OsseoSpeed™ Angled Abutment EV is intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

The AtlantisTM 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 prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

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

Atlantis™ Abutment and Atlantis™ Crown Abutment are compatible with Ø5.4 Astra Tech Implant System EV.

Device Description

OsseoSpeed Angled Abutment EV is designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. It is provided in three platform diameters (3,6, 4,2 and 4.8 mm) and two angles (20° and 30°). It is intended to fit Astra Tech implants of corresponding diameters cleared under K111287 and K120414. All abutments with a 20°angle are provided in two gingival heights (1.0 and 2.0 mm) with an indexed interface. All abutments with a 30°angle have a non-indexed interface and are provided in two gingival heights (1.0 and 3.0 mm).

OsseoSpeed Angled Abutment EV is not compatible with Astra Tech 3.0 mm diameter implants.

Atlantis Abutment in Zirconia for OsseoSpeed EV is a custom abutment for prosthesis attachment. Atlantis Crown Abutment in Zirconia for OsseoSpeed EV is fabricated as a custom single-tooth final restoration and is shaped in the design of the final prosthesis onto which porcelain is added. Both Atlantis abutments are provided in a platform diameter of 5,4 mm.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (dental abutments) and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way typically required for AI/ML-based diagnostic devices.

The document discusses the substantial equivalence of the new device to existing predicate devices based on its intended use, design principles, materials, and manufacturing processes. It briefly mentions "Testing of OsseoSpeed™ Angled Abutment EV according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants, was performed and the results show that OsseoSpeed™ Angled Abutment EV has sufficient mechanical strength for the intended clinical application and demonstrate that it is substantially equivalent to the listed predicate devices."

However, this is a mechanical fatigue test, not a clinical performance study with expert ground truth, multi-reader multi-case analysis, or standalone algorithm performance, as would be relevant for an AI/ML device. Therefore, most of the requested fields cannot be filled from the provided text.

Here is an attempt to address the request based on the available information:

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

Acceptance Criteria	Reported Device Performance
Mechanical Strength (ISO 14801 Dynamic Fatigue Test for Endosseous Dental Implants)	"sufficient mechanical strength for the intended clinical application" and "demonstrate that it is substantially equivalent to the listed predicate devices."

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

Sample Size: Not specified for the ISO 14801 test.
Data Provenance: Not specified, but likely from laboratory testing (in vitro) based on the test type.

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. The ground truth for a mechanical fatigue test is typically defined by the physical properties and performance characteristics measured according to the standard, not by expert interpretation.

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

Not applicable. This concept pertains to human review of diagnostic results, not mechanical testing.

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

No. This document does not mention an MRMC study or AI assistance.

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

No. This document does not describe an algorithm or AI.

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

For the mechanical test, the ground truth is based on the physical properties and performance characteristics as defined and measured by the ISO 14801 standard.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary

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510(k) Summary

JAN 2 3 2013

Astra Tech AB OsseoSpeed™ Angled Abutment EV K121810

January 23, 2013

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Astra Tech AB Aminogatan 1, P.O. Box 14 Mölndal, Sweden SE-431-21 +46 31 776 30 00 Telephone: +46 31 776 30 10 Fax:

Official Contact:

Representative/Consultant:

Christina Lewing Head of Regulatory Affairs

Linda K. Schulz, BSDH, RDH Kevin A. Thomas, PhD PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 email: lschulz@paxmed.com kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name: Classification Regulation: Product Code: Classification Panel: Reviewing Branch:

OsseoSpeed™ Angled Abutment EV Dental implant abutment Endosseous dental implant abutment Class II, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch

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INTENDED USE

Atlantis™ Abutment and Atlantis™ Crown Abutment are compatible with Ø5.4 Astra Tech Implant System EV.

DEVICE DESCRIPTION

OsseoSpeed Angled Abutment EV is not compatible with Astra Tech 3.0 mm diameter implants.

EQUIVALENCE TO MARKETED DEVICE

OsseoSpeed™ Angled Abutment EV is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

Astra Tech AB - K111287 Astra Tech, Inc. - K112138 Astra Tech, Inc. - K110356

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The purpose of this submission is to expand the OsseoSpeed Plus implant system to include three new components, the OsseoSpeed Angled Abutment EV, the Atlantis Abutment in Zirconia for OsseoSpeed EV, and Atlantis Crown Abutment in Zirconia for OsseoSpeed EV.

OsseoSpeed Angled Abutment EV is provided in two angles (20° and 30°). Platform sizes correspond to OsseoSpeed Plus implant diameters cleared in K111287. OsseoSpeed Angled Abutment EV is indicated for multi-unit restorations as are the predicate devices.

The original Atlantis Abutment in Zirconia for OsseoSpeed Plus was cleared in K112138 and the Atlantis Crown Abutment in Zirconia for OsseoSpeed in K110356. The interface remains the same as in K112138. A new size of Ø5.4 mm has been added for both designs.

Testing of OsseoSpeed™ Angled Abutment EV according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants, was performed and the results show that OsseoSpeed™ Angled Abutment EV has sufficient mechanical strength for the intended clinical application and demonstrate that it is substantially equivalent to the listed predicate devices.

Overall, OsseoSpeed Angled Abutment EV has the following similarities to the predicate devices:

has the same intended use,
uses the same operating principle, . ●
. incorporates the same basic design,
. incorporates the same or very similar materials, and
has similar packaging and is sterilized using the same materials and processes .

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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 features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular fashion around the eagle.

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

January 23, 2013

Astra Tech AB C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130

Re: K121810

Trade/Device Name: OsseoSpeed 110 Angled Abutment EV Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 2, 2013 Received: January 3, 2013

Dear Ms. Schulz:

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. Schulz

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/ucm115809.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,

Kwame O. Ulmer

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

Radiological Health

Enclosure

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Indications for Use

510(k) Number: K)21810

OsseoSpeed™ Angled Abutment EV Device Name:

Indications for Use:

The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic I he Atiantis - I Duanon in intelly edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to The Attamily - Crown Fre that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

Atlantis™ Abutment and Atlantis™ Crown Abutment are compatible with Ø5.4 Astra Tech Implant System EV.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Page 1 of 1

Sheena A. Green 2013.01.23 16:10:12 -05/00

Division Sign Off) (Division Sign-Off)
Division of Anesthestology, General Hospital Division of Anton, Dental Devices

510(k) Number

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.)