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: Astra Tech Systems OsseoSpeed™ Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters. 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. Also, 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 in Zirconia for Astra Implants is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and 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 the Astra Tech OsseoSpeed™ implants 3.5 mm, 4.0 mm, 4.5 mm and 5.0 mm diameters.

AI/ML Overview

This 510(k) premarket notification for the Atlantis™ Abutment in Zirconia for Astra Implants does not include a study proving device performance against acceptance criteria in the way typically seen for diagnostic or AI-driven devices.

Instead, this submission is a claim of substantial equivalence to previously cleared predicate devices based on material, design, and intended use. The "acceptance criteria" here relate more to meeting established standards for biocompatibility and mechanical properties rather than performance in a clinical or diagnostic setting.

Here's an breakdown based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Device Performance (Based on provided text)

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (as stated)
Biocompatibility: Device materials meet relevant ISO Standards.	Made of yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) meeting ISO Standards 6972 & 13356. Abutment screws made from titanium grade Ti-6A1-V ELI meeting ASTM Standard F-136.
Material/Design Equivalence: Material and design are similar to predicate devices.	"Substantially equivalent in intended use, material, design and performance to the Atlantis Abutments for Astra Implants cleared under K070833 and for Astra Tech Systems implants cleared under K053384 and K024111."
Intended Use Equivalence: Intended use matches predicate devices.	Intended use (support for prosthetic reconstruction, single/multiple tooth prosthesis, mandible/maxilla, cement-retained, secure abutment to implant) is stated to be substantially equivalent to predicate devices. Specific compatibility with Astra Tech OsseoSpeed™ implants (3.5 mm, 4.0 mm, 4.5 mm and 5.0 mm diameters).
Mechanical Performance (Implied by material standards and equivalence claim): Mechanical properties (e.g., strength, durability) are comparable to predicate devices and suitable for dental implant abutment.	Not explicitly tested or reported in this document as a standalone study result. Relied upon the equivalence claim and compliance with material standards for Y-TZP and Ti-6A1-V ELI. A specific caution is given for highly angled abutments on smaller diameter implants regarding limited strength.

Further Information Based on the Document:

Sample size used for the test set and the data provenance:
- N/A. No "test set" in the context of performance data (e.g., clinical outcomes, diagnostic accuracy) is described. The submission relies on a comparison to predicate devices, material standards, and intended use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No ground truth establishment by experts for a test set is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No adjudication method for a test set is described.
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:
- No. This device is a dental implant abutment, not a diagnostic imaging device or an AI-driven tool for human readers. Therefore, an MRMC study is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device (dental abutment), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this type of 510(k) submission, the "ground truth" is largely established by adherence to recognized material standards (ISO, ASTM) and the established performance/safety profile of the predicate devices. There is no "ground truth" in the sense of clinical outcomes or pathology data specifically collected for this submission to prove its performance.
The sample size for the training set:
- N/A. This is a physical medical device, not a machine learning model. There is no training set mentioned or implied.
How the ground truth for the training set was established:
- N/A. As above, no training set is relevant here.

Summary of the Study/Evaluation described in the document:

The document describes a substantial equivalence claim rather than a "study" in the traditional sense of a clinical trial or performance evaluation against specific metrics. The "study" implicitly performed by the manufacturer, and reviewed by the FDA, involved:

Comparison to Predicate Devices: The Atlantis™ Abutment in Zirconia for Astra Implants was compared to three predicate devices (K070833, K053384, K024111) to demonstrate equivalence in intended use, material, design, and performance. This is the primary method of evaluation for this 510(k)
Material Characterization: The biocompatibility and composition of the materials (Y-TZP and Ti-6A1-V ELI) were likely verified against established international standards (ISO 6972, ISO 13356, ASTM F-136).
Design Specifications: The design would have been reviewed to ensure it met specifications compatible with the Astra Tech OsseoSpeed™ implants and to verify that any design changes from predicate devices did not raise new questions of safety or effectiveness. This would include considerations for angled abutments and implant diameters.

The FDA's review and clearance signify their agreement that the provided information supports the claim of substantial equivalence, meaning the device is as safe and effective as the legally marketed predicate devices.

Summary

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K071946

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

OCT 5 * 2007

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.

1. Applicant's Name and Address

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

2. Name of Device

Trade Name:	Atlantis™ Abutment in Zirconia for Astra Implant
Common Name:	Endosseous dental implant abutment
Classification Name:	Endosseous dental implant abutment
21 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 for Astra Implant	K070833
Astra Tech ImplantSystems	Fixture MicroThreadTM OsseoSpeedTM	K053384
Astra Tech ImplantsSystems	Astra Tech Implants-Dental SystemFixture OsseoSpeedAstra Tech Implants- Dental SystemsFixture MicroMarco	K024111

4. Description of the Device

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

4. Description of the Device (continued)

The Atlantis™ Abutments in Zirconia for Astra Implants is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and 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 the Astra Tech OsseoSpeed™ implants 3.5 mm, 4.0 mm, 4.5 mm and 5.0 mm diameters.

5. Intended Use of the Device

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 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.

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 are not intended for the posterior region due to the limited strength of the implant fixture.

6. Basis for Substantial Equivalence

The Atlantis™ Abutments in Zirconia for Astra Implant are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments for Astra Implants cleared under K070833 and for Astra Tech Systems implants cleared under K053384 and K024111.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 5 ° 2007

Re: K071946

Trade/Device Name: Atlantis™ Abutment in Zirconia for Astra Implants Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 20, 2007 Received: September 24, 2007

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 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 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); 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.

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 device 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/cdrh/industry/support/index.html.

Sincerely vours.

Signature

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

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Pre-market Notification Page - 000227

Indications for Use

510(k) Number (if Known) KD7 1946

Device Name: Atlantis TM Abutment in Zirconia for Astra Implants

Indication for Use:

This device is compatible with the following manufacturers' implant systems: Astra Tech Systems OsseoSpeed™ Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters.

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.

Also, 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.

Prescription Use(Part 21 CFR 801 SubpartD)	X	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH (Office of Device Evaluation (ODE))

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:	K071946
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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.)