(163 days)
No
The summary describes a physical dental abutment and its materials, with no mention of software, algorithms, or AI/ML capabilities.
No
The device, an abutment, supports prosthetic reconstructions and does not directly treat or cure an illness or injury.
No
The device is described as an abutment intended to provide support for prosthetic reconstructions, and its function is to restore dental implants. It does not perform any diagnostic function.
No
The device description clearly details physical components made of Ceramicor® alloy, Ti-6AI-7Nb, and Polyoxymethylene (POM), indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the abutments are "intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures." This describes a device used in vivo (within the body) for structural support, not for testing samples in vitro (outside the body).
- Device Description: The description details the physical components of the abutment and how it connects to a dental implant. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not contain any of the typical indicators of an IVD, such as:
- Mention of analyzing blood, urine, tissue, or other biological samples.
- Mention of reagents, assays, or diagnostic tests.
- Mention of providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
Therefore, the Straumann abutments described are medical devices used for dental restoration, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Straumann prosthetic line consist of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.
The Straumann BLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by mean of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). The screw channel is protected during the lab procedure with a modeling aid made of Polyoxymethylene (POM) which is friction fit to the Ceramicor® alloy base. The modeling aid is a burn-out sleeve for casting and the combination of base and modeling aid is designed to be used together with Straumann BLX Implants having the TorcFit™, conical connection.
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)
Biocompatibility Testing: The subject devices have been assessed for biological safety according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for the subject device. The subject device is made out of the same material as the primary predicate device, therefore, biocompatibility is represented by the primary predicate. The subject devices are equivalent with regard to nature of body contact, contact duration, material formulation and sterilization methods compared to the primary and reference predicate devices and therefore, no new testing has been performed.
Sterilization: The proposed BLX Gold Abutments are single patient devices and are provided non-sterile. The recommended end user sterilization via Moist Heat Steam sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
Bench Testing: Dynamic fatigue, static strength, and loosening torque tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Testing was performed on worst-case construct. The worst-case construct is based on several device features such as diameter, wall thickness and orientation and intends to represent the performance behavior of all the devices within this submission. The worst-case construct was tested and results demonstrated equivalence to 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.
K072497, K071888, K190662, K173961
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
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August 19, 2020
Straumann USA, LLC (On behalf of Institut Straumann AG) Chanrasmey White Regulatory Affairs Specialist 60 Minuteman Road Andover, Massachusetts 01810
Re: K200597
Trade/Device Name: Straumann® BLX Gold Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 16, 2020 Received: July 20, 2020
Dear Chanrasmey White:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200597
Device Name Straumann® BLX Gold Abutments
Indications for Use (Describe)
Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Straumann® BLX Gold Abutments
510(k) Summary
510(k) Summary 5
Submitter 5.1
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
| Phone Number: | 978-747-2614 |
|---|---|
| --------------- | -------------- |
Fax Number: 978-747-0023
Chanrasmey White Contact Person:
Date of Submission: August 18, 2020
5.2 Device
| Trade Name: | Straumann® BLX Gold Abutments |
|---|---|
| Common Name: | Endosseous Dental Implant Abutments |
| Classification Name: | Endosseous Dental Implant Abutments |
| Regulatory Class: | II (21 CFR 872.3630) |
| Product Code: | NHA (21 CFR 872.3630) |
5.3 Predicate Device
Primary Predicate:
K070549 - RC Gold Abutments
Reference Predicate:
K072497 - NC Gold Abutment, crowns
K071888 – Gold Abutment for Bridge
K190662 – MRI Compatibility for Existing Straumann Dental Implant System
K173961 - BLX Implant System
4
Straumann® BLX Gold Abutments
510(k) Summary
5.4 Device Description
The Straumann prosthetic line consist of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.
The Straumann BLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by mean of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). The screw channel is protected during the lab procedure with a modeling aid made of Polyoxymethylene (POM) which is friction fit to the Ceramicor® alloy base. The modeling aid is a burn-out sleeve for casting and the combination of base and modeling aid is designed to be used together with Straumann BLX Implants having the TorcFit™, conical connection.
5.5 Indications for Use
Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.
Technoloqical Characteristics 5.6
The subject device is equivalent to the primary predicate cleared per K070549 and reference devices cleared per K072497 and K071888 with the exception of the implant to abutment connection which is TorcFit™ to fit the implants of the BLX Implant System cleared per K173961. The reference device K190662 is included to address MRI compatibility only.
The technological characteristics of the proposed BLX Gold Abutments are compared to the primary predicate in Table 1.
5
Straumann® BLX Gold Abutments
510(k) Summary
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K200597 | K070549 | K072497 | K071888 |
| Indications for
Use | Straumann abutments are
intended to be placed into
Straumann dental implants to
provide support for prosthetic
reconstructions such as crowns,
bridges, and overdentures. | Abutments are intended to be
placed into dental implants to
provide support for prosthetic
reconstructions such as
crowns, bridges and
overdentures. | Abutments are intended to be
placed into dental implants to
provide support for prosthetic
reconstructions such as
crowns, bridges and
overdentures. | Abutments are intended to be
placed into dental implants to
provide support for prosthetic
reconstructions such as
crowns, bridges and
overdentures. |
| Material | Ceramicor® | Ceramicor® | Ceramicor® | Ceramicor® |
| Abutment
Shape in
Coronal
Portion | Axial screw access hole for
placement of abutment into
implant | Axial screw access hole for
placement of abutment into
implant | Axial screw access hole for
placement of abutment into
implant | Axial screw access hole for
placement of abutment into
implant |
| Design of
Basal Portion
of Abutment | TorcFit™ Connection for BLX
Implants
(conical connection) | CrossFit® Connection for
BL/BLT Implants
(conical connection) | CrossFit® Connection for
BL/BLT Implants
(conical connection) | CrossFit® Connection for
BL/BLT Implants
(conical connection) |
| Restoration | Crown and Bridge | Crown | Crown | Bridge |
| Diameter | 3.8 mm, 4.5 mm, and 5.5 mm | 4.5 mm | 3.8 mm | 4.7 mm |
| Gingiva
Height | 1.5 mm | 3.7, 3.8, 5.2 mm | 3.7 mm | 5.2 mm |
| Total
Abutment
Height | 4.5 mm, 6.8 mm | 8.2 mm | 6.5 mm | 6.2 mm |
| Prosthesis
Type | Cemented or screw retained | Cemented or screw-retained | Cemented or screw-retained | Cemented or screw-retained |
| Base Screw | Ti-6Al-7Nb
Basal Screw | Ti-6Al-7Nb
Basal Screw | Ti-6Al-7Nb
Basal Screw | Ti-6Al-7Nb
Basal Screw |
| Maximum
Angulation | 30° | 30° | 30° | 30° |
Table 1 – Comparison Matrix
6
Straumann® BLX Gold Abutments
510(k) Summary
5.7 Performance Data
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility Testing
The subject devices have been assessed for biological safety according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for the subject device.
The subject device is made out of the same material as the primary predicate device, therefore, biocompatibility is represented by the primary predicate. The subject devices are equivalent with regard to nature of body contact, contact duration, material formulation and sterilization methods compared to the primary and reference predicate devices and therefore, no new testing has been performed.
Sterilization
The proposed BLX Gold Abutments are single patient devices and are provided nonsterile. The recommended end user sterilization via Moist Heat Steam sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
Bench Testing
Dynamic fatigue, static strength, and loosening torque tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Testing was performed on worst-case construct. The worst-case construct is based on several device features such as diameter, wall thickness and orientation and intends to represent the performance behavior of all the devices within
7
Straumann® BLX Gold Abutments
510(k) Summary
this submission. The worst-case construct was tested and results demonstrated equivalence to the predicate devices.
5.8 Conclusion
The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the predicate devices.