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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components previously cleared K200992, K193096, K170398 and K170392.

This submission adds Interface Abutments and Healing Abutments to the S.I.N. Dental Implant System. The subject device Interface abutments are provided with MT 16º and CM11.5º connection compatible with the S.I.N. Dental implants.

Subject Device Interface Abutments

Subject device Interface Abutments are two-piece abutments for which the second part (or top half) is the ceramic superstructure. The second part is designed and manufactured using CAD-CAM techniques. The titanium component of the Interface Abutments has a cementable platform diameter of 3.5mm, 4.0mm, 4.5mm, or 5.5mm, cementable post-height of 4.0mm or 6.0mm, and a gingival height built into the titanium base component from 0.5mm to 4.0 mm. The two pieces of the Ti-Base are bonded using Panavia Universal Dual-Cure Cement (K150704), as referenced in K190936.

All subject devices are provided only in straight designs, with no pre-angled conventional abutments or pre-angled CAD-CAM abutments. No subject device abutment is to be customized to create an angled abutment or to correct for angulation, and no superstructure for use with any subject device Interface abutment (CAD-CAM) is to be fabricated to create a final abutment with angulation or to correct for angulation. Therefore, this model has a slight design difference to improve screw insertion and removal. It was purposely designed to optimize fixation and removal of the screw connection. This new presentation allows screw fixation even in cases of anterior aesthetic rehabilitation, avoiding the need to create screw access holes in the sublingual phase. However, it is confirmed that all implant-abutment interfaces are intended exclusively for straight configurations and are not indicated for any angled model. These minor differences in the exact dimensions of the subject device interface abutment as compared to the predicate device and reference devices do not impact safety, effectiveness, or substantial equivalence.

The subject device interface abutments with the CM11.5º interface are compatible with implants cleared in K200992, K221453, K211921 and K170392 in terms of abutment-implant connection. The subject device with the MT16º interface is compatible with implants cleared in K222231, K193096 and K170392 in terms of abutment-implant connection.

The design parameters for the CAD-CAM fabrication of patient-specific abutments from CADCAM Abutments are the same for the 11.5° CM implant connection and the MT 16° implant connection. The design limit parameters are:

• Minimum wall thickness – 0.5 mm
• Minimum abutment post height for single-unit restoration – 4.0 mm
• Maximum angle – 0°. Straight only
• Maximum angle for screw insertion/removal – 20º
• Maximum gingival height – 5.0mm
• Minimum Gingival Height – 0.5 mm
• Maximum allowable abutment Post Height – 6 mm
• Total Abutment Height – 10mm

By definition, the abutment post height is considered by FDA to be the "stump" portion above the gingival collar, to which the restorations attach.

All subject device Interface Abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and the same zirconia that is specified for superstructures in K190396, and are to be used with subject abutment screws. All subject devices are provided sterile. All Interface abutments are provided sterile by gamma irradiation; the same sterilization method used in predicate device K190396 and in the additional devices K200992 and K170392.

All Interface abutments manufactured form titanium alloy are anodized using a standard anodization process is identical to the anodization process used on abutments cleared in K190396.

The subject device abutments screws are to be used with Interface Abutments present in this submission and they are substantially equivalent to material (titanium alloy) and designs to abutments screws cleared in K170392.

Subject Device Healing Caps

The subject device Healing Cap is substantially equivalent to the corresponding design Healing Cap cleared in K170392. The subject device healing cap is designed for the healing period between implant placement and final abutment placement and is not intended to support a temporary prosthesis.

All Healing Caps are provided sterile by gamma irradiation; the same sterilization method used in predicate device K170392 and additional predicate device K200992.

All subject device components are provided sterile by gamma irradiation, the same sterilization method used in K190936, K170392 and K200992.

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The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

DSP Implant System is composed of the External Hex (HE) implant line is composed of implants and related prosthetic components available in multiple designs. DSP implants are made of commercially pure titanium (ASTM F67). DSP prosthetic components are made of commercially pure titanium or cobalt-molybdenum alloy (ASTM F1537). DSP implant system screws (abutment and prosthetic screws) are made of titanium alloy (ASTM F136). The HE implant line is named after the External Hex implant-to-abutment interface. It is subdivided in External Hex SLIM (HE SLIM), External Hex BIOFIT), External Hex SOULFIT (HE SOULFIT), External Hex PROPFIT (HE PROPFIT) and External Hex WAYFIT). The HE implants are bone-level implants. The subject device abutments components mate exclusively with the subject implants of the same line.

This is a 510(k) summary for the DSP Implant System, a dental implant device. It establishes substantial equivalence to various predicate devices rather than providing performance data against specific acceptance criteria for the new device. Therefore, it does not present a typical study design with acceptance criteria and results in the way a clinical trial or device performance study would.

However, based on the provided text, we can infer the approach taken by the manufacturer to demonstrate substantial equivalence, which serves as their "proof" that the device meets regulatory requirements.

Here's an interpretation of the requested information based on the 510(k) summary:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission focusing on substantial equivalence, there isn't a table of discrete acceptance criteria and reported device performance in terms of clinical outcomes or specific quantitative measures as one might find in a standalone performance study. Instead, the "acceptance criteria" are implied by the characteristics of the legally marketed predicate devices, and the "reported device performance" is the demonstration that the subject device shares these characteristics or has equivalent performance as validated through non-clinical testing.

The acceptance is based on demonstrating that the DSP Implant System is substantially equivalent to the predicate devices in terms of:

• Intended Use: The indications for use statement of the subject device is equivalent to the primary predicate device K101207, and within the scope of reference devices.
• Technological Characteristics: The subject device's design features, materials (CPTi Gr4, CoCr, POM, Ti6Al4V-ELI), sterilization methods (irradiation), and surface treatments (grit-blasted and acid-etched, machined collar) are compared to the predicate and reference devices. Minor differences are justified as not raising new questions of safety or effectiveness.
• Performance: Non-clinical testing demonstrates that the device performs comparably to the predicate devices in relevant areas for dental implants.

Implicit Acceptance Criteria and Reported Device Performance (based on substantial equivalence justification):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable for a typical clinical or performance study as presented in this 510(k). The "testing" referred to is non-clinical bench testing (sterilization, biocompatibility, pyrogenicity, material analysis). These tests typically use a representative sample size specified by the relevant standard (e.g., a certain number of devices for sterility testing). The document does not specify these individual sample sizes.
• Data Provenance: The data is non-clinical (bench testing) and generated by the manufacturer to support device characteristics. The 510(k) is submitted by a Brazilian manufacturer (D.S.P. Industrial Eireli) and prepared by a Brazilian regulatory affairs specialist (PR Servicos Regulatorios Administrarivos Ltda). The location of the actual testing labs is not specified. The studies are not clinical, so concepts like "retrospective" or "prospective" do not apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a non-clinical submission. Ground truth, in the sense of expert opinion on clinical data, is not established. The "ground truth" for the non-clinical tests is established by the specifications of the referenced international and national standards (ISO, ASTM, USP, AAMI/ANSI).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically for evaluation of conflicting expert opinions or clinical outcomes, which is not the nature of this non-clinical submission.

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

• No. This is a submission for a dental implant system (hardware), not an AI/software device. An MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This is a physical medical device. Not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the non-clinical performance data, the "ground truth" is defined by the requirements and test methodologies of the referenced industry standards (e.g., ISO 11137 for sterilization, ISO 10993-5 for biocompatibility, AAMI/ANSI ST72 and USP <85> for pyrogenicity, SEM/EDS for material analysis). The demonstration is that the device conforms to these standards and shares equivalent characteristics with legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of device.

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