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.

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.

AI/ML Overview

This looks like a 510(k) pre-market submission for a dental device, specifically an orthodontic implant system. It describes the device, its intended use, and identifies predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving device performance against such criteria.

The provided text is a summary of safety and effectiveness from a 510(k) submission, along with the FDA's clearance letter. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove effectiveness or meet specific performance criteria through new studies. Often, for devices like this, substantial equivalence is established through comparison of materials, design, and intended use to existing devices that have already demonstrated safety and effectiveness in the market.

Therefore, I cannot fulfill your request for the following sections because the information is not present in the provided text:

A table of acceptance criteria and the reported device performance: This document does not establish specific performance criteria or report performance data.
Sample size used for the test set and the data provenance: No clinical or performance studies are described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable; no such study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/algorithm device.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of what's provided:

Device Name: Nobel Biocare Onplant Orthodontic System
Intended Use: An implant intended to be surgically placed subperiostally in the palatal region of the mouth for use as an anchor for orthodontic procedures in patients who have completed skeletal growth and maturity.
Predicate Products: Various Nobel Biocare components (Cylinders, Abutments, Cover Screws, Abutment Replica, Hand Instruments), Linkow Blade Implant (Steri-Oss), Orthodontic Wire (Dentaurum, Star Dental).
Regulatory Status: Cleared by FDA as substantially equivalent to predicate devices (K980460).

To find the kind of information you are looking for (acceptance criteria and detailed study results), you would typically need to consult a different type of document, such as a pre-market approval (PMA) application for a Class III device (which this device is classified as, but cleared via 510(k) with substantial equivalence to older devices), or specific clinical study reports if they were conducted and made public. In a 510(k) for a device like this, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical performance data if the technological characteristics are similar.

Summary

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K980460

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

E. Intended Use of the Device

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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

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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

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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 ________
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(Optional Format 1-2-96)

Regulation Number and Section

§ 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.