(338 days)
The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.
The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.
The Zeramex® P6 implants are intended for delayed loading.
The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.
The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.
The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools.
The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm. 4.1 mm. and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected.
Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN: 4.0mm) and regular neck (RN. 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants.
The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions.
The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.
Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ.
The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185).
The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) PEEK-Optima™ Ultra (Endolign) screws (provided as straight and angular screws in SN and RN sizes).
Healing caps and gingiva formers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingiva formers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Zeramex® P6 Dental Implant System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., a specific percentage for success rates or a certain threshold for complications). Instead, it describes a retrospective clinical study and non-clinical tests whose positive results support the substantial equivalence claim.
However, based on the non-clinical and clinical study outcomes, we can infer the implied acceptance criteria from the reported success:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Non-Clinical: | |
| Cleaning and Sterilization Validation (ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2) | Device met standards (implied by positive review). |
| Shelf-life, Packaging, and Transport Validation (ASTM F1980, ASTM F88, ASTM F1886, ASTM F1929, ISO 11607-1, ISO 11607-2) | Device met standards (implied by positive review). |
| Biocompatibility (ISO 10993-5) | Device met standards (implied by positive review). |
| Surface Chemical & Roughness Analysis (XPS, SEM, Contact Angle) | Analysis performed; results support design (implied by positive review). |
| Fatigue Testing (ISO 14801, for new and aged samples) | Device met standards (implied by positive review). |
| Clinical: | |
| Absence of Post-operative Complications (e.g., anesthesia, paresthesia, mandibular fracture, alveolar ridge height loss, adverse impact on adjacent teeth, abnormal/prolonged pain, fistula, infection, osteomyelitis) | No complications reported at implant placement, loading, and follow-up (up to >1 year). |
| Absence of Adverse Reactions (e.g., infection, pain, altered sensation, TMJ problems, implant loss, implant breakage, abutment breakage) | No adverse reactions reported at implant placement, loading, and follow-up (up to >1 year). |
| Absence of Screw Issues (movement, fracture, replacement) | No reports of screw movement, fracture, or replacement. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): 19 patients, receiving a total of 35 screw-retained abutments. Follow-up data was obtained on 15 of those patients (representing 27 screw-retained abutments). Specific follow-up numbers are:
-
6 months follow-up: 8 patients
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1 year follow-up: 3 patients
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- Data Provenance: Retrospective clinical data. The country of origin is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish a "ground truth" for the retrospective clinical test set. The data appears to rely on clinical observations and professional documentation from the treatment of the 19 patients. It's implied that the treating clinicians (dentists/surgeons) made the assessments of complications and adverse events.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical test set data. Given it's retrospective clinical data, it's highly likely that the outcomes were recorded as part of routine patient care, without a formalized independent adjudication process mentioned for the purpose of this 510(k) submission. Therefore, the adjudication method is effectively "none" in the context of this regulatory submission.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the safety and performance of the device itself, not on comparing differences in human reader performance with or without AI assistance, as the device is a dental implant system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Zeramex® P6 Dental Implant System is a physical medical device (dental implant and associated components), not an algorithm or software-as-a-medical-device (SaMD). Therefore, "standalone algorithm performance" is not relevant to this submission.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was based on clinical observations and outcomes data from real patients. This includes:
- Absence of complications (e.g., infection, pain, fracture).
- Absence of adverse events.
- Stability and function of the implant and abutment over time.
For the non-clinical studies, the "ground truth" was established by adherence to recognized international and national standards (e.g., ISO, ASTM) for material properties testing, biocompatibility, sterilization validation, and fatigue strength.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. This is a traditional medical device submission, not an AI/ML device. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned or implied for an AI/ML device, this question is not applicable.
§ 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.