(70 days)
The Brånemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Branemark System implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
The Brånemark System implant products that are the subject of this 510(k) are threaded, root-form implants fabricated from commercially pure titanium, either machined or modified (TiUnite) surface, and are already commercially available.
The provided text describes a 510(k) summary for various Brånemark System Dental Implant Products, specifically regarding an expanded indication for immediate function. It does not contain information about acceptance criteria or a study proving that a device meets those criteria, as typically seen in submissions for AI/ML-enabled devices.
The submission is for a medical device (dental implants) where the technological characteristics are stated to remain "substantially unchanged" and "no design modifications were made that effect safety and effectiveness." The "Performance Data" section merely states: "Clinical results show that the expanded Indications for Use are as safe and effective as the original Indications for Use." This is a general statement and does not provide specific acceptance criteria or detailed study results.
Therefore, for your request, I must report that the provided text does not contain the requested information regarding acceptance criteria and a study proving a device meets those criteria.
The document is a 510(k) summary focusing on the equivalence of an expanded indication for use for dental implants, not a detailed performance study for a new or modified device with specific acceptance metrics. The questions you've asked are typically relevant for AI/ML-driven devices or those with quantifiable performance metrics that need to be demonstrated against pre-defined acceptance criteria. This document doesn't fall into that category.
{0}------------------------------------------------
Section 1.7
OCT 11 2002
510(k) Summary
| Establishment Information | Nobel Biocare AB15 BohusgatanP.O. Box 5190Goteborg, Sweden S-402 26Phone: 1-800-993-8100, ext 5073Fax: 1-714-998-9348 |
|---|---|
| Contact | Kathleen DragovichRegulatory Affairs Specialist(714) 282-4800, ext. 7834 |
| Proprietary Device Name | Various Brånemark System Dental Implant Products |
| Classification Name | Endosseous Dental Implant (21 CFR 872.3640) |
| Device Classification | Class III |
| Statement | The information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. |
| Device Description | The Brånemark System implant products that are the subject of this 510(k) are threaded, root-form implants fabricated from commercially pure titanium, either machined or modified (TiUnite) surface, and are already commercially available. |
| Intended Use | The intended use of the Brånemark System Implants is for restoring chewing function by serving as anchorage for dental restorations. |
{1}------------------------------------------------
| Indicationsfor Use | The Brånemark System implants are for single-stage or two-stagesurgical procedures and cement or screw retained restorations. TheBrånemark System implants are intended for immediate placementand function on single tooth and/or multiple tooth applicationsrecognizing sufficient bone stability (type I or II bone) andappropriate occlusal loading, to restore chewing function. Multipletooth applications may be splinted with a bar. |
|---|---|
| TechnologicalCharacteristics | The technological characteristics of the Brånemark System implantsremain substantially unchanged. No design modifications were madethat effect safety and effectiveness. |
| PerformanceData | Clinical results show that the expanded Indications for Use are as safeand effective as the original Indications for Use. |
| Conclusion | Based on the 510(k) summaries, 510(k) statements and theinformation provided herein, we conclude that the expandedIndications for Use are substantially equivalent to the currentlymarketed devices under the Federal Food, Drug, and Cosmetic Act. |
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of three human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nobel Biocare AB Ms. Kathleen Dragovich Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
OCT 11 2002
Re: K022562
Trade/Device Name: Various Brânemark System Implants-Immediate Function Indication Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: 76 DZE Dated: July 30, 2002 Received: August 2, 2002
Dear Ms. Dragovich:
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. 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Ms. Dragovich
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely vours.
Patricia Cicciotte
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Section 1.5
Indications for Use Statement
Page 1 of 1
510(k) Number (if known):
Not yet assigned
Device Name:
Various Brånemark System Implants -Immediate Function Indication
Indications for Use:
The Brånemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Branemark System implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109) OR
Over-the-Counter Use Optional Format 1-2-96
Robert S. Betz, DDS for Dr. Susan Rummer
General Hospital.
510(k) Number: K022562
July 2002
§ 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.