(118 days)
Not Found
No
The summary describes a mechanical dental device (a bar for overdenture fixation) and its performance testing, with no mention of software, algorithms, image processing, or AI/ML terms.
No.
The device functions as a structural component for dental overdentures, providing fixation and support, rather than treating or curing a disease or condition.
No
The SFI-Bar® is a device used to provide support for fixation of overdentures to dental implants. Its description and intended use focus on providing a connection and support, not on diagnosing any condition.
No
The device description explicitly states that the SFI-Bar® "consists of an implant adapter (abutment) and a stress-free bar," which are physical components. The performance studies also describe physical testing like torque tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for fixation of overdentures, which is a mechanical function within the body.
- Device Description: The device is described as a connection between dental implants for fixing removable overdentures, consisting of an implant adapter and a stress-free bar. This is a physical, implantable device.
- Lack of IVD Characteristics: The description does not mention any testing of samples (like blood, urine, tissue, etc.) or providing information about a patient's health status or condition based on such testing. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
The device described is a dental prosthetic component, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The SFI-Bar® is intended to be used with the implant manufacturer’s (Table 1) 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 cental 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 and the BioHorizons Implant Systems Tapered Internal Implants / Internal Implants - bone level / Single-stage Implants - tissue level (Implant Platform: Ø 3.5 mm, Ø 4.5 mm, Ø 5.7 mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary. Non-clinical testing consisted of analysis of platforms to identity worst-case test samples. Fatigue testing was not done as the basic design is the same than the predicate device. The evaluation was based on FDA guidance "Class II Special Controls Guidance Document: Root form Endosseous Dental Implants and Endosseous Dental Implant Abutments." Torque tests, application and functional tests have been carried out.
The summary of technological characteristics as well as the torque test, application and functional testing indicate that the device is safe and effective for its intended use and performs as well or better than the predicate devices.
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.
K083876, K111390, K071638, K042429, K073268, K053152, K073282
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
§ 872.3630 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
KBIS26
Image /page/0/Picture/1 description: The image shows a logo with the text "CENDRES+ MÉTAUX". To the left of the text is a stylized symbol that appears to be a combination of the letters 'C' and 'M'. The text is in a bold, sans-serif font, with "CENDRES" on top and "MÉTAUX" below it. The overall design is simple and modern.
May 23, 2013
Image /page/0/Picture/4 description: The image shows a logo with the letters "CM" on the left and the words "CENDRES" and "MÉTAUX" on the right. The letters "CM" are in a bold, sans-serif font and are stacked on top of each other. The word "CENDRES" is in a smaller, sans-serif font and is stacked on top of the word "MÉTAUX". The logo is black and white.
Traditional 510(k) - SFI-Bar® 510(k) Summary
May 23, 2013
510(k) Summary
Applicant's Name and Address
Submitter:
Rue de Boujean 122 2501 Biel/Bienne, Switzerland Phone: +41 58 360 20 00 Fax: +41 58 360 20 10
Cendres + Métaux SA
Tanja Bongni Regulatory Affairs Manager
Date of Submission:
Name of the Device
Contact Person:
Trade Name: Common Name: Classification Name: Regulation Number:
Predicate Device(s):
SFI-Bar Br Abutment, Dental, Endosseous implants Endosseous Dental Implant Abutment 21 CFR 872.3630
Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
May 23, 2013
K083876, K111390, K071638, K042429, K073268, K053152, K073282
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 (abutinent) 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 Plattorn Ø 4.0 mm / the Neoss ProActive Implant Ø 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm and the Straumann cental implants / ITI Dental Implant System@ Standard Ø 4.1 and Ø 4.8 mm / Standard Plus Ø 4.1 mm and 0 4.8 mm / Tapered Effect 0 4.1 and 0 4.8 mm and Regular Neck (RN) Ø 4.8 mm and the BioHorizons Implant Systems Tapered Internal Implants / Internal Implants - bone level / Single-stage Implants - tissue level (Implant Platform: Ø 3.5 mm, Ø 4.5 mm, Ø 5.7 mm).
Page 1 of 6
1
Image /page/1/Picture/0 description: The image shows the logo for Cendres+Metaux. The logo consists of a stylized letter "C" on the left, followed by the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. The text is in a bold, sans-serif font.
May 23, 2013
Image /page/1/Picture/3 description: The image shows a logo with the text "CENDRES+ METAUX". To the left of the text is a stylized letter "M". The text is stacked, with "CENDRES+" on top and "METAUX" on the bottom. The logo is black and white.
Traditional 510(k) - SFI-Bar® 510(k) Summary
May 23, 2013
Intended Use of the Device:
The SFI-Bar® is intended to be used with the implant manufacturer's (Table 1) implant lo provide support for lixation of overdentures.
Table 1 Compatible Commercial Implant Manufacturers:
| Implant Manufacturer | Implant System | Implant Platform Diameter: |
|---|---|---|
| Institut Straumann | ITI Dental Implant System® | Standard 4.1 and 4.8 mm / |
| Standard Plus 4.1 and 4.8 mm / | ||
| Tapered Effect 4.1 and 4.8 mm / | ||
| Regular Neck (RN) 4.8 mm | ||
| Thommen Medical | SPI® Element Platform | 4.0 mm |
| Neoss | Neoss ProActive Implant | 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm |
| BioHorizons | Tapered internal Implant - bone | |
| level | Ø 3.5 mm, Ø 4.5 mm, Ø 5.7 mm | |
| Internal Implants -bone level | ||
| Single-stage Implants - tissue | ||
| level |
Summary Technological Characteristics:
The proposed implant adapters are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and manufacturing procedures are the same as the predicate devices.
The material of the implant adapters conform to ASTM F 136, Whought Titanium-6Aluminium-4Vanadium ELI Alloy for Surgica! Implant applications (UNS R 56401). The parts for the SFI-Bar® System are rnanufactured from wires.
Comparison /Campatibility Substantially Equivatence:
The proposed implant adapters are substantially equivalent to the currently marketed predicate devices. The intended use, basic design. fundamental operating principles and manufacturing procedures are the same as the predicate device.
To ensure compatibility the following process was carried out: The implant adapters are developed and manufactured in close cooperation with the implant companies (see Table 1, column "Implant Company").
There are Quality Agreements between Cendres-Mistaux and the implant companies in place. Those agreements handle arnong other things the Design Control. Change Control, Complaint Handling and Post Market Surveillance,
Table 2 summarizes the substantial equivalence comparison to the predicate device:
Page 2 of 6
2
Image /page/2/Picture/0 description: The image shows a logo with a stylized letter "M" on the left and the words "CENDRES+" and "MÉTAUX" stacked on the right. The letter "M" is bold and has a textured appearance. The text is in a simple, sans-serif font and is also in bold. The overall design is clean and professional.
May 23, 2013 100
Image /page/2/Picture/3 description: The image shows a logo with the letters 'CM' stacked on top of each other on the left side. To the right of the letters, the word 'CENDRES+' is written in all caps on the top line. Below that, the word 'MÉTAUX' is written in all caps on the second line. The logo appears to be for a company that deals with ashes and metals.
.
Traditional 510(k) – SFI-Bar® 510(k) Summary
.
. .
May 23, 2013
Table 2 Substantial Equivalence Comparison to Predicate Devices:
| | SFI-Bar® | Predicate Devices | | Comparison/
Performance
"Predicate Devices" |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| 510(k) No. | Candidate | K083876,
K111390 | K071638,
K042429,
K073268,
K053152,
K073282 | |
| Propriety
Name | SFI-Bar® | SFI-Bar® | "BioHorizons
Tapered Internal
Implant System",
"The Prodigy
System™ Dental
Implants",
"BioHorizons
Single-stage
Implant",
"BioHorizons
Single-stage
Implant Systems",
"BioHorizons
Internal Implant
System" | |
| Model no or
System | 05001022,
05001021,
05001020,
05001019,
05001023,
05001027,
05001026,
05001025,
05001024,
05001028,
05001032,
05001031,
05001030,
05001029,
05001033 | 05000576,
05000577,
05000578,
05000579 | Tapered internal
Implants - bone
level,
$Ø$ 3.8 (y)./ 4.6 (g)
/ 5.8 (h).
Internal Implants -
bone.level,
$Ø$ 3.5 (y) / 4.0 (g)
/ 5.0 (b) / 6.0 (b).
Single- stage
Implants - tissue
level,
$Ø$ 3.5 (y) / 4.0
(y&g) / 5.0 (g&b) /
6.0 (b). | |
| Common
Name: | Abutment for
Endosseous Implant
(Dental) | Abutment for
Endosseous Implant
(Dental) | Endosseous dental
implant | |
| Manufacturer | Cendres + Métaux
SA | Cendres + Métaux SA | BioHorizons
Implant Systems,
Inc. | |
| Product
Codes | NHA | NHA | DZE | Both SFI-Bar®s
are within the
same product |
Page 3 of 6
.
3
Image /page/3/Picture/0 description: The image shows a logo with the text "CENDRES + MÉTAUX". To the left of the text is a stylized letter "M". The text is in a bold, sans-serif font. The logo appears to be for a company or organization related to ashes and metals.
May 23, 2013
.
Image /page/3/Picture/3 description: The image shows a logo with the letters "CM" on the left and the words "CENDRES+" and "MÉTAUX" on the right. The letters "CM" are in a bold, stylized font, and the words "CENDRES+" and "MÉTAUX" are in a smaller, sans-serif font. The logo is black and white. The plus sign is located to the right of the word "CENDRES".
Traditional 510(k) – SFI-Bar® 510(k) Summary
:
1000 - 1000
May 23, 2013
:
| | SFI-Bar® | Predicate Devices | | Comparison/
Performance
"Predicate Devices" |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | Candidate | K083876,
K111390 | K071638,
K042429.
K073268.
K053152.
K073282 | |
| | | | | code. All predicate
devices are within
a dental
application. |
| Regulation
Indicated
use | 872.3630
Intended to be used
with the implant
manufacturer's
implant (Table 1) to
provide support for
fixation of
overdentures. | 872.3630
Intended to be used
with the implant
manufacturer's
implant (Table 1:
SPI® Element
Platform 4.0 mm
implant) to provide
support for fixation of
overdentures. | 872.3640
Dental implant | Equivalent to
SFI-Bar® |
| Manu-
facturing
Process | Machined. Surface
treated (anodized). | Machined. | Machined. Surface
treated (anodized). | All SFI-Bar®
Implant adapter are
machined. The
new devices within
this submission are
also partially
anodized. The
anodization
process has no
influence on the
safety &
effectiveness of the
device. Therefore,
it can be stated
that the
manufacturing
process is
equivalent to the
SFI-Bar®
(predicate devices).
Equivalent to
SFI-Bar®
BioHorizons
implants are also
surface treated
(same color |
Page 4 of 6
.
.
.
.
.
·
4
Image /page/4/Picture/0 description: The image shows a logo with the text "CENDRES+ METAUX". To the left of the text is a stylized letter "C". The text is in a bold, sans-serif font. The plus sign is smaller and slightly raised compared to the other letters.
.
·
.
: ·
Traditional 510(k) Submission USA: SFI-Bar® Format: Based on STED (GHTF/SG1/N011:2008) ·
:
May 23, 2013
·
.....
Image /page/4/Picture/4 description: The image shows a logo with the text "CENDRES+ METAUX". To the left of the text is a stylized symbol that appears to be a combination of the letters 'C' and 'M'. The text is stacked, with "CENDRES+" on top and "METAUX" below it. The logo is in black and white.
Traditional 510(k) - SFI-Bar® 510(k) Summary
: · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
·
May 23, 2013
.
| | SFI-Bar® | Predicate Devices | | Comparison/
Performance
"Predicate Devices" |
|-----------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------|
| 510(k) No. | Candidate | K083876,
K1.11390 | K071638,
K042429,
K073268,
K053152,
K073282 | |
| Operating
Principle /
Basic
Design | Impression taking:
Optional,
preassembled (plug-
in connection). | Impression taking:
Optional,
preassembled (plug-in
connection). | Not relevant | ≒ Equivalent to
SFI-Bar® |
| | Abutment implant
connection: Screw
fixation. | Abutment implant
connection: Screw
fixation. | | |
| | Connecting principle
to overdenture:
Retentive system. | Connecting principle
to overdenture:
Retentive system. | | |
| | Cleaning procedures
for patient: Common
procedure for oral
hygiene. | Cleaning procedures
for patient: Common
procedure for oral
hygiene. | | |
| | Patient handling:
Common cleaning
and insertion of
prosthesis. | Patient handling:
Common cleaning and
insertion of denture. | | |
| Materials
incorporated
into key
functional
elements | Titanium | Titanium | Not relevant | ≒ Equivalent to
SFI-Bar® |
| Shelf Life | 95% after 10 years | 95% after 10 years | Not known by
Cendres + Métaux
SA | ≒ Equivalent to
SFI-Bar® |
| Packaging
and
sterilization | Dentalblister, non-
sterile. | Dentalblister, non-
sterile.
Tubular bag, non-
sterile | Not relevant | ≒ Equivalent to
SFI-Bar® |
Pertormance Data:
.
·
Torque tests, application lesting and lunctional lesting have been conducted to evaluate the performance characteristics of the additional SFI-Rarib. The test methods used were the same as in the predicate device. Testing has shown that the SFI-BarQi is equivalent in performance characteristics to the predicate SFI-Bair®. The acceptance culeria were met.
. Page 5 of 6
・
:
CONFIDENTIAL
. . . .
、
·
:
5
Image /page/5/Picture/0 description: The image contains a logo with the text "CENDRES+ METAUX". To the left of the text is a stylized letter "C" that is bolded. The text is stacked, with "CENDRES+" on top and "METAUX" on the bottom. The text and the "C" are all in black.
1
.
·
May 23, 2013
Image /page/5/Picture/3 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 symbol that appears to be a combination of the letters 'C' and 'M'. The text and symbol are in black, and the background is white. The logo is simple and clean, with a focus on the text.
Traditional 510{k} - SFI-Bar® 510(k) Summary
May 23, 2013
Summary of Testing to Oernonstrate Safety and Effectiveness / Conclusion:
Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary. Non-clinical testing consisted of analysis of platforms to identity worst-case test samples. Faligue lesting was not done as the basic cesign is the same than the predicate device. The evaluation was based on FDA guidance "Class II Soccial Controls Guidance Document: Root form Endosseous Dental Implants and Endosseous Dental Implant Abutments." Torque tests, application and functional tests have been carried out.
The summary of technological characteristics as well as the torque test, application and functional testing indicate that the cevice is safe and . effective for its intended use and performis as well or better than the predicate devices.
Page 6 of 6
6
Image /page/6/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
September 23, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cendres & Metaux SA Ms. Tanja Bongni Regulatory Affairs Manager Rue De Boujean 122 2501 Biel/Bienne, Switzerland
Re: K131526
Trade/Device Name: SFI-Bar® Regulation Number: 21 CFR 872.3630 Regulation Name: Endosscous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 11, 2013 Received: September 13, 2013
Dear Ms. Bongni:
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 cnactment 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 cither 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.
7
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicallDevices/Safets/Reportal/roblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Richard C. Chapman 2013.09.23 13:19:52 -04'00'
for
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Image /page/8/Picture/0 description: The image shows a logo with the text "CENDRES+ METAUX". To the left of the text is a stylized letter "C" that is connected to the letter "M". The text is stacked, with "CENDRES+" on top and "METAUX" on the bottom.
May 23, 2013
Indications for Use
KISIS26 5 10(k) Number (if known):
Device Name:
SFI-Bark
Indications for Use:
The SFI-Bans is intended to be used with the implant translations in the called in to provide support ler lixation of overdentures.
Only the imp ant systems listed in Table I may be used will SFI-Mar-y.
The compatible implant systems are specified in Table . below
| Implant Manufacturer | Implant System | Implant Platform Diameter |
|---|---|---|
| Institut Straumann | ITI Dental Implant System | Standard 4.1 and 4.8 mm / |
| Standard Plus 4.1 and 4.8 mm / | ||
| Tapered Effect 4.1 and 4.8 mm / | ||
| Regular Neck (RN) 4.8 mm | ||
| Thommen Medica | SPI Element Platform | 4.0 mm |
| Neoss | Neoss ProActive Implant | 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm |
| BioHorizons | Tapered Internal Implant - bone level | ⌀ 3.5 mm, ⌀ 4.5 mm, ⌀ 5.7 mm |
| Internal Implants - bone level | ||
| Single-stage Implants - tissue level |
Table I Compatible Implani Systems
AND / OR Prescription Jsc × (Pari 21 CFR 801 Subpart D)
Over-The-Counter Jsc (2) CFR 801 Subpart C)
(PLEASE DO NOT WRITE RELOW THIS : INE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORH. Office of Device Evaluation (OOE)
Andrew I. Steen -S 2013.09.23 08:00:13 -04'00'
:Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Fage : ci l
K131524 510(k) Number: