(117 days)
Not Found
No
The document describes a mechanical dental device and does not mention any AI or ML components or functionalities.
No
The device is a component for dental implants designed to provide support and fixation for overdentures, which is a structural rather than a therapeutic function.
No
The device description clearly states its purpose is to provide support for the fixation of overdentures and connect dental implant systems, which are mechanical and structural functions, not diagnostic ones.
No
The device description explicitly states it consists of physical components: an implant adapter (abutment) and a stress-free bar. The performance studies also mention validation of sterilization for metallic components, indicating hardware.
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 SFI-Bar® is for providing support for fixation of overdentures, used with dental implants. This is a mechanical function within the oral cavity.
- Device Description: The description details a physical device (implant adapter and stress-free bar) that connects to dental implants for fixing removable overdentures. This is a structural and mechanical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory setting or for point-of-care testing of biological samples.
The SFI-Bar® is a dental prosthetic device used for mechanical support and fixation within the oral cavity.
N/A
Intended Use / Indications for Use
The SFI-Bar® is intended to be used with the implant manufacturer's (TABLE A) implant to provide support for fixation of overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.
The implant adapter (abutment) fit the Thommen SPI® Element Platform Ø 4.0 mm / the Neoss ProActive Implant Ø 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm and the Straumann dental implants / ITI Dental Implant System® Standard Ø 4.1 and Ø 4.8 mm / Standard Plus Ø 4.1 mm and Ø 4.8 mm / Tapered Effect Ø 4.1 and Ø 4.8 mm and Regular Neck (RN) Ø 4.8 mm.
The implants (min. 2) in the mandible can be fitted with the SFI-Bar® immediately after implantation, provided the following criteria are met:
- Implant manufacturers permit immediate loading in their system.
- No necessity for simultaneous guided bone regeneration; implants surrounded on all sides by local bone.
- Implant insertion torque min. 35 Ncm.
- All parts are sterilized or disinfected.
- Pull-of strength during osseointegration
§ 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.)
0
Image /page/0/Picture/0 description: The image shows a logo with the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. To the left of the text is a stylized letter "C" that is thicker than the text. The text and the letter "C" are in black and the background is white.
2011 12
K1113910
Attachment: 510(k) Summary
Applicant's Name and Address
Submitter:
CENDRES+METAUX SA Rue de Boujean 122 2501 Biel/Bienne, Switzerland Phone: +41 58 360 20 00 +41 58 360 20 10 Fax:
Contact Person:
Tanja Bongni Consultant Regulatory Affairs
Date of Submission:
May 09, 2011
Name of the Device
Trade Name: Common Name: Classification Name: Regulation Number:
SFI-Bar® Abutment. Dental. Endosseous implants Endosseous Dental Implant Abutment 21 CFR 872.3630
Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
Predicate Device(s):
Description of the Device
Device Description:
The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.
The implant adapter (abutment) fit the Thommen SPI® Element Platform Ø 4.0 mm / the Neoss ProActive Implant Ø 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm and the Straumann dental implants / ITI Dental Implant System® Standard Ø 4.1 and Ø 4.8 mm / Standard Plus Ø 4.1 mm and Ø 4.8 mm / Tapered Effect Ø 4.1 and Ø 4.8 mm and Regular Neck (RN) Ø 4.8 mm.
The implants (min. 2) in the mandible can be fitted with the SFI-Bar® immediately after implantation, provided the following criteria are met:
- Implant manufacturers permit immediate loading in their -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------system.
- No necessity for simultaneous guided bone regeneration; -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------implants surrounded on all sides by local bone.
- Implant insertion torque min. 35 Ncm.
- All parts are sterilized or disinfected.
- Pull-of strength during osseointegration