(27 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of such technologies.
No
The device is described as an implant used for permanent anchorage for prosthetic devices to restore chewing function, not for therapeutic purposes.
No
The device is described as an implant for surgical placement into the jaw bone to restore chewing function, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant fabricated from titanium, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical placement into bone for prosthetic anchorage and restoring chewing function. This is a surgical implant, not a test performed on samples taken from the body.
- Device Description: The device is described as threaded, root-form implants made of titanium. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The BRÅNEMARK INTEGRATION products are intended for surgical placement into the bone of upper/lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing.
The Brånemark Integration implants and accessories are subjected for one or two-stage surgical procedures, and either for cemented or screw retained prosthetic restorations. The implants are intended for immediate placement on a single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing and speech function. Multiple tooth applications may be connected with a bar.
The Brånemark Integration AB, implants and accessories is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.
Product codes
DZE
Device Description
The Brånemark Integration implant products that are subject of this 510(k) are threaded, root-form implants fabricated from commercially pure titanium, and machined and are commercially available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of upper/lower jaw arches
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)
Clinical result show that expanded Indications for Use are as safe and effective as the original Indications for Use.
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.
Not Found
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
K040643
APR - 7 2004
SECTION I.
510(K) SUMMARY
| Establishment
Information | Brånemark Integration AB
1 Lilla Bommen
Göteborg, Sweden, SE-411 04
Phone: +46 31 760 10 60
Fax: +46 31 15 52 60 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Jan-Olof Djerf
Quality Management & Regulatory Affairs, Manager
Phone: +46 31 760 10 63 |
| Proprietary
Device Name | Brånemark Integration Dental Implant and Accessories |
| 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 Integration implant products that are subject of this
510(k) are threaded, root-form implants fabricated from
commercially pure titanium, and machined and are commercially
available. |
| Intended
Use | The BRÅNEMARK INTEGRATION products are intended for
surgical placement into the bone of upper/lower jaw arches as a
permanent anchorage for prosthetic devices and to restore chewing |
1
| Indications
for use | The Brånemark Integration implants and accessories are subjected for
one or two-stage surgical procedures, and either for cemented or
screw retained prosthetic restorations. The implants are intended for
immediate placement on a single tooth and/or multiple tooth
applications recognizing sufficient bone stability (type I or II bone)
and appropriate occlusal loading, to restore chewing and speech
function. Multiple tooth applications may be connected with a bar. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The technological characteristics of the Brånemark Integration
implants and accessories remain substantially unchanged from the
original Brånemark System® design . No design modifications were
made that effect safety and effectiveness. |
| Performance
Data | Clinical result show that expanded Indications for Use are as safe and
effective as the original Indications for Use. |
| Conclusion | Based on the 510(k) summaries, 510(k) statements and the
information provided in this submission, we conclude that the
products are substantially equivalent to currently marketed devices
under the Federal Food, Drug and Cosmetic Act. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is black, and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 2004
Ms. Jan-Olof Djerf Quality management & Regulatory Affairs, Manager Branemark Integration A.B. Lilla Bommen 1 SE-411 04 Gothenburg SWEDEN
Re: K040643
Trade/Device Name: Brånemark Integration Endosseous Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: March 5, 2004 Received: March 11, 2004
Dear Ms. Djerf:
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 ahove) 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. Djerf
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), please contact the Office of Compliance at (301) 594-5613. Also, please note the regulation entitled, "Misoranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
feHWunteshen
Image /page/3/Picture/6 description: The image contains a handwritten word, "for", in cursive script. The letters are connected, with the "f" having a prominent loop extending above the baseline and a curved tail extending below. The "o" is a closed oval shape, and the "r" has a short, curved stroke extending from the top of the letter.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 2 INDICATIONS FOR USE
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Device Name: Brånemark Integration Endosseous Dental Implant
Indications for Use:
The Brånemark Integration AB, implants and accessories is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Usc
(Pcr 21 CFR 801.109)
ાર
Over the Counter Use
Robert S. Betz, DDS for Dr. S. Runner
510(k) Number: K040643