(248 days)
No
The summary describes a system of physical components (implants, drills, instruments) for dental surgery and makes no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "endosseous implant" that provides support for "prosthetic devices such as artificial teeth" and "restores the patient's chewing function," which are therapeutic benefits.
No
The device is described as an endosseous implant system used to provide support for prosthetic devices and restore chewing function, not to diagnose a condition.
No
The device description explicitly lists physical components such as "Fixtures, Drills, Hand Instruments, Cover Screws and Accessories," indicating it is a hardware-based medical device system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an endosseous implant intended to be placed in the upper jaw arch to support prosthetic devices and restore chewing function. This is a surgical implant used directly within the body, not a test performed on a sample outside the body.
The information provided about the device's components (fixtures, drills, hand instruments, etc.) further reinforces that it is a surgical and prosthetic system, not an IVD.
N/A
Intended Use / Indications for Use
The Nobel Biocare BRANEMARK SYSTEM® Zygomaticus Fixture System is intended to be used as an endosseous implant to be surgically placed in the upper jaw to support prosthetic devices such as artificial teeth and to restore a patient's chewing function. (from 510k Summary)
The Nobel Biocare Branemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories. (from Indications for Use statement)
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
This device consists of fixtures and numerous components to be used in conjunction with the BRÅNEMARK SYSTEM® Zygomaticus Fixture System, including Fixtures, Drills, Hand Instruments, Cover Screws and accessories specific to the Zygomaticus Fixture System.
The Nobel Biocare BRANEMARK SYSTEM® Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover screws and accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper jaw arch / upper jaw
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): 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.
K925762, K925770, K925775, K925771, K925774, K925483, K953774, K951510
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.
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
OCT 1 6 1997
Pre-market Notification February 6, 1997 Page -3-..............................................................................................................................................................................
VII. 510(k) Summary of Safety and Effectiveness
A. Name and Address
This Summary of Safety and Effectiveness is being submitted by Nobel Biocare USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559., Their telephone Sort, Inc., 177 Calinon extern on 2002, and the contact person will be Betsy Brown, the Director, Regulatory Affairs.
B. Name of the Device
This device consists of fixtures and numerous components to be used in conjunction with the BRÅNEMARK SYSTEM® Zygomaticus Fixture System, including Fixtures, Drills, Hand Instruments, Cover Screws and accessories specific to the Zygomaticus Fixture System.
C. The Predicate Product
The predicate products used in this Premarket Notification are other components marketed by Nobel Biocare including the Fixtures, K925762, Drills, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The predicate products also include a Drill Guide, K951510 which is manufactured by Ace Surgical Supply Co.
D. Description of the Device
The Nobel Biocare BRANEMARK SYSTEM® Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover screws and accessories.
E. Intended Use of the Device
The Nobel Biocare BRANEMARK SYSTEM® Zygomaticus Fixture System is intended to be used as an endosseous implant to be surgically placed in the upper jaw to support prosthetic devices such as artificial teeth and to restore a patient's chewing function.
1
Pre-market Notification February 6, 1997 Page -4-Page -4------------------------------------------
F. Comparison of Technological Characteristics
The technological characteristics between the components of Zygomaticus Fixture System and the corresponding predicate products, comparable components in the BRANEMARK SYSTEM® and the drill guide manufactured by Ace Surgical Supply Co. are identical.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
OCT 16 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Betsy A. Brown Vice President, Regulatory Affairs Nobel Biocare USA, Incorporated 777 Oakmont Lane, Suite 100 ୧୦୧5ର Westmont, Illinois
K970499 Re : Branemark System Zygomaticus Fixture System Trade Name: Regulatory Class: III Product Code: DZE July 18, 1997 Dated: Received: July 23, 1997
Dear Ms. Brown:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Ms. Brown
through 542 of the Act for devices under the Electronic enrough Siz or on Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Alatriot
Timothy A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_
Zygomaticus Fixture System Device Name:
Indications For Use:
The Nobel Biocare Branemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDI
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russer
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)