(121 days)
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
This premarket notification serves to affect a labeling change applicable to all endosseous dental implants of the Straumann® Dental. Implant System. The subject devices are physically identical to the listed predicate device descriptions are identical to those presented in the referenced predicate submissions.
The proposed Straumann Implant Instructions for Use (IFU) changes in this premarket notification are to address the following:
- Update the IFU content to reflect the FDA Guidance on Medical Device Patient . Labeling regarding contraindications, general warnings, and precautions
- Clarify the term "poor bone metabolism" under contraindications and move the . condition "osteoporosis" to Precautions in the IFU
- Modify the indications for use statement previously cleared in premarket notifications . K081419 and K083550 to relocate the statement regarding specific indications for small diameter (Ø3.3 mm) implants from the indications for use to the Precautions
This 510(k) summary describes a labeling change for the Straumann® Dental Implant System, not a new device or software with performance metrics like sensitivity and specificity. Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this submission.
The "acceptance criteria" here refer to the regulatory acceptance of the proposed labeling changes, based on a clinical study and literature review supporting those changes.
Here's the breakdown of the information that is applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Related to Labeling Changes) | Reported Device Performance (Supporting Evidence) |
|---|---|
| Justification to move "osteoporosis" from Contraindications to Precautions. | Clinical Literature Review: "The available data indicate that metabolic disease of the bone is not a strict contraindication for the use of dental implants; the evidence supports that performance of dental implants in patients whose metabolic bone disease is pharmacologically under control is equivalent to those in patients free of metabolic bone disease." This supports allowing the clinician to determine suitability based on individual patient assessment. |
| Justification to move "specific indications for small diameter (Ø3.3 mm) implants in the molar region" from Indications for Use to Precautions. | Non-Interventional Clinical Study (Subset Data): |
- Purpose: To determine implant success and survival rates one year after implant placement, partly assessing the performance of Ø3.3 mm Roxolid implants in the molar region.
- Results: As of the 2-year time point in the molar region, there were two reported implant failures (one prior to restoration, one prior to 1-year mark post-restoration). No implant failure was reported after the 1-year follow-up in the molar region. Other adverse events included two cases of inflammation, one case of poor implant stability, and one case of peri-implant resorption. Most resolved.
- Conclusion: "This clinical data suggest that performance of Roxolid Ø3.3 mm implants placed in the molar region is equivalent to those placed in other parts of the mouth." This supports allowing the clinician to determine whether application in the molar region is appropriate for the particular patient. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (for the non-interventional clinical study subset): Not explicitly stated as a separate numerical value for the subset of data focusing on the molar region. The study "included subjects with the need of dental implant therapy and restoration according to the cleared indications for the Roxolid Ø3.3 mm implant."
- Data Provenance: Retrospective (post-market) non-interventional study in humans. Countries of origin include Germany, United Kingdom, France, Spain, Sweden, the United States, and Canada.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. The "ground truth" for this submission is based on clinical outcomes observed in a post-market study and a review of existing clinical literature by the manufacturer, rather than expert consensus on a specific test set.
4. Adjudication Method for the Test Set
- Not Applicable. This was a non-interventional clinical study where outcomes were observed and reported, not a study requiring adjudication of interpretations of data by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This submission is for a dental implant system, not an AI-powered diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This submission is for a dental implant system, not an algorithm.
7. The Type of Ground Truth Used
- For the clinical literature review: Published clinical evidence and consensus within the scientific community regarding metabolic bone diseases and dental implant outcomes.
- For the non-interventional clinical study: Observed clinical outcomes such as implant success, survival rates, changes in bone level, and adverse events, as documented by investigators.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this traditional 510(k) for a labeling change on a physical medical device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 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.