(92 days)
Not Found
No
The document describes a physical implant system and its components, with no mention of software, algorithms, or any terms related to AI or ML.
No
The device is used as an anchor for orthodontic procedures, not to treat a disease or condition itself.
No
The provided text explicitly states the device is an implant "intended to be surgically placed subperiosteal in the palatal region of the mouth for use as an anchor for orthodontic procedures." Its purpose is to provide a physical anchor, not to diagnose a condition or disease.
No
The device description explicitly states it is an "implant with components made of titanium" and lists various hardware components like implants, cylinders, abutments, etc. This clearly indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implant intended for surgical placement in the mouth to serve as an anchor for orthodontic procedures. This is a therapeutic and structural function within the body.
- Device Description: The description details the components of a surgical implant system made of titanium, designed for physical placement and support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a physical implant used for mechanical support in orthodontic treatment.
N/A
Intended Use / Indications for Use
The Nobel Biocare Onplant Orthodontic System is an implant intended to be surgically placed subperiosteal in the palatal region of the mouth for use as an anchor for orthodontic procedures in patients who have completed skeletal growth and maturity.
Product codes
DZE
Device Description
The Nobel Biocare Onplant Orthodontic System is an implant with components made of titanium intended for subperiosteal placement in the palatal region of the mouth to provide an anchor for orthodontic procedures. The system includes Implants, Cylinders, Abutments, Orthodontic Wire, 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
palatal region of the mouth
Indicated Patient Age Range
patients who have completed skeletal growth and maturity.
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)
K925776, K925776, K925771, K944964, K925774, K925772, K935142
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
MAY 5 1998
Pre-market Notification Page -5------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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. Our telephone number is: (630) 654-9100, extension 2002, and the contact person will be Betsy Brown, the Vice President, Regulatory Affairs.
B. Name of the Device
This device consists of implants and numerous components to be used in conjunction with the Onplant Orthodontic System™, including implants, cylinders, abutments, orthodontic wire, cover screws, hand instruments, and accessories used in conjunction with the Onplant Orthodontic System.
C. The Predicate Product
The predicate products used in this Pre-market Notification are other components marketed by Nobel Biocare including the Cylinders, (K925776), Abutments and Abutment Screws (K925776), Cover Screws, (K925771),. Abutment Replica (K944964), Hand Instruments, (K925774 and K925772) as well as other orthodontic anchor devices such as the Linkow Blade Implant, which is marketed by Steri-Oss, and Orthodontic Wire (K935142) marketed by Dentaurum, and pre-amendment orthodontic wire marketed by Star Dental.
D. Description of the Device
The Nobel Biocare Onplant Orthodontic System is an implant with components made of titanium intended for subperiosteal placement in the palatal region of the mouth to provide an anchor for orthodontic procedures. The system includes Implants, Cylinders, Abutments, Orthodontic Wire, Hand Instruments, Cover Screws and accessories.
E. Intended Use of the Device
The Nobel Biocare Onplant Orthodontic System is an implant intended to be surgically placed subperiosteal in the palatal region of the mouth for use as an anchor for orthodontic procedures in patients who have completed skeletal growth and maturity.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1998 MAY
Ms. Betsy Brown ·Vice President, Regulatory Affairs Nobel Biocare USA, Incorporated 777 Oakmont Lane, Suite 100 Westmont, Illinois 60559
Re : K980460 Trade Name: Onplant Orthodontic System™ Regulatory Class: III Product Code: DZE Dated: February 2, 1998 Received: February 2, 1998
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 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.
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 Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
2
Page 2 - Ms. Brown
the Act for devices under the Electronic Product Radiation 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 debting of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed processoremits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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
premarket notification" (21 CFR 807.97). 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Onplant™ Orthodontic System Device Name: ____
Indications For Use:
The Nobel Biocare Onplant Orthodontic System is an implant intended to be surgically placed The Nobel Blocare Unplant Orthodolite System is an anchor for orthodonic procedures in patients subperies and mater al growth and maturity.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off)Susan RusovejDivision of Dental, Infection Control, and General Hospital Devices510(k) NumberK980460 | (Division Sign-Off) | Susan Rusovej | Division of Dental, Infection Control, and General Hospital Devices | 510(k) Number | K980460 | ||||
|---|---|---|---|---|---|---|---|---|---|
| (Division Sign-Off) | Susan Rusovej | ||||||||
| Division of Dental, Infection Control, and General Hospital Devices | |||||||||
| 510(k) Number | K980460 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use ________ | |
|---|---|---|---|
| --------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---- | ------------------------------- |
(Optional Format 1-2-96)