(90 days)
No
The summary describes dental implants and related components, focusing on materials, sizes, sterilization, and performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for oral implantation to provide a support structure for connected prosthetic devices, restoring chewing function and rehabilitating the upper or lower jaw. This directly addresses medical conditions (edentulous or partially edentulous patients) to improve their health and well-being.
No
The device, Straumann® dental implants and abutments, is intended for oral implantation to provide a support structure for prosthetic devices to restore chewing function. It is a therapy device, not a diagnostic one.
No
The device description explicitly states it is an integrated system of endosseous dental implants with corresponding abutments, healing components, instruments, and prosthetic parts, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for oral implantation to support prosthetic devices for functional and esthetic oral rehabilitation. This involves a surgical procedure and the physical placement of a device within the body.
- Device Description: The device is described as an endosseous dental implant, a physical object designed to be surgically placed in bone.
- 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.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a structural support.
N/A
Intended Use / Indications for Use
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.
They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCl). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.
The purpose of this premarket notification is to extend the BLC and TLC Implants portfolio by including new sizes of implants, more specifically:
BLC implants:
- L 16 mm for diameter Ø 6.5 mm, presented with WB (Wide Base) prosthetic platform.
TLC implants: - L 14 mm and L 16 mm for diameter Ø 5.5 mm, with both implant neck options Standard (2.8 mm height) and Standard Plus (1.8 mm height)
- L 8 mm and L 10 mm for diameter Ø 6.5 mm and implant neck Standard (2.8 mm height)
- L 12 mm to L 16 mm for diameter Ø 6.5 mm, with both implant neck options Standard (2.8 mm height)
and presented with WT (Wide TorcFit) prosthetic platform.
The submission also introduces a new sterilization method using X-ray irradiation which was validated on worst-case test articles representative of the BLC and TLC implant systems.
A summary of the diameter/length implant body combinations is given in Table 1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
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)
Sterilization Validation and Shelf-life:
The subject devices are provided sterile via gamma irradiation at a dose of 25 kGy and will be sterilized after final packaging. The sterilization process for the subject devices as recommended in the labeling was validated to a sterility assurance level (SAL) of 10-6 in accordance with ISO 11137-1:2006, "Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05". The validation method used was the over kill bioburden (or VDmax25) method in accordance with ISO 11137- 2:2013, "Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose". There are no changes to the gamma irradiation sterilization procedures or processes from those of the Straumann primary predicate devices (K230108), the subject devices do not represent a higher challenge to the sterilization process in comparison to the validated worst-case product and validated gamma irradiation sterilization process.
In addition, a validation of the X-ray irradiation as a new sterilization method was conducted. The validation method used was the VDma25. A sterility assurance level (SAL) of 10-6 was validated in compliance with ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05 and ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
The packaging of the subject device is equivalent to the packaging of the primary predicate and reference device. The shelf life for devices provided sterile is 5 years.
The devices will not be marketed as non-pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.
Biocompatibility Testing:
Biological assessment has been performed according to ISO 10993-1 "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 each of the subject devices.
The subject devices are equivalent in material, surface, manufacturing process, packaging materials, sterilization by gamma irradiation, body contact duration compared to the reference device K230108. Sterilization by X-ray irradiation was validated and may be used as an alternative sterilization method instead of gamma irradiation. The impact on the biological safety was evaluated and the needed biocompatibility testing was determined according to the ISO 10993-1:2018 standard. The results of the conducted tests have demonstrated that the assessed devices do not show any reactions with X-ray sterilization that could have a biological effect on the patient at T0 (no aging), T3 (3 years accelerated aging) and T5 (5 years accelerated aging for long-term effect). Thus, the subject devices are considered biologically safe for their intended use according to ISO 10993-1 and FDA's guidance document of ISO 10993-1.
Electromagnetic Compatibility:
There are no significant changes to the materials and dimensions from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices and they can be considered MR Conditional.
The subject implants have obtained the status of MR Conditional per K180540. The MR Conditional tests were conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment".
Performance Testing - Bench:
Insertion tests were performed for the subject implants and it could be proven that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure.
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.
K230108 Straumann® BLC and TLC Implants
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.
K212533 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 20, 2024
Institut Straumann AG % Jennifer Jackson Sr. Director, Regulatory Affairs and Ouality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K234049
Trade/Device Name: Straumann® BLC and TLC Implants - Line extension Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: December 21, 2023 Received: December 21, 2023
Dear Jennifer Jackson:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Straumann® BLC and TLC Implants - Line extension
Indications for Use (Describe)
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.
They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Straumann® BLC and TLC Implants - Line extension
510(k) Summary
1 Submitter's Contact Information
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052
On the behalf of:
Institut Straumann AG
Peter Merian Weg 12
4052 Basel, Switzerland |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS, RAC
Sr. Director, Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By &
Alternate Contact: | Laure Kuhner Borsenberger
Regulatory Affairs and Compliance Manager
Institut Straumann AG
Phone number: +41 79 828 9414 |
| Date of Submission: | March 19, 2024 |
Name of the Device 2
| Trade Names: | Straumann® BLC and TLC Implants - Line extension |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | §872.3640 |
| Device Classification: | II |
| Product Code(s): | DZE |
| Classification Panel: | Dental |
5
Straumann® BLC and TLC Implants - Line extension
510(k) Summary
Predicate Device(s) ന
Primary Predicate:
-
K230108 Straumann® BLC and TLC Implants .
Reference Devices: -
K212533 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants .
Device Description ব
The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCl). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.
The purpose of this premarket notification is to extend the BLC and TLC Implants portfolio by including new sizes of implants, more specifically:
BLC implants:
- L 16 mm for diameter Ø 6.5 mm, presented with WB (Wide Base) prosthetic platform.
TLC implants:
- L 14 mm and L 16 mm for diameter Ø 5.5 mm, with both implant neck options Standard (2.8 mm height) and Standard Plus (1.8 mm height)
- L 8 mm and L 10 mm for diameter Ø 6.5 mm and implant neck Standard (2.8 mm height)
- L 12 mm to L 16 mm for diameter Ø 6.5 mm, with both implant neck options Standard (2.8 mm height) and Standard Plus (1.8 mm height)
and presented with WT (Wide TorcFit) prosthetic platform.
The submission also introduces a new sterilization method using X-ray irradiation which was validated on worst-case test articles representative of the BLC and TLC implant systems.
A summary of the diameter/length implant body combinations is given in Table 1.
6
Straumann® BLC and TLC Implants - Line extension
| BLC implant | TLC implant | ||
|---|---|---|---|
| Implant Diameter | $\varnothing$ 6.5mm | $\varnothing$ 5.5mm | $\varnothing$ 6.5mm |
| Implant Length | - | - | 8 mm - S |
| - | - | 10 mm - S | |
| - | - | 12 mm - S & SP | |
| - | 14 mm - S & SP | 14 mm - S & SP | |
| 16 mm | 16 mm - S & SP | 16 mm - S & SP | |
| Prosthetic platforms | WB | WT | WT |
510(k) Summary
Table 1 - Overview of diameter/length implant body combinations
Intended Use 5
Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.
Indications for Use 6
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.
They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multipletooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Technological Characteristics 7
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following table:
7
Straumann® BLC and TLC Implants - Line extension
510(k) Summary
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE | REFERENCE DEVICE | EQUIVALENCE |
|---|---|---|---|---|
| K Number/ | ||||
| name | K234049 | |||
| BLC & TLC Implant Line extension | K230108 | |||
| Straumann® BLC and TLC Implants | K212533 | |||
| BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 | ||||
| mm (L14 and L16) Implants | DISCUSSION | |||
| Indications | ||||
| for Use | Straumann® dental implants are | |||
| indicated for the functional and esthetic | ||||
| oral rehabilitation of the upper or lower | ||||
| jaw of edentulous or partially edentulous | ||||
| patients. They can be used for | ||||
| immediate, early or late implantation | ||||
| following the extraction or loss of natural | ||||
| teeth. The implants can be placed with | ||||
| immediate function for single-tooth | ||||
| and/or multiple-tooth restorations when | ||||
| good primary stability is achieved and | ||||
| with appropriate occlusal loading to | ||||
| restore chewing function. | Straumann® dental implants are | |||
| indicated for the functional and esthetic | ||||
| oral rehabilitation of the upper or lower | ||||
| jaw of edentulous or partially edentulous | ||||
| patients. They can be used for | ||||
| immediate, early or late implantation | ||||
| following the extraction or loss of natural | ||||
| teeth. The implants can be placed with | ||||
| immediate function for single-tooth | ||||
| and/or multiple tooth restorations when | ||||
| good primary stability is achieved and | ||||
| with appropriate occlusal loading to | ||||
| restore chewing function. | Straumann® dental implants are | |||
| indicated for the functional and | ||||
| esthetic oral rehabilitation of the | ||||
| upper or lower jaw of edentulous or | ||||
| partially edentulous patients. They | ||||
| can be used for immediate, early or | ||||
| late implantation following the | ||||
| extraction or loss of natural teeth. | ||||
| The implants can be placed with | ||||
| immediate function for single-tooth | ||||
| and/or multiple-tooth restorations | ||||
| when good primary stability is | ||||
| achieved and with appropriate | ||||
| occlusal loading to restore chewing | ||||
| function. | Identical to primary | |||
| predicate and | ||||
| reference device | ||||
| Material | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy (Roxolid®) | Titanium-13 Zirconium alloy | |
| (Roxolid®) | Identical to primary | |||
| predicate and | ||||
| reference device | ||||
| Surface | ||||
| Treatment | Hydrophilic SLActive® | Hydrophilic SLActive® and SLA® | Hydrophilic SLActive® and SLA® | Identical to primary |
| predicate and | ||||
| reference device | ||||
| Implant to | ||||
| Abutment | ||||
| Connection | TorcFit | |||
| (with conical fitting) | TorcFit | |||
| (with conical fitting) | TorcFit | |||
| (with conical fitting) | Identical to primary | |||
| predicate and | ||||
| reference device | ||||
| Implant | ||||
| Diameter and | ||||
| Length | BLC implants: | |||
| Ø 6.5: 16 mm | ||||
| TLC implants: | ||||
| Ø 5.5: 14 and 16 mm (S and SP) | ||||
| Ø 6.5: 8 and 10 mm (S only) | ||||
| Ø 6.5: 12, 14, 16 mm (S and SP) | BLC implants: | |||
| Ø 3.3: 8, 10, 12, 14, 16, 18 mm | ||||
| Ø 3.75 and 4.5: 6, 8, 10, 12, 14, 16, 18 mm | ||||
| Ø 5.5: 6, 8, 10, 12, 14, 16 mm | ||||
| Ø 6.5: 6, 8, 10, 12, 14 mm | ||||
| TLC implants: | ||||
| Ø 3.3: 8, 10, 12, 14, 16, 18 mm (S and SP) | ||||
| Ø3.75 and 4.5: 6, 8, 10, 12, 14, 16, 18 mm (S and SP) | ||||
| Ø 5.5: 6, 8, 10, 12 mm (S and SP) | ||||
| Ø 6.5: 6 mm (S and SP) | ||||
| Ø 6.5: 8 and 10 mm (SP only) | Ø 5.0: 18 mm | |||
| Ø 5.5 and 6.5: 14 and 16 mm | Extension of primary | |||
| predicate, implantable | ||||
| dimensions identical to | ||||
| reference device | ||||
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION |
| K Number/ name | K234049 | |||
| BLC & TLC Implant Line extension | K230108 | |||
| Straumann® BLC and TLC Implants | K212533 | |||
| BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | ||||
| Implant Design | Apically tapered Bone Level implant and | |||
| Apically tapered Tissue Level implant | Apically tapered Bone Level implant and | |||
| Apically tapered Tissue Level implant | Fully tapered Bone Level implant | Identical to primary predicate | ||
| Thread Pitch | 1.15 mm | 0.8, 0.9, 1 and 1.15 mm | 2.5 to 3.1 mm | Identical to primary predicate |
| Sterilization Method | Irradiation | |||
| (gamma and x-ray) | Irradiation | |||
| (gamma) | Irradiation | |||
| (gamma) | Equivalent to primary predicate and reference device. | |||
| The two sterilization methods are comparable in terms of their sterilization principle (photons), with some technical advantages for X-ray such better dose uniformity, less oxidative stress for certain materials and processing time. | ||||
| Both methods are validated by Straumann. |
8
Straumann® BLC and TLC Implants - Line extension
510(k) Summary
Table 2 – Comparison matrix: subject device versus primary predicate and reference device
9
Traditional 510(k) Submission - K234049 Straumann® BLC and TLC Implants - Line extension
Performance Testing 8
Sterilization Validation and Shelf-life
The subject devices are provided sterile via gamma irradiation at a dose of 25 kGy and will be sterilized after final packaging. The sterilization process for the subject devices as recommended in the labeling was validated to a sterility assurance level (SAL) of 10° in accordance with ISO 11137-1:2006, "Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05". The validation method used was the over kill bioburden (or VDmax25) method in accordance with ISO 11137- 2:2013, "Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose". There are no changes to the gamma irradiation sterilization procedures or processes from those of the Straumann primary predicate devices (K230108), the subject devices do not represent a higher challenge to the sterilization process in comparison to the validated worst-case product and validated gamma irradiation sterilization process.
In addition, a validation of the X-ray irradiation as a new sterilization method was conducted. The validation method used was the VDma25. A sterility assurance level (SAL) of 10 ° was validated in compliance with ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05 and ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
The packaging of the subject device is equivalent to the packaging of the primary predicate and reference device. The shelf life for devices provided sterile is 5 years.
The devices will not be marketed as non-pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.
10
Traditional 510(k) Submission - K234049 Straumann® BLC and TLC Implants - Line extension
Biocompatibility Testing
Biological assessment has been performed according to ISO 10993-1 "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 each of the subject devices.
The subject devices are equivalent in material, surface, manufacturing process, packaging materials, sterilization by gamma irradiation, body contact duration compared to the reference device K230108. Sterilization by X-ray irradiation was validated and may be used as an alternative sterilization method instead of gamma irradiation. The impact on the biological safety was evaluated and the needed biocompatibility testing was determined according to the ISO 10993-1:2018 standard. The results of the conducted tests have demonstrated that the assessed devices do not show any reactions with X-ray sterilization that could have a biological effect on the patient at T0 (no aging), T3 (3 years accelerated aging) and T5 (5 years accelerated aging for long-term effect). Thus, the subject devices are considered biologically safe for their intended use according to ISO 10993-1 and FDA's guidance document of ISO 10993-1.
Electromagnetic Compatibility
There are no significant changes to the materials and dimensions from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices and they can be considered MR Conditional.
The subject implants have obtained the status of MR Conditional per K180540. The MR Conditional tests were conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment".
Performance Testing - Bench
Insertion tests were performed for the subject implants and it could be proven that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure.
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Traditional 510(k) Submission - K234049 Straumann® BLC and TLC Implants - Line extension
The subject device surface treatments are identical to the surface treatments of the primary predicate and reference devices. The SLActive® surface treatment is a sand-blasted, large grit, acid etched, chemically active and hydrophilic surface is routinely tested by roughness measurement or scanning electron microscopy.
Conclusion
The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference devices.