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Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

Straumann® BLX Dental Implants, SLActive®
Straumann® dental implants are indicated for 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® TLX Dental Implants, SLActive®
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.

Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. Unless stated in specific indications, 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.

Specific indications for use
Straumann® Roxolid® Bone Level Tapered Implant ø 2.9 mm
The Straumann® Roxolid® Bone Level Tapered implants ø 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw.

Straumann® Roxolid® Standard Plus 4 mm Short Implants
Straumann® Roxolid® Standard Plus 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.

Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for:
Fixed denture prosthesis/splinted units (one implant per unit).
Pontic cases in combination with at least one longer implant.
Fully edentulous cases with at least one Straumann® Roxolid® Standard Plus 4 mm Short Implants in combination with 2 longer implants in the anterior region and at least four total implants.

Titanium Ø 3.3 mm implants
ø3.3 mm S and SP RN implants are to be used only for the following indications:
Partially dentate jaws with implant-borne, fixed constructions: combine with a Ø4.1 mm implants and splint the superstructure.

The SLActive® Implants from the Straumann® Dental Implants System includes:
SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10, and 12 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 NNC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.1 RN and Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø2.9 SC 10, 12 and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, 14. 16 and 18 mm
SLActive® and Roxolid®, BLX, Ø3.5 RB, 8, 10, 12, 14, 16, 18 mm
SLActive® and Roxolid®, BLX, Ø3.75 RB, Ø4.0 RB, Ø4.5 RB and Ø5.0 RB, 6, 8, 10, 12, 14, 16. 18 mm
SLActive® and Roxolid®, BLX, Ø5.5 WB and Ø6.5 WB, 6, 8, 10, 12, 14 and 16 mm
SLActive® and Roxolid®, Standard, TLX, Ø3.75 NT, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus Short, Ø4.1 RN and Ø4.8 RN and WN, 4 mm 4 mm Short Implants

The device being discussed is "Straumann® SLActive® labeling changes" (K223083). This 510(k) pertains to labeling changes for existing Straumann® SLActive® dental implants and does not introduce new implants or modify existing implant designs. The primary predicate device is K171784 – Straumann Dental Implant System, with several other Straumann® implant systems listed as reference devices.

The acceptance criteria and supporting study are primarily focused on substantiating the updated labeling, particularly regarding the use of SLActive implants in smokers and general wording clarifications.

1. Table of Acceptance Criteria and Reported Device Performance

• All indications continue to allow for implant placement in the jaw, providing support for single-tooth or multiple-tooth restorations, and allowing for immediate loading when good primary stability is achieved.
• Information regarding prosthetic restorations was not excluded but relocated to the device description for better understanding.
• The requirement for "4 or more implants for fully edentulous patients" was removed from indications for use as it is considered "common knowledge."
• New specific Indications for Use for Ø 3.3 mm implants provide more details.
• The "Precaution" section of the Instructions for Use now addresses the use of narrow implants in the molar region.
• For specific implant types (e.g., BLX implants), the single-tooth restoration was considered the "worst case due to the higher masticatory load," indicating an understanding of potential stress. |
  | For "Smokers' Claim" (Outcomes of SLActive implants in smokers are encouraging):
  Supported by clinical evidence demonstrating that implant performance (e.g., failure rates, adverse events) is not significantly worse in smokers compared to non-smokers with SLActive implants.
  Demonstrated through systematic literature review or clinical studies. | A systematic literature search identified 5 publications.
• 251 SLActive implants were placed in 237 patients (age range 25-65 years old).
• Studies included titanium or titanium-zirconium alloy implants with SLActive surfaces, diameters 3.3-4.8 mm, and lengths 8-12 mm.
• Reported adverse events (failure to osseointegrate, peri-implantitis, spinning/mobility during surgery, late failure, bone loss, abutment loosening, paresthesia, acrylic/porcelain chipping) were not reported at a higher rate in smokers compared to non-smokers.
• Implant failure rates were not found to be significantly different in smoking compared to non-smoking patients with SLActive implants.
• References: Alsahhaf A (2019), Xiao W (2021), Chen Y (2017), Sener T (2010), Luongo G (2016). (Note: Sener and Luongo were cited in the text but not fully listed in the provided references section). |
  | Sterility:
  Sterilization process validated to SAL of 10^-6.
  Meets pyrogen limit specifications. | - Sterilization via gamma irradiation after final packaging.
• Validated to a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137-1 and ISO 11137-2 (VDmax25 method).
• Pyrogen limit specifications met with LAL Endotoxin Analysis, testing limit of 20 EU/device (per FDA Guidance and ISO 10993-1). |
  | Biocompatibility:
  Biological assessment performed according to ISO 10993-1 and FDA Guidance. | - Biological assessment performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1..." for each device. (Results are not detailed but the assessment was stated to be performed). |
  | Dynamic Fatigue:
  Assessment conducted per FDA guidance and ISO 14801. | - Dynamic fatigue assessment conducted according to FDA guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801.
• Test covers permanent restoration of implants without failure. (Results are not detailed but the assessment was stated to be performed). |
  | Insertion Performance:
  Demonstrated adequate insertion torque in different bone classes. | - Insertion tests performed for the subject implants.
• Showed adequate insertion torque in different bone classes when inserted according to the surgical procedure. (Results are not detailed but the assessment was stated to be performed). |
  | MR Safety:
  Evaluated for MR Conditional status. | - Obtained MR Conditional status per K180540.
• MR Conditional tests conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment." (Results are not detailed but the status was noted). |

2. Sample Size Used for the Test Set and Data Provenance

The core of the "study" for the labeling changes, especially concerning the "smokers' claim," was a systematic literature review, not a direct clinical trial conducted by the applicant for this 510(k).

• Sample Size for Smokers' Claim: The literature review included data from 5 publications which collectively involved 251 SLActive implants placed in 237 patients.
• Data Provenance: The data came from published clinical studies. The document does not specify the exact country of origin for all studies, but at least two cited papers involve authors from China (Xiao, Chen), one from Saudi Arabia (Alsahhaf), and the ITT World Symposium (Chen 2017) was held in Switzerland. The studies are explicitly described as "clinical studies," implying they were prospective or retrospective clinical investigations.

For other non-clinical performance characteristics (sterility, biocompatibility, dynamic fatigue, insertion tests, MR safety), these appear to be internal bench tests and assessments conducted by the manufacturer, or previously established for the cleared predicate/reference devices. No specific sample sizes for these tests are provided in this summary, but it's stated that "No significant changes have been performed to the subject implants since clearance so previously cleared bench data continue to be representative."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• For the "smokers' claim" (literature review): The "ground truth" (i.e., the reported outcomes like adverse event rates and implant failure rates) was established by the authors of the original 5 clinical publications. The document does not specify the qualifications of these individual authors. However, given they are "published clinical studies," it's understood that dental/medical professionals (e.g., oral surgeons, periodontists, implantologists) would have conducted these studies and reported the outcomes.
• For the equivalence discussion of Indications for Use: The "ground truth" is established by comparing the proposed wording against the previously cleared wording in the primary and reference predicate devices, which were approved by the FDA based on clinical and scientific evidence at the time of their clearance. This comparison itself is performed by regulatory affairs experts on behalf of the manufacturer.

4. Adjudication Method for the Test Set

• For the "smokers' claim" (literature review): The adjudication of adverse events and implant failure rates was performed within each of the original 5 clinical studies. The specific adjudication methods used in those individual studies are not detailed in this 510(k) summary. Given the nature of scientific literature, these studies would typically involve clinical follow-up and assessment by the treating clinicians/researchers.
• For the Indications for Use equivalence: This is a comparison process, not a clinical adjudication. The equivalence of wording is assessed by regulatory experts against the historical FDA clearances.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was NOT done. This submission is for labeling changes for dental implants, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Not applicable. This submission is for a medical device (dental implants), not a software algorithm or AI.

7. The Type of Ground Truth Used

• For the "smokers' claim": The ground truth was clinical outcomes data reported in peer-reviewed published clinical studies. These outcomes included adverse events (e.g., failure to osseointegrate, peri-implantitis, bone loss) and implant failure rates.
• For other performance tests (sterility, fatigue, etc.): The ground truth would be established through defined bench testing protocols and adherence to international standards (e.g., ISO, FDA guidance).

8. The Sample Size for the Training Set

• Not applicable. This submission is not for a machine learning or AI device that requires a training set. The "smokers' claim" was based on a literature review which leverages existing published clinical data, akin to an external validation set rather than a training set for the current submission.

9. How the Ground Truth for the Training Set was Established

• Not applicable. (See point 8.)

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