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 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 and zirconia abutments are compatible with the Nobel Biocare's NobelActive Implants: NP 3.3mm, RP 4.3mm and 5.0 mm sizes

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™ Abutment for Nobel Biocare Active Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.3mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Nobel Biocare Active Implant for the 3.5mm, 4.3mm and 5.0mm 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) premarket notification for a dental abutment. The primary purpose of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish safety and effectiveness through clinical trials with detailed acceptance criteria and performance studies for a novel device.

Therefore, the document does not contain the kind of detailed information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes for test sets, expert ground truth establishment, or clinical study designs (like MRMC or standalone performance). The "study" proving the device meets acceptance criteria is fundamentally a demonstration of equivalence to the predicate, primarily through material and design specifications and intended use.

Here's an analysis based on the information provided, explaining why certain sections of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., specific force resistance values, wear rates, etc.). The "acceptance criteria" for this submission are fundamentally demonstrating that the Atlantis™ Abutment for Nobel Active Implant has the same intended use, material, and design characteristics as the predicate devices, and performs similarly in terms of its intended function as an endosseous dental implant abutment.
Reported Device Performance: No specific quantitative performance data (e.g., stress testing results, fatigue life in cycles) is reported in this summary. The performance is implied to be "substantially equivalent" to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Intended Use matches predicate	The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient, supporting single and multiple tooth prosthesis, in the mandible or maxilla. This aligns with the general intended use of endosseous dental implant abutments.
Material composition matches predicate or is well-established	Abutments and screws are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) and/or yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). These are standard, biocompatible materials used in dental implants.
Design principles and compatibility match predicate	The abutments are designed to be placed into the dental implant to provide support for a prosthetic restoration (cemented or screw-retained). They are compatible with Nobel Biocare's NobelActive Implants (NP 3.3mm, RP 4.3mm and 5.0 mm sizes). The design provides similar functionality to the predicate abutments.
Performance (e.g., strength, durability) is substantially equivalent to predicate	Not explicitly quantified or reported, but implied by the assessment of substantial equivalence in materials and design. The general note about highly angled abutments for anterior regions suggests consideration of strength relevant to different anatomical locations.

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

Sample Size: Not applicable in the context of this 510(k) summary. This document does not describe a clinical performance study with a "test set" of patients or images. Instead, it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices.
Data Provenance: Not applicable. There is no patient data (retrospective or prospective) described in this submission.

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

Not applicable. There is no "test set" requiring expert ground truth in this type of submission.

4. Adjudication method for the test set:

Not applicable. There is no patient-level or image-level test set that would require adjudication.

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 for tooth restoration, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a physical medical device (an abutment), not an algorithm or AI system.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices, based on their prior marketing clearance and use. The new device demonstrates conformance to established engineering specifications and biocompatibility standards rather than clinical ground truth from patient outcomes.

8. The sample size for the training set:

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

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

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

In summary: K093483 is a 510(k) premarket notification for a dental abutment. The "study" demonstrating that it meets "acceptance criteria" is the comprehensive technical and regulatory documentation showing its substantial equivalence to previously cleared predicate devices (K071370 and K072129) in terms of intended use, materials, and design. It is not a clinical trial with performance metrics typically associated with novel or AI-driven diagnostic devices.

Summary

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K093483

Pre-market Notification Page - 000009 - - - - - - - - - - - - - - -

DEC 22 2009

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 1.

Astra Tech Inc. 590 Lincoln Street Waltham, Massachusetts 02451 781-810-6462 Telephone Number: 781-810-6719 Fax Number: Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs

Name of Device 2.

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

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

Manufacturer	Device	510(k)Number
Nobel Biocare	Nobelactive Internal ConnectionImplant	K071370
Nobel Biocare	Nobelactive Zirconia Abutment	K072129

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Pre-market Notification Page - 000010 - - - - - - - - - - - - - - - - - -

Description of the Device 4.

న. Intended Use of the Device

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

The titanium and zirconia abutments are compatible with the Nobel Biocare's NobelActive Implants: NP 3.3mm, RP 4.3mm and 5.0 mm sizes

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Pre-market Notification Page - 000010a - - - - - - - - - - - - - -

6. Basis for Substantial Equivalence

The Atlantis™ Abutments for Nobel Biocare Active Implants are substantially equivalent in intended use, material, design and performance to the Nobel Biocare Nobelactive Internal Connection Implant System cleared under K071370 and the Nobel Biocare Nobelactive Zirconia Abutment cleared under K072129.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

EC 2 2 2 2009

Re: K093483

Trade/Device Name: Atlantis™ Abutment for Nobel Biocare Active Implant Regulation Number: 21 CFR 872.3630 Regulatory Class: II Product Code: NHA Dated: July 27, 2009 Received: November 9, 2009

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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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)

Device Name: Atlantis TM Abutment for Nobel Biocare Active Implant

Indication for Use:

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 and zirconia abutments are compatible with the Nobel Biocare's NobelActive 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.

RSBetz DMS for Dr. K.P. Mulry (Acting)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K093483

Prescription Use
(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)

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.)