5, 2018
Dear Charlemagne 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -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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Indications for Use
510(k) Number (if known)
Device Name NobelZygoma 0°
Indications for Use (Describe)
NobelZygoma 0° 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 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) | ☐ |
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3
510(k) Summary K183069
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: November 28, 2018
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
PREDICATE DEVICE
Primary predicate Nobel Biocare - NobelZygoma 0º (K161598)
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 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.
4
INDICATIONS FOR USE
NobelZygoma 0º 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 NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
| Characteristic | CANDIDATE | PREDICATE | Comparison | |
|---|---|---|---|---|
| NobelZygoma 0° | NobelZygoma 0° (K161598) | |||
| Features | Thread | |||
| Design | Single lead thread | Single lead thread | Same | |
| 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 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 | Same |
| | Implant Tip
Design | Tapered with cut out flutes. | Tapered with cut out flutes. | Same |
| | Implant
Length | 30, 35, 37.5, 40, 42.5, 45, 47.5, 50
mm | 30, 35, 37.5, 40, 42.5, 45, 47.5, 50
mm | Same |
| | Connection
Type | 0° straight, regular platform | 0° straight, regular platform | Same |
| | Platform
design | External hex, 4.5 mm | External hex, 4.5 mm | Same |
| | Device
Material | CP Titanium grade 4 (ASTM F67) | CP Titanium grade 4 (ASTM F67) | Same |
| | Surface | TiUnite | TiUnite | Same |
| 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. | Same |
| Indications for
Use | | NobelZygoma 0º 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 NobelZygoma Implants
are appropriate for immediate loading
when good primary stability is
achieved and with appropriate
occlusal loading | NobelZygoma 0º 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 NobelZygoma Implants
are appropriate for immediate loading
when good primary stability is
achieved and with appropriate
occlusal loading. | Same |
Comparison of Technological Characteristics
Nobel Biocare Special 510(k) Notification NobelZygoma 0° November 2018
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Analysis of Differences between Subiect Device and Predicate
The subject NobelZygoma 0° implant is same as the predicate device (K161598). The modification is made to the packaging of the subject device. The original shrink wrap and outer label on the vial is modified by adding a blister as a second sterile barrier and a carrier cardboard box for the label. The new NobelZygoma 0° implant packaging is composed of 3 packaging layers - tertiary packaging, secondary packaging and primary packaging. The subject device is not being modified.
The packaging modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. The intended use of the subject device, as described in its labeling, has not changed as a result of the packaging modifications.
PERFORMANCE DATA
Summary of Non-Clinical Testing:
The following verification/validation testing was performed on the modified implant packaging system. NobelZygoma 0° implant represents a worst case and data from the predicate device was leveraged to demonstrate substantial equivalence.
- Sterile Device Information
- The sterilization method of the subject device is the same as the predicate o device. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/SO 11137-1.2 & ISO 11737 1.2.
- Device Packaging .
- o The packaging for the subject device is modified from the predicate device. Therefore, package integrity test, sterilization and biocompatibility of packaging was performed in accordance to: ISO 11607-1and ASTM F2096.
- . Shelf Life
- o The packaging for the subject device is modified from that of the predicate with a 5-year expiration date labeled. Stability test - Accelerated aging was performed, on the new NobelZygoma 0° implant packaging composed of 3 packaging layers as per ASTM F1980, F2096 and ISO 11607-1 and real time aging is planned to validate 5 years expiration date.
CONCLUSIONS
The NobelZygoma 0° packaging system was evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics and non-clinical test data summarized in this submission, the subject NobelZygoma 0° has been shown to be substantially equivalent to the predicate NobelZygoma 0° Implant (K161598).