(68 days)
No
The summary describes a mechanical dental abutment system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used to anchor single tooth prostheses, which are used to restore the function and aesthetics of missing teeth, thus providing a therapeutic benefit to the patient.
No
Explanation: The device is an abutment system intended to anchor single tooth prostheses, not to diagnose a condition or disease.
No
The device description clearly states it is an "abutment used with an endosseous implant," which are physical components, not software.
Based on the provided information, the Nobelpharma CeraOne Abutment System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to anchor single tooth prostheses in partially edentulous patients. This is a surgical/dental procedure performed directly on the patient's body.
- Device Description: The device is an abutment used with an endosseous implant, which is implanted in the jaw bone. This is a physical component used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. The Nobelpharma CeraOne Abutment System is a medical device used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Nobelpharma CeraOne Abutment System is intended to be used to anchor single tooth prostheses in partially edentulous patients.
Product codes
Not Found
Device Description
The Nobelpharma CeraOne Abutment System is an abutment used with an endosseous implant which is implanted in the upper or lower jaw bone. The CeraOne System allows the prosthesis to be cemented directly to the abutment rather than requiring an additional screw connection. The modifications to the device are the broadening and narrowing of the base and external diameters of the abutments; and broadening and narrowing of the diameters of the abutment screws, adding two series of abutments fitting to larger and smaller diameters of fixtures previously cleared.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw bone
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
JUL 1 0 1996
Pre-Market Notification May 1, 1996 Page 2
510(k) Summary of Safety and Effectiveness VI.
A. Name and Address
This Summary of Safety and Effectiveness is being submitted by Nobelpharma USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. Their telephone number is (708) 654-9100. The contact person will be the Director, Regulatory Affairs. This summary was prepared on May 1, 1996.
B. Name of the Device
This device is known as an abutment to an endosseous implant with the trade name BRÅNEMARK SYSTEM® CeraOne Abutment System. This submission is a modification to a previously cleared device under K910611.
C. The Predicate Product
The predicate product used in this Premarket Notification is the previous version of the same device, CeraOne Abutment System, K910611.
D. Description of the Device
The Nobelpharma CeraOne Abutment System is an abutment used with an endosseous implant which is implanted in the upper or lower jaw bone. The CeraOne System allows the prosthesis to be cemented directly to the abutment rather than requiring an additional screw connection. The modifications to the device are the broadening and narrowing of the base and external diameters of the abutments; and broadening and narrowing of the diameters of the abutment screws, adding two series of abutments fitting to larger and smaller diameters of fixtures previously cleared.
E. Intended Use of the Device
The Nobelpharma CeraOne Abutment System is intended to be used to anchor single tooth prostheses in partially edentulous patients.
F. Comparison of Technological Characteristics
The technological characteristics between the modified version of the CeraOne Abutment and the earlier version are identical. The only changes are minor dimensional changes to the diameter of the abutment base and the abutment screw.