The Atlantis Abutment is 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 prosthesis can be cement or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:

The titanium abutments are compatible with the Dentsply 3.0mm, 3.8mm, 4.5mm and 5.5mm XiVE® S Plus Implants.

The titanium and zirconia abutments are compatible with the Dentsply 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm Frialit® Plus Implants.

The zirconia abutments are compatible with Dentsply 3.4mm, 4.5mm and 5.5mm XiVE® S Plus Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Device Description

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Dentsply Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.0mm, 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the Atlantis™ Abutment for Dentsply Implant for the 3.4mm, 3.8mm, 5.5mm and 6.5mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y -TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

AI/ML Overview

The provided text is a 510(k) summary for the Atlantis™ Abutment for Dentsply Implant. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of performance metrics like sensitivity, specificity, accuracy, or reader studies for AI/medical imaging devices.

The document primarily focuses on establishing substantial equivalence based on material, design, and intended use to previously cleared devices. It does not present a clinical performance study with defined acceptance criteria and reported device performance in the way requested.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a breakdown based on what can be inferred or determined to be absent from the document:

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

Not applicable / Not provided. The document establishes substantial equivalence based on materials, design, and intended use, not on specific performance metrics with acceptance criteria like sensitivity, specificity, etc.

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

Not applicable / Not provided. No specific test set data is mentioned for performance evaluation.

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 / Not provided. No ground truth establishment is described for a performance test.

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

Not applicable / Not provided. No adjudication method is described.

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 / Not provided. This device is a dental abutment, not an AI or imaging device that would typically undergo MRMC studies.

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

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

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

Not applicable / Not provided. No performance-related ground truth is discussed.

8. The sample size for the training set

Not applicable / Not provided. This is not an AI/machine learning device that uses training sets.

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

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

Summary of what the document does provide:

The document focuses on demonstrating substantial equivalence to predicate devices by comparing:

Intended Use: The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla, with cement or screw-retained options. This aligns with the predicate devices.
Materials: The abutments are made from Titanium grade Ti-6A1-4V ELI (ASTM Standard F-136) and yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (ISO Standards 6072 & 13356). These materials are commonly used in dental implants and are present in equivalent forms in the predicate devices.
Design: The device functions as an abutment placed into a dental implant to support a prosthetic restoration. Compatibility with specific Dentsply implant systems is detailed. The design is considered substantially equivalent to the predicate devices.
Performance (as implied by equivalence studies, not specific metrics): The document implies that because the materials, design, and intended use are substantially equivalent to legally marketed predicate devices, its performance is also considered equivalent. This typically involves non-clinical bench testing (e.g., mechanical strength, fatigue, biocompatibility) rather than clinical performance metrics in the context of this type of device. While the 510(k) summary doesn't detail these tests, such data would typically be part of the full 510(k) submission to demonstrate the performance equivalence to the predicate.

Summary

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K093780

Attachment #1

VII. SECTION 10 - 510(K) SUMMARY

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

Date of Summary preparation: December 9, 2009

1. Applicant's Name and_Address

Astra Tech Inc.

590 Lincoln Street

Waltham, Massachusetts 02451

Telephone Number: 781-810-6462

Fax Number: 781-810-6719

Contact Person:

Manager of Quality and Regulatory Affairs

2. Name of Device

Trade Name:	Atlantis™ Abutment for Dentsply Implant
Common Name:	Endosseous dental implant abutment
Classification Name:	Endosseous dental implant abutment
	21 CFR 872.3630 Product code NHA

Franklin Uyleman

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Legally Marketed Device to which Equivalence is claimed (Predicate Device) 3.

Manufacturer	Device	510(k)Number
Dentsply International,Inc.	Frialit Plus, XIVE ® S Plus DentalImplant System	K073075
Atlantis ComponentsInc. (currently AstraTech)	Atlantis Abutment in Zirconia	K052070

4. Description of the Device

న. Intended Use of the Device

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5. Intended Use of Device (continued):

This device is compatible with the following manufacturers' implant systems:

The titanium abutments are compatible with the Dentsply 3.0mm, 3.8mm, 4.5mm and 5.5mm XiVE® S Plus Implants.

The titanium and zirconia abutments are compatible with the Dentsply 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm Frialit® Plus Implants.

The zirconia abutments are compatible with Dentsply 3.8mm, 4.5mm and 5.5mm XiVE® S Plus Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Basis for Substantial Equivalence Q.

The Atlantis™ Abutments for Dentsply Implants are substantially equivalent in intended use, material, design and performance to the Dentsply Frialit Plus, XIVE S Plus Dental Implant System cleared under K073075 and the Atlantis Components Inc. (currently, Astra Tech) Zirconia Abutment cleared under K052070.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 1 $ 2010

Astra Tech, Incorporated C/O Ms. Betsy A Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076

Re: K093780

Trade/Device Name: Atlantis™ Abutment for Dentsply Implant Regulation Number: 21CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 29, 2010 Received: March 30, 2010

Dear Ms. Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Brown

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1 | 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pre-market Notification Page - 000227

Indications for Use

510(k) Number (if Known)_109 3780

Device Name: Atlantis TM Abutment for Dentsply Implant

Indication for Use:

This device is compatible with the following manufacturers' implant systems:

The titanium abutments are compatible with the Dentsply 3.0mm, 3.8mm, 4.5mm and 5.5mm XiVE® S Plus Implants.

The titanium and zirconia abutments are compatible with the Dentsply 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm Frialit@ Plus Implants.

The zirconia abutments are compatible with Dentsply 3.4mm, 4.5mm and 5.5mm XiVE® S Plus Implants.

Prescription Use X (Part 21 CFR 801 SubpartD)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Asetz DDS for	Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology General Hospital

lestology, General Hospital Infection Control, Dental Devices

510(k) Number: K093780

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)