The Atlantis Abutment is intended for use as an accessory to 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 maxillated prosthesis can be cement 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: Nobel Biocare Replace Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage.

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 restorations.

The Atlantis™ Abutments for Nobel Replace Interface and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Nobel Replace® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants.

AI/ML Overview

The provided text is a 510(k) summary for the Atlantis™ Abutment for Nobel Replace Interface. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and performance metrics in the way a clinical trial or software validation study would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set sample size, how training set ground truth was established) are not applicable (N/A) because this submission format does not require such detailed efficacy or performance study data.

The acceptance criteria for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device. This is primarily achieved through comparisons of intended use, material, design, and performance, rather than through specific quantitative metrics of a clinical study.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description of Acceptance Criteria (Implied by 510(k))	Reported Device Performance/Comparison (from text)
Intended Use	Must be substantially equivalent in intended use to predicate device(s).	"substantially equivalent in intended use... to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace Tillnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively." Intended use described as: accessory to an endosseous implant to support a prosthetic device in partially or completely edentulous patients, supporting single/multiple tooth prosthesis, cement-retained.
Materials	Must use materials substantially equivalent to or accepted for predicate device(s).	"made from Titanium grade Ti-6Al-4V ELI (Meets ASTM Standard F-136)." This implies equivalence or compliance with recognized standards.
Design	Must be substantially equivalent in design to predicate device(s).	"substantially equivalent in... design... to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace Tillnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively." Described as placed over implant shoulder, mounted with a screw, compatible with specific Nobel Replace implant types.
Performance	Must demonstrate substantially equivalent performance to predicate device(s).	"substantially equivalent in... performance... to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace Tillnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively." (No specific quantifiable performance data for this device is provided in this summary, but typically mechanical testing data would be submitted separately for such devices to demonstrate equivalency in strength or fatigue.)
Compatibility	Must be compatible with specified implant systems.	"compatible with Nobel Replace® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants."
Safety Warnings/Limitations	Acknowledge and communicate known limitations or precautions.	"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 not intended for the posterior region due to limited strength of the implant."

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

N/A. This document does not describe a clinical performance study with a distinct "test set" of patients or samples in the way an AI/software or clinical trial report would. The "study" here is a demonstration of substantial equivalence to predicate devices, likely through engineering bench testing and comparison, not patient data analysis.

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)

N/A. Ground truth is not established in the context of this 510(k) summary. The evaluation relies on established device specifications, materials standards (ASTM), and comparison to existing cleared devices.

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

N/A. Not applicable as there is no human adjudication of a "test set" in this type of 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

N/A. This device is a dental implant abutment, not an AI or imaging diagnostic device. Therefore, MRMC studies are not relevant.

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

N/A. This device is not an algorithm.

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

N/A. For this type of device and submission, "ground truth" as it relates to clinical outcomes or diagnostic accuracy is not the primary focus. Instead, the "truth" against which the device is measured is its adherence to material specifications, design compatibility, and established safety/performance characteristics demonstrated by predicate devices, typically through bench testing and engineering analysis (though specific results are not detailed in this summary).

8. The sample size for the training set

N/A. There is no "training set" as this is not an AI or machine learning device.

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

N/A. There is no "training set" as this is not an AI or machine learning device.

Summary

{0}------------------------------------------------

K053654

Pre-market Notification Page - 00009 ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..

JUL 3 1 2006

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.

Applicant's Name and Address 。

华尔斯

Atlantis Components Inc. 25 First Street Cambridge, Massachusetts 02141 617-661-9799 Telephone Number: Fax Number: 617-661-9063 Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs

2 Name of Device

Trade Name:	Atlantis TM Abutment for Nobel Replace Interface
Common Name:	Endosseous dental implant abutment
Classification Name:	Endosseous dental implant abutment21 CFR 872.3630 Product code NHA

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

Manufacturer	Device	510(k)Number
Atlantis ComponentsInc.	Atlantis Abutment and AbutmentScrew	K981858 K023113
Nobel Biocare	Replace TiUnite	K020646
Nobel Biocare	Replace Ha Coated Implant

ત્વે . Description of the Device

{1}------------------------------------------------

Pre-market Page - 00010 ******************************************************************************************************************************************************************************

Description of the Device (continued) 4.

Intended Use of the Device ur,

The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic reconstruction. The Atlantis Abutment is intended for use as an accessory to 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 coment retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

Please note: 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 not intended for the posterior region due to limited strength of the implant.

Basis for Substantial Equivalence 6.

The Atlantism Abutments for Nobel Replace Interface are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace Tillnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2006

Atlantis Components, Incorporated C/O Ms. Betsy A. Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terracc Skokie. Illinois 60076

Re: K053654

Trade/Device Name: Atlantis™ Abutment for Nobel Replace Interface Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 13, 2006 Received: July 17, 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 vour device in the Federal Register

{3}------------------------------------------------

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 on user not of the Act or any Federal statutes and regulations administered by other Federal regencies. 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); good manufacturing rogettice 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your desice to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.

Sincerely vours.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Pre-market Notification Page - 000227

Indications for Use

510(k) Number (if Known) Kos 365 365 4

Device Name: Atlantis TM Abutment for Nobel Replace Interface

Indication for Use:

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.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Fronk Seitz, DDS for D. Duncan Kenner
(yn. OH)

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.)