(424 days)
Not Found
No
The summary describes a dental bar for overdenture fixation and makes no mention of AI or ML technology.
No.
The device provides support for fixation of overdentures, which is a structural and mechanical function rather than a therapeutic one (i.e., treating or preventing a disease).
No
The device is described as providing support for fixation of overdentures, which is a structural and prosthetic function, not a diagnostic one. It is used to connect implants in the jaw.
No
The device description is not available, but the intended use clearly describes a physical "bar" intended to be used with a physical implant for fixation of overdentures. This indicates a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SFI-Bar is used to "provide support for fixation of overdentures" in the lower and upper jaw. This is a mechanical function within the body.
- Device Description: While the description is "Not Found" in the provided text, the intended use and anatomical site strongly suggest a physical implant component.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), detecting diseases, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SFI-Bar is a device implanted in vivo (within the body) for structural support.
N/A
Intended Use / Indications for Use
The SFI-Bar® is intended to be used with the SPI Element Platform 4.0 mm implant (K070007) to provide support for fixation of overdentures.
The SFI Bar consists of the following variants:
SFI-Bar® 2 Implant:
Lower jaw: Connecting 2 or 2x2 implants in the intraforaminal region
Upper jaw: Connecting 2x2 implants in the anterior/premolar region
SFI-Bar® 4 Implant:
Lower jaw: Connecting 4 implants in the intraforaminal region
Upper jaw: Connecting 4 implants in the anterior/premolar region
Product codes
NHA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower jaw, Upper jaw, intraforaminal region, anterior/premolar region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Peter W. Fleetwood Cendres & Metaux SA Rue De Boujean 122 Biel/Bienne Switzerland 2501
FEB 2 6 2010
Re: K083876
Trade/Device Name: SFI-Bar® Regulation Number: 21 CFR 872,3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 9, 2010 Received: February 17, 2010
Dear Mr. Fleetwood:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutEDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Th for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo with the letter 'C' on the left and the words 'CENDRES+' and 'MÉTAUX' on the right. The letter 'C' is stylized and bold. The word 'CENDRES+' is above the word 'MÉTAUX'. The text is in a simple, sans-serif font.
Traditional 510(k) (K083876) Applicant's Response to Additional Information Request
B. Indications for Use Statement
510(k) Number (if known): K083876
Device Name: SFI-Bar®
Indications For Use:
The SFI-Bar® is intended to be used with the SPI Element Platform 4.0 mm implant (K070007) to provide support for fixation of overdentures.
The SFI Bar consists of the following variants:
| SFI-Bar® 2 Implant: | Lower jaw: |
|---|---|
| Connecting 2 or 2x2 implants in the intraforaminal region | |
| Upper jaw: | |
| Connecting 2x2 implants in the anterior/premolar region |
SFI-Bar® 4 Implant: Lower jaw:
Connecting 4 implants in the intraforaminal region Upper jaw: Connecting 4 implants in the anterior/premolar region
Prescription Use
AND/OR . Over-The-Counter Use
No
X yes
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBetz DDS for Dr. K.E. Mulry
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083876