(169 days)
Not Found
No
The summary describes a mechanical dental implant abutment system and does not mention any computational or data-driven components that would suggest the use of AI or ML.
No
The device is described as a prosthetic framework to support and/or retain removable dental prostheses to restore chewing function, which is a supportive and restorative function, not a therapeutic one that treats a disease or condition.
No
The device is described as a prosthetic framework for dental implants to support and/or retain removable dental prostheses, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a physical implant abutment made of materials that connect to dental implants and support removable prostheses. It describes physical components and their compatibility with different implant systems.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used with dental implants as a prosthetic framework to support and/or retain removable dental prostheses to restore chewing function. This is a mechanical and structural function within the body.
- Device Description: The description details a physical connection between dental implants and removable overdentures. It describes components like abutments and bars, and their compatibility with different implant systems.
- 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. The device itself is a physical implant component.
Therefore, the SFI-Bar® Implant Abutments are a medical device, specifically a dental prosthetic component, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
The SFI-Bar® Implant Abutments are compatible with the following implant systems:
| Implant Brand | Model |
|---|---|
| Straumann | Straumann Bone Level RC, Blue Sky Bio Square Taper RC |
| Straumann | Straumann Bone Level NC, Blue Sky Bio Square Taper NC |
| Ankylos | Ankylos |
| Nobel Biocare | Nobel Replace WP, Nobel Replace Select WP, NobelSpeedy Replace WP, Implant Direct 5.0 RePlant, BlueSky Bio 5.0 Trilobe |
| Nobel Biocare | Nobel Conical Connection RP |
| Nobel Biocare | Nobel Conical Connection NP, Blue Sky Bio Max |
| Astra Dental | Astra 4.5 / 5.0, Blue Sky Bio Conus 12 4.5 / 5.0 |
| Astra Dental | Astra 3.5 / 4.0, Blue Sky Bio Conus 12 3.5 / 4.0 |
| Zimmer Dental | Zimmer TSV 5.7mm, Implant Direct Legacy 5.7, BioHorizon 5.7 |
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment.
The implant abutments fit Straumann Bone Level RP, Straumann Bone Level NP, Ankylos, Nobel 5mm Trilobe, Nobel Conical RP, Nobel Conical NP, Astra 4.5/5.0, Astra 3.5/4.0, Zimmer TSV 5.7mm.
There are nine (9) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [BD], [BE], [AE], [AN], [AY], [AY], [AJ], [AK], [BF]. Table 1 indicates which implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant.
The devices are supplied non-sterile, therefore there is no shelf life.
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)
Application and functional testing have been conducted to evaluate the performance characteristics of the SFI Bar® Implant Abutments. The test methods used were the same as in predicate devices. Testing has shown that the SFI-Bar® Implant Abutments included in this application are equivalent in performance characteristics to the predicate SFI Bar®. The acceptance criteria were met.
Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary. The non-clinical testing consisted of tolerance analysis of platforms ... Fatigue testing .was-not-done as the basic design is the same as the predicate devices. 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 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.
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
K13 27164
Fr: 2 5 2014
Sterngold Dental, LLC Abbreviated 510(k) Premarket Notification
September 6, 2013 SFI Bar® Implant Abutments for 9 Implant Platforms
510(k) Summary
| Sponsor: | Sterngold Dental, LLC
23 Frank Mossberg Drive
Attleboro, MA 02703 |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Contact: | Maria Rao, QA/RA Director
Ph: 508-226-5660 ext 1206 |
| Trade Name: | SFI Bar® Implant Abutments |
| Common Name: | Implant Abutments |
| Classification Name: | Endosseous Dental Implant Abutment |
| Classification: | According to Section 513 of the Federal Food, Drug, and
Cosmetic Act, the device classification is Class II |
| Product Code: | NHA (21CFR 872.3630) |
Legally Marketed Device to which Equivalence is claimed (Predicate Devices): Predicate Device(s): K130183, K102382.
| K130183 | SFI Bar® Implant Abutments for 7 Platforms |
|---|---|
| K102382 | SFI Bar® Implant Adapter Straumann, SFI Bar® Implant Adapter Neo |
Description of Device:
Device Description: The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment.
The implant abutments fit Straumann Bone Level RP, Straumann Bone Level NP, Ankylos, Nobel 5mm Trilobe, Nobel Conical RP, Nobel Conical NP, Astra 4.5/5.0, Astra 3.5/4.0, Zimmer TSV 5.7mm.
See table 1 for platform compatibility.
There are nine (9) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [BD], [BE], [AE], [AN], [AY], [AY], [AJ], [AK], [BF]. Table 1 indicates which implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant.
The devices are supplied non-sterile, therefore there is no shelf life.
1
Abutment Insertion
Choose the abutment with the proper cuff height that fits on the existing implant. Abutment platforms should be 1 to 2 mm above the gingival level and approximately parallel to the occlusal plane. However, to allow the subsequent placement of the sections of SFI-Bar on top of these abutments so that the bars are approximately parallel to the occlusal plane, it may be necessary to choose some abutments with different heights. Abutments are screwed into each implant.
Intended Use of the Device:
The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
Model Implant Brand Straumann Bone Level RC, Blue Sky Bio Square Taper RC Straumann Straumann Bone Level NC, Blue Sky Bio Square Taper NC Straumann Ankylos Ankvlos Nobel Replace WP, Nobel Replace Select WP, NobelSpeedy Replace WP, Nobel Biocare Implant Direct 5.0 RePlant, BlueSky Bio 5.0 Trilobe Nobel Biocare Nobel Conical Connection RP Nobel Conical Connection NP, Blue Sky Bio Max Nobel Biocare Astra 4.5 / 5.0, Blue Skv Bio Conus 12 4.5 / 5.0 Astra Dental Astra 3.5 / 4.0. Blue Sky Bio Conus 12 3.5 / 4.0 Astra Dental Zimmer TSV 5.7mm, Implant Direct Legacy 5.7, BioHorizon 5.7 Zimmer Dental
The SFI-Bar® Implant Abutments are compatible with the following implant systems:
Summary Technological Characteristics:
The proposed implant abutments 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 abutments conform to ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy.
Comparison/Compatibility
Substantial Equivalence:
The proposed implant abutments 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.
To ensure compatibility the following process was carried out: The implant abutments were designed and developed, and manufactured according to manufacturer's
specifications and controlled procedures. A validation protocol was done in accordance with Design Control requirements per FDA CFR820.30.
Table 2 summarizes the substantial equivalence comparison to the predicate devices.
2
Performance Data:
Application and functional testing have been conducted to evaluate the performance characteristics of the SFI Bar® Implant Abutments. The test methods used were the same as in predicate devices. Testing has shown that the SFI-Bar® Implant Abutments included in this application are equivalent in performance characteristics to the predicate SFI Bar®. The acceptance criteria were met.
Summary of Testing to Demonstrate Safety and Effectiveness / Conclusion:
Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary. The non-clinical testing consisted of tolerance analysis of platforms -to-identify-worst-case-test-samples ... Fatigue testing .was-not-done as the basic design is the same as the predicate devices. 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 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.
13.4
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
February 25, 2014
Sterngold Dental LLC Ms. Maria Rao Quality Assurance Director 23 Frank Mossberg Drive Attleboro, MA 02703
Re: K132814
Trade/Device Name: SFI Bar Implant Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 21, 2014 Received: January 22, 2014
Dear Ms. Rao:
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.
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
4
Page 2 - Ms. Cheng
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 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.fda.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/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,
Image /page/4/Picture/8 description: The image shows the name "Kwame O. Ulmer" in bold, black font. Below the name, there is a faded, patterned design that is difficult to discern. The letter "S" is located to the left of the design, also in bold, black font.
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Sterngold Dental, LLC Abbreviated 510(k) Premarket Notification
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.. . . . . .
September 6, 2013 SFI Bar® Implant Abutments for 9 Implant Platforms
INDICATIONS FOR USE STATEMENT
SECTION 2
:
.. . . . . . . . . .
and the country of the country of the country of the country
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510(k) Number (if known): K132814
Device Name: SFI Bar® Abutments for 9 Implant Platforms
Indications for Use:
The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
The SFI-Bar® Implant Abutments are compatible with the following implant systems:
| Implant Brand | Model |
|---|---|
| Straumann | Straumann Bone Level RC, Blue Sky Bio Square Taper RC |
| Straumann | Straumann Bone Level NC, Blue Sky Bio Square Taper NC |
| Ankylos | Ankylos |
| Nobel Biocare | Nobel Replace WP, Nobel Replace Select WP, NobelSpeedy Replace WP, |
| Implant Direct 5.0 RePlant, BlueSky Bio 5.0 Trilobe | |
| Nobel Biocare | Nobel Conical Connection RP |
| Nobel Biocare | Nobel Conical Connection NP, Blue Sky Bio Max |
| Astra Dental | Astra 4.5 / 5.0, Blue Sky Bio Conus 12 4.5 / 5.0 |
| Astra Dental | Astra 3.5 / 4.0, Blue Sky Bio Conus 12 3.5 / 4.0 |
| Zimmer Dental | Zimmer TSV 5.7mm, Implant Direct Legacy 5.7, BioHorizon 5.7 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Mary S. Runner - S 2014.02.24 0.28.46 05.00 Over-the -Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart D) (Part 21 CFR 801 Subparts D) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. . ...
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