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The Surcam Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The C Type 3.3mm diameter implants are indicated for use with only straight abutments.

Temporary cylinders must be used in a splinted restoration only and are not for single crown restorations.

The Surcam Dental Implant System consists of endosseous dental implants in conical and internal hex connections along with abutments, cover screws, healing caps and abutment systems for each connection type. Conical devices come in two platforms, NP and RP. Implants and abutments are made from ASTM F136 Ti6AL4V ELI. Multi-unit abutments are for multi-unit restorations only.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is a 510(k) premarket notification for a medical device called the "Surcam Dental Implant System," which is a traditional dental implant system, not an AI device.

The document discusses:

• Device Name: Surcam Dental Implant System
• Indications for Use: Surgical and restorative applications for placement in the bone of the upper or lower jaw to support prosthetic devices (artificial teeth) to restore chewing function. It also indicates immediate loading when good primary stability is achieved.
• Device Description: Consists of endosseous dental implants (conical and internal hex connections), abutments, cover screws, healing caps, and abutment systems. Made from ASTM F136 Ti6AL4V ELI.
• Testing Summary: Dynamic fatigue testing (ISO 14801), surface cleanliness analysis, sterilization (ISO 11137-1 and 11137-2 for implants; ISO 17665-1 and -2 for abutments), material compliance (ASTM F136), endotoxin testing (USP 161), shelf life and package integrity testing (ASTM F1980, ASTM F1929, ASTM 2338, ASTM D3078, ISO 11607-1) for a shelf life of 5 years.
• MR Environment Condition: Non-clinical worst-case MRI review performed based on scientific rationale and published literature.
• Predicate and Reference Devices: Comparison with other legally marketed dental implant systems to establish substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the subject of this document is a conventional dental implant system.

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Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Surgikor Abutment Blanks and Abutments are intended to be used in conjunction with Surgikor endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

All digitally designed abutments for use with Surgikor Abutment Blanks are intended to be sent to a Surgikor validated milling center for manufacture.

The Surgikor Fixation One implant is an alternative version of the 4.3 and 5.0 mm diameter Fixation implants that uses the regular platform used by the 3.5mm Fixation implants. The Surgikor abutment blanks and abutments consist of hexagonal and conical abutments made from abutment blanks, an additional hexagonal healing cap, and multi-unit abutments for conical RP and WP. Surgikor implants and abutments are made from Ti6AL4V ELI.

Fixation One is a root form implant that is appropriate for both immediate load applications and insertion into fresh extraction sockets. Fixation One is offered with a conical connection in regular platform. The Fixation One regular platform implant is available in 4.3, and 5.0 mm diameter and has available lengths of 8.5, 10, 11.5, 13, 15, and 18 mm.

Healing cap for internal hex in 3.75mm x 7mm in standard emergence.

Multi-Unit Abutment in conical RP and WP are available in heights of 1.5, 2.5, and 3.5 mm. An angled multi-unit of either 17° (2.5 or 3.5 mm) or 30° (3.5 or 4.5 mm) is available for conical connections of regular and wide platform. Multi-unit abutments are intended for multiple unit restorations only. Angled multi-units use RP and WP conical multi-unit screws.

Surgikor Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Surgikor Blank Abutments have an engaging implant connection. Abutments made from Surgikor Blank Abutments use internal hex abutment screws and RP & WP conical abutment screws from K182615.

The design parameters for customized abutments fabricated from Titanium Blank Abutments are: Minimum wall thickness – 0.4 mm Minimum post height for single-unit restorations (length above the abutment collar / gingival height)— 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height – 6.7 mm Maximum angulation - 25° (in relation to the long axis of the implant)

All abutment blanks are made of titanium alloy conforming to ASTM F136. Abutments made from the blanks are only for use with Surgikor dental implants of the implant/abutment interface on the package label and are not to be used with other dental implant designs. This includes Versatile Hex 3.5mm and larger, Immediate Hex 3.75mm and larger, and Solution Fixation & Fixation One conical 3.5mm and larger.

There are 3 models of abutment blank: internal hex, conical RP and conical WP.

Minimum diameter at abutment/implant interface: Versatile Hex 3.5mm Immediate Hex 3.75mm Solution 3.5mm Fixation 3.5mm Fixation One 4.3mm

Maximum length of abutment from abutment/implant interface: Versatile and Immediate Hex 13.00mm Solution 9.5mm Fixation and Fixation One 9mm

The provided text is a 510(k) Premarket Notification from the FDA regarding the Surgikor Fixation One, Abutment Blanks, and Abutments. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, not on proving that a device meets specific acceptance criteria through a clinical or performance study involving an AI algorithm or human readers.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system because:

• The document is for a dental implant system (physical medical devices), not an AI algorithm or software. The "device" in question (Surgikor Fixation One, Abutment Blanks, and Abutments) is a set of physical components used in dental implant procedures, made from Ti6AL4V ELI material.
• The "study" discussed is a demonstration of substantial equivalence. This involves comparing the new device's indications for use, materials, design, principles of operation, and sterilization to legally marketed predicate devices. It does not involve performance metrics like sensitivity, specificity, or human improvement with AI assistance.
• There is no mention of algorithms, AI, human readers, or image analysis. The testing summary mentions cytotoxicity, steam sterilization, gamma irradiation validation, LAL testing, shelf-life, surface assessment, bench testing, and an MRI environment review, all related to the physical properties and safety of the dental implants.

The document does not contain any of the information required to populate the fields related to acceptance criteria for an AI-powered diagnostic device.

Summary of why the requested information cannot be extracted from the provided text:

The document describes a 510(k) submission for mechanical dental implants and abutments. It focuses on demonstrating "substantial equivalence" to existing predicate devices, rather than presenting a performance study of an AI-driven system or a system involving human interpretation of data. Therefore, details such as algorithm performance, sample sizes for AI training/testing sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI models are not present.

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The TOV Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Maer, Ragil and TCX are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Ragil 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

The TOV Dental Implant System contains 2 designs of internal hex implants and various types of abutments as described below as well as 1 design of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user.

Maer implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Maer comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm in 6.0mm diameter).

Ragil implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Ragil comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth.

Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available.

Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm.

Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm.

Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm.

Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm.

Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm.

Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified.

Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.

Internal Hex Double Loc Attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The Double Loc attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.

Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm.

Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

TCX implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. TCX comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm.

Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.

Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm.

Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm.

Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.

Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.

Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.

Conical Retentor attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.

Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm.

Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

The provided text describes a 510(k) premarket notification for the "TOV Dental Implant System" and compares it to predicate devices to establish substantial equivalence. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device. As such, most of the requested fields cannot be populated from the provided document.

The document primarily focuses on demonstrating the substantial equivalence of the TOV Dental Implant System to existing predicate devices based on design, materials, indications for use, and mechanical performance (fatigue testing). It confirms biocompatibility (cytotoxicity, skin sensitization, irritation), sterilization, and packaging stability, which are standard tests for such devices, rather than clinical performance studies.

Here's an attempt to answer the questions based on the available information:

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

The document mentions "Sufficient run out load for their intended use" as the performance criteria for ISO 14801 Fatigue Testing for all devices (TOV Dental Implant System, OsseOne Dental Implant System, and Surgikor Dental Implant System). Specific numerical acceptance criteria or reported performance values (e.g., in Newtons or cycles) are not provided in this summary.

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

This information is not provided in the document. The document describes mechanical and biological safety testing, which typically use laboratory samples, not human patient test sets.

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)

This is not applicable as the device is a dental implant system (hardware), not an AI/ML diagnostic or image analysis tool. Ground truth in this context typically refers to objective measurements in material science or toxicology, not expert interpretations of clinical data.

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

Not applicable for a dental implant system.

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 for a dental implant system.

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

Not applicable for a dental implant system.

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

For the tests conducted (fatigue, cytotoxicity, etc.), the "ground truth" would be established by the physical and chemical properties of the materials, the mechanical limits defined by ISO standards, and the biological responses observed in laboratory tests (e.g., cell viability, immune response). There is no "expert consensus" in the clinical sense for this type of device's performance validation.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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IDCAM Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. IDCAM implants are intended for single or multiple unit restorations on splinted applications. They are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

The ID CAM Dental Implant is a tapered conical implant system with two designs. IDCAM M (with mini-threads), and IDCAM ST. IDCAM ST has large flat threads at the top and sharp threads at the bottom and comes in diameters of 3.7, 3.9, 4.2 and 5.2 mm. Lengths of 9.4, 11.4, and 14.4 mm are available. The IDCAM M has mini-threads at the top and with sharp threads below. It comes in 4.2, and 5.2 mm diameter with lengths of 8.5,9.4, 11.4, and 14.4mm. The bottom of both IDCAM designs is convex.

All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface.

ID CAM abutments for single unit restorations are all attached by Morse taper fit as well as a screw. Morse taper cone straight abutments come in 3.6 and 4.2mm diameter with gingival heights of 1.4, 3, and 5mm. Morse taper cone shouldered straight abutments come in 5.4mm diameter at the upper platform with a 3.6mm diameter at the platform and gingival heights of 1.3, 2.2, 3.2, and 5mm. Morse taper angled cone abutments come in 7°, 15°, and 23° angles in diameters of 3.6 and 4.2 and gingival heights of 1.4 (7° only) or 1.63 (15° and 23°), 3, and 5mm. Morse taper angled cones abutments with shoulder come in 7°, 15°, and 23° angles in a diameter of 5.4 at the upper platform with a 3.6mm diameter at platform bottom and gingival heights of 0.9, 3, and 5mm in 7°, and gingival heights of 0.9, 2.35, 3.30, and 5.03mm in 15°, and 23°.

PLAN abutments in 5.4mm diameter at shoulder top with a 3.6mm diameter at shoulder bottom and come in gingival heights of 1.5 and 3mm and there are straight, 15°, and 23° versions. Plan abutments can be used for single or multiple unit restorations but are not used for removable prostheses.

Straight IDUnit abutments, angled IDUnit abutments, IDLoc abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. IDLOC is 3.6mm diameter at platform and comes in gingival heights of 2.5, and 7.5 mm. Ball attachments are in 3.5 diameter and come in gingival heights of 1, 2.5, 4, or 6mm. Straight IDUnits are in 3.6mm diameter with 4.9mm diameter at top of shoulder and come in gingival heights of 1, 2.5, 4 or 6 mm. 17° angled IDUnits come in 3.6mm diameter with 4.9mm diameter at top of shoulder and in a gingival heights of 1.35,3.02 or 5 mm. 30° angled IDUnits come in 3.6mm diameter with a 4.9mm diameter at top of shoulder and in a gingival heights of 1,3.01 or 5 mm. Straight and angled IDUnit mounted dentures can only be removed by the dentures mounted on IDLoc or ball attachments can be removed by the patient.

Provisory abutments are temporary use abutments which allow placement of a temporary restoration. These come in 3.6mm diameter and varieties of nonrotational (4.8mm diameter at top of shoulder, gingival height of 1.5mm and post height of 7.5mm), nonrotational tall (4mm diameter at top of shoulder, gingival height of 1.5mm and post height of 12.5mm), rotational (gingival height of 1.5mm and post height of 7.5mm) and provisory IDUnit (4.9mm diameter at the base and a post height of 10.5mm).

Healing caps are temporary use abutments used during the healing phase which come in different gingival heights shapes in order to account for tissue thickness differences and space differences. Cylindrical shape healing caps come in diameters of 3.2mm with heights of 3.5 and 5mm, 4 & 5 mm with heights of 2, 4, 6, and 8mm. Conical profile healing caps come in 3.6mm diameter at the platform with a 6mm cone top diameter and 4mm gingival height, or a 3.6mm diameter at platform with a 6mm cone top diameter and gingival height of 6mm. There is also a healing cap for the IDUnit.

This document is a 510(k) Premarket Notification summary for the IDCAM Dental Implants. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria based on clinical outcomes or AI performance.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/device performance study are not applicable to this type of regulatory submission for a dental implant.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide a table of acceptance criteria with numerical performance data in the way you'd expect for an AI or diagnostic device assessing clinical outcomes (e.g., sensitivity, specificity).
Instead, it demonstrates substantial equivalence to predicate devices for a physical implant. The "acceptance criteria" here are more about meeting recognized standards and being comparable to legally marketed devices.

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical images. For mechanical testing (like ISO 14801), the sample sizes would be a small number of physical implant components tested in a lab, not patient data. These details are typically in a separate test report, not summarized in the 510(k) summary itself.
• Data Provenance: The data comes from in-vitro (lab-based) physical and chemical testing of the device components, not from clinical studies on patients. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context refers to the defined properties of the materials and the performance under standardized mechanical tests, not clinical diagnoses made by experts.

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

Not applicable, as this relates to expert review of clinical data, which was not the basis of this 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

Not applicable. This is a medical device (dental implant), not an AI diagnostic software. No human reader studies were conducted or required for this type of submission.

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

Not applicable. This is a physical device, not an algorithm.

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

The "ground truth" for the device's performance is established by:

• Adherence to recognized international standards (e.g., ISO 14801 for fatigue testing, ISO 10993-5 for cytotoxicity, ISO 11137 for sterilization).
• Material specifications (ASTM F136).
• Comparison to the established, legally marketed predicate device's characteristics and performance under these same standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model. There is no concept of a "training set" in this context.

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

Not applicable.

Summary of the Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" in this context is a series of engineering and biocompatibility tests designed to demonstrate that the IDCAM Dental Implants are substantially equivalent to a legally marketed predicate device (SpiralTech Dental Implant System Ultimate Conical K170372, and reference predicates Cortex K090709 and K163385).

• Objective: To show that the new device is as safe and effective as the predicate device, and does not raise new questions of safety or effectiveness.
• Methodology:
  • Indications for Use Comparison: The Indications for Use statement for IDCAM Dental Implants was compared directly to that of the predicate device and found to be "same."
  • Material Comparison: The device material (ASTM F136 Ti 6Al 4V ELI) was confirmed to be identical to the predicate device. Biocompatibility testing per ISO 10993-5 was performed.
  • Design Comparison: Detailed design specifications (diameters, lengths, connections, screw types, abutments, etc.) were compared. Minor differences in specific sizes were acknowledged but deemed not to change substantial equivalence given similar use, materials, and technology.
  • Performance Testing (In-Vitro):
    • Dynamic fatigue testing according to ISO 14801: This standard evaluates the endurance limit of endosseous dental implants under cyclic loading. The reported performance was that IDCAM implants "exhibited a run out limit equivalent to other implant systems," specifically comparable to the predicate.
    • Surface Modification Information: Provided per FDA Guidance Document for Endosseous Dental Implants and Abutments.
    • Sterilization Validation: Conducted per ISO 11137-1,-2,and -3 for implants and ISO 17665-2 and ANSI/AAMI ST79 for abutments.
    • Package Integrity Testing and Accelerated Aging: Per ISO 11607-1 and -2.
    • Endotoxin Testing: Per USP 161.
• Conclusion: Based on these comparisons and performance tests demonstrating equivalence in indications for use, materials, design, and fatigue performance, the FDA determined that the IDCAM Dental Implants are substantially equivalent to the predicate device.

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