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Atlantis Abutment & Atlantis Abutment Milling
The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant.

Atlantis Crown Abutment
The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant.

Atlantis Conus Abutment
The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment-retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant.

Atlantis Healing Abutment
The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.

Implant Manufacturer: Institut Straumann
Implant System: Straumann BLX
Implant Diameter (in mm): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5
Abutment Platform Diameter (in mm): 2.69

Implant System: Neodent GM
Implant Diameter (in mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0
Abutment Platform Diameter (in mm): 3.0

The Atlantis® Abutments in Titanium are patient-specific dental abutments that are intended for attachment to dental implants in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The design of the Atlantis® Abutments in Titanium is derived from patient dental models and is completed by Dentsply Sirona using computer-assisted design (CAD) technology according to the clinician's prescription. The final CAD design of the Atlantis® Abutment in Titanium is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. Design and fabrication of the Atlantis® Abutment in Titanium is completed in internal Dentsply Sirona manufacturing facilities.

Alternatively, the CAD design, according to the clinician's prescription, can be performed by a laboratory or clinician in an FDA cleared abutment design software (3Shape Abutment Designer Software, K151455) within the design envelope of the Atlantis® Abutments which is codified in the validated and locked design library of the cleared software. Fabrication of the Atlantis® Abutment is then completed in internal Dentsply Sirona manufacturing facilities.

The Atlantis® Abutment in Titanium serves as a connection of the prosthetic construction and the endosseous implant. The lower part of the abutment is designed to fit with the specific implant geometry it is compatible, and the upper part design is according to the patient's specific anatomy. The Atlantis® Abutment, including the Conus and Healing abutments further described below, are available in Titanium or Gold-shaded (titanium nitride layer applied using PVD (Physical Vapor Deposition)) Titanium. The Crown Abutment which is another Atlantis® Abutment in Titanium, is only available in Titanium.

The Atlantis® Abutment design envelope became the basis for the other more specific designs that make up the Atlantis® Abutments in Titanium. The Atlantis® Abutment is intended for use with an endosseous implant and for single tooth restoration.

The Atlantis® Crown Abutment in Titanium is also a custom fabricated abutment using the same internal CAD/CAM technology. The Atlantis® Crown Abutment in Titanium incorporates a design that is a combination of an abutment and an anatomically accurate crown to constitute the final finished device. It functions as a substructure that also serves as the final abutment, in a partially or completely edentulous patient.

The Atlantis® Conus Abutment supports a removable prosthesis (bridges and overdentures) which is retained by friction fit to the abutment. The abutment connects to the prosthesis via caps embedded in the prosthesis.

The Atlantis® Healing Abutment is used with the compatible implants for temporary use during soft tissue healing after one-stage and two-stage surgeries. It is designed based on the planned final Atlantis® Abutment or Atlantis® Crown Abutment, using the same emergence profile as those abutments to achieve an aesthetic outcome during the soft tissue healing phase.

The proposed Atlantis® Abutments in Titanium for Straumann BLX Implant are compatible with the Straumann BLX Implants. This implant system is available in diameters of 3.5, 3.75, 4.0, 4.5 5.0, 5.5 and 6.5 mm and in lengths of 8, 10, 12, 14, 16, and 18 mm all with identical mating geometry.

The proposed Atlantis® Abutments in Titanium for Neodent GM Implant are compatible with the Neodent GM Implants. This implant system is available in diameters of 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, and 7.0 mm and in lengths of 7, 8, 9, 10, 11, 11.5, 13, 15, 16, 17 and 18 mm, all with identical mating geometry.

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The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• · Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
• · Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
• · Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.
  • Immediate and early loading for all indications, except in single tooth situations on implant shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain, and immediate loading may not be appropriate.
  · The intended use for PrimeTaper EV Ø3.0 is limited to replacement of maxillary lateral incisors and mandibular incisors.

DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

MultiBase Abutments EV:
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

The proposed (A) PrimeTaper EV Dental Implant Ø3.0 is a root form endosseous implant which is intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. It represents an additional extra small implant diameter implant) to reference device PrimeTaper EV Dental Implants (K210610).

The proposed (A) PrimeTaper EV Dental Implant Ø3.0 has the identical implant-abutment connection geometry as the predicate (A) Astra Tech EV Implant (K120414), and is therefore compatible with the reference device Astra Tech EV Abutments (K120414) with 3.0 mm diameter of the Astra Tech Implant System EV (K120414).

The proposed (B) DS Implant abutments with EV connection XS include the following abutments and accessories:

• TiDesign EV (XS) ●
• MultiBase Abutment EV (XS) ●
• . TempAbutment EV (XS)
• Healing Abutment EV (XS) ●
• HealDesign EV (XS) ●
• Cover Screw EV (XS)
• Abutment Screw EV (XS) ●

The proposed (B) DS Implants abutments with EV connection XS are used in conjunction with an endosseous dental implant with EV connection to aid in prosthetic rehabilitation in fully edentulous or partially edentulous maxillary and/or mandibular arches. They are prosthetic abutments compatible with the proposed (A) PrimeTaper EV Dental Implant Ø3.0 and represent an additional extra small abutment-implant diameter (XS, 3 mm diameter) to the Predicate (B) DS Implants abutments with EV Connection in sizes S (small), M (medium) and L (large) (K213449).

The proposed (B) abutments have the identical implant-abutment connection geometry as the reference device Astra Tech EV Abutments (K120414) and are therefore compatible with the predicate (A) Astra Tech EV Implants (K120414) with 3.0 mm diameter.

The proposed (A) PrimeTaper EV Dental Implant Ø3.0 and proposed (B) DS Implants abutments with EV connection XS are single-use devices and are provided sterile by electron-beam irradiation except for TiDesign EV (XS). TempAbutment EV (XS) and Abutment Screw (XS), which are provided non-sterile. Devices provided as non-sterilized by the end user via steam sterilization.

The document provided is a 510(k) summary for Dentsply Sirona's PrimeTaper EV Dental Implants Ø3.0 and DS Implants abutments with EV connection (XS). It describes the devices, their intended use, and substantial equivalence to predicate and reference devices based on non-clinical performance data and published literature.

Here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner with specific thresholds. Instead, it relies on demonstrating that the proposed devices (PrimeTaper EV Dental Implants Ø3.0 and DS Implants abutments with EV connection XS) are substantially equivalent to legally marketed predicate devices. The performance is assessed by confirming that the proposed devices satisfactorily meet the requirements of non-clinical bench testing and aligning with published clinical data on similar devices.

However, based on the non-clinical testing performed, we can infer performance criteria against established standards:

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

• Non-clinical Testing (Bench Tests): The document refers to "worst-case implant-abutment combination" for fatigue testing but does not specify the exact number of samples tested for each non-clinical performance test (e.g., fatigue, biocompatibility, sterilization validation, MRI). It is implied that sufficient samples were tested to meet the requirements of the respective ISO and ASTM standards.
• Clinical Literature:
  • Sample Size: 200 narrow diameter implants (OsseoSpeed 3.0 mm, Astra Tech Implant System (K080396)) were evaluated. These implants were placed in "over 160 patients."
  • Data Provenance: The data is from "six peer-reviewed scientific publications" presenting "1 to 5 years of clinical follow-up data from four (4) different clinical trials." The country of origin is not specified but it relates to published peer-reviewed scientific literature. The studies were prospectively followed up.

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 section is not applicable to this submission. The "ground truth" in this context is established through compliance with recognized international standards (ISO, ASTM) for non-clinical testing and clinical outcomes reported in peer-reviewed literature, rather than expert adjudication of a test set in the way one might see for an AI algorithm.

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

Not applicable. This is not an AI/imaging device where expert adjudication for ground truth establishment is typically performed.

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 dental implants and abutments, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This is not an AI/algorithm-based device.

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

• Non-clinical Testing: The "ground truth" for non-clinical performance (sterilization, biocompatibility, fatigue, MRI safety, pyrogenicity, packaging) is defined by established international standards (ISO, ASTM) and FDA guidance documents. The device's performance is measured against these technical standards.
• Clinical Performance (via literature): The "ground truth" is based on outcomes data (survival rates, marginal bone maintenance) reported in peer-reviewed clinical literature.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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