Implants: The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: · replacing missing teeth in single or multiple unit applications in the mandible or maxilla. - · immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge - · especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective - · immediate and early loading for all indications - · together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate - · only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components Abutments ASTRA TECH Implant System™ - OsseoSpeed™ EV abutments are intended to be used in conjunction with ASTRA TECH Implant System™ - OsseoSpeed™ EV in fully edentulous or partially edentulous maxillary and/or mandibular arches. 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 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 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. The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant. ATLANTIS™ Abutment, ATLANTIS™ Crown Abutment and ATLANTIS™ Conus Abutment are compatible with ASTRA TECH Implant System Profile EV.

Device Description

The purpose of this submission is to expand the current OsseoSpeed EV Implant System (previously named OsseoSpeed Plus) to include the OsseoSpeed Profile EV implants. The OsseoSpeed EV Implant line is a part of the ASTRA TECH Implant System. The coronal contour of the OsseoSpeed Profile EV implant is designed to follow the anatomical contour of the bone and facilitate a more esthetic restoration. Implants are available in a straight (cylindrical) design or with a taper at the implant neck. Each design is provided in two diameters (4.2 and 4.8 mm) and six lengths (8, 9, 11, 13, 15, and 17 mm). Abutments are provided in titanium allov and zirconia materials. Abutments have platform diameters of 3.0, 4.2, and 4.8 mm, prosthetic diameters from 3.3 to 7.0 mm, and gingival heights ranging from 2.0 to 6.5 mm. Abutments are provided straight and with up to 30° of angulation.

AI/ML Overview

The OsseoSpeed™ Profile EV is a dental implant system. The provided 510(k) summary (K130999) focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel technology or algorithm. Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC, standalone performance, training set details) are not applicable or cannot be extracted from this document, as they pertain to clinical or AI algorithm performance studies, which are not detailed here.

However, the document does describe the performance testing conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Compliance)	Reported Device Performance
Static and dynamic compression-bending testing according to ISO 14801	Data included in the submission demonstrates substantial equivalence to the listed predicate devices.

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

The document does not specify the sample size for the mechanical testing or data provenance (e.g., country of origin, retrospective/prospective). It only states that "Performance testing is provided."

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

Not applicable. The ground truth for this type of device (dental implant mechanical performance) is established through standardized engineering tests rather than expert interpretation of data.

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

Not applicable. This concept is relevant to clinical studies involving expert consensus on diagnoses or outcomes, not to mechanical testing for device equivalence.

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 device is a dental implant system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical dental implant, not a software algorithm.

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

The "ground truth" in this context is the performance of the predicate devices under ISO 14801 testing conditions. The subject device's performance is compared against these established benchmarks.

8. The sample size for the training set

Not applicable. This document describes a medical device seeking substantial equivalence based on mechanical performance and design principles, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device submission.

Summary

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510(k) Summary K130999

510(k) Summary DENTSPLY Implants OsseoSpeed™ Profile EV K130999

September 23, 2013

OCT 2 5 2013

ADMINISTRATIVE INFORMATION

Manufacturer Name	DENTSPLY Implants
	Aminogatan 1, P.O. Box 14
	Mölndal, Sweden SE-431-21
Telephone:	+46 31 776 30 00
Fax:	+46 31 776 30 10
Official Contact	Christina Lewing
	Head of Regulatory Affairs
Representative/Consultant	Linda K. Schulz, BSDH, RDH
	Kevin A. Thomas, PhD
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	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 Regulations

Product Code Classification Panel Reviewing Branch

OsseoSpeed™ Profile EV Dental implant and abutment

Endosseous dental implant Class II, 21 CFR 872.3640

DZE, NHA Dental Products Panel Dental Devices Branch

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INTENDED USE

Implants:

The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: · replacing missing teeth in single or multiple unit applications in the mandible or maxilla.

· immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge
· especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective
· immediate and early loading for all indications
· together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate
· only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components

Abutments

ASTRA TECH Implant System™ - OsseoSpeed™ EV abutments are intended to be used in conjunction with ASTRA TECH Implant System™ - OsseoSpeed™ EV in fully edentulous or partially edentulous maxillary and/or mandibular arches.

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 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 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.

The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant.

ATLANTIS™ Abutment, ATLANTIS™ Crown Abutment and ATLANTIS™ Conus Abutment are compatible with ASTRA TECH Implant System Profile EV.

DEVICE DESCRIPTION

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Implants are available in a straight (cylindrical) design or with a taper at the implant neck. Each design is provided in two diameters (4.2 and 4.8 mm) and six lengths (8, 9, 11, 13, 15, and 17 mm).

Abutments are provided in titanium allov and zirconia materials. Abutments have platform diameters of 3.0, 4.2, and 4.8 mm, prosthetic diameters from 3.3 to 7.0 mm, and gingival heights ranging from 2.0 to 6.5 mm. Abutments are provided straight and with up to 30° of angulation.

EQUIVALENCE TO MARKETED DEVICE

DENTSPLY Implants submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices OsseoSpeed™ Profile EV is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

Astra Tech AB, OsseoSpeed™ Plus - K120414 Astra Tech AB, OsseoSpeed™ Profile, System - K080156 Astra Tech, Inc., Atlantis™ Abutment in Zirconia for OsseoSpeed TX Profile Implant - K 103759 Astra Tech, Inc., Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus Implant - K 112138 Astra Tech AB, Astra Tech Implant System, New Component - K072624 Astra Tech AB, Astra Tech Implant System - K 101732 Atlantis Components, Inc. AtlantisTM Abutment for Astra Implant - K051652 FRIADENT GmbH, ANK YLOS® Dental Implant System - K041509

The subject device and the predicate devices have intended use and have the same technological characteristics. The subject device and the predicate devices encompass the same range of physical dimensions and characteristics, including diameter, length, angulation and surface treatment. Any differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy.

Performance testing is provided to demonstrate substantial equivalence and includes static and dynamic compression-bending testing according to ISO 14801. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Overall. OsseoSpeed™ Profile 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 and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure. The logo is black and white.

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

October 25, 2013

DENTSPLY Implants C/O Linda K. Schulz, BSDH, RDH PaxMed International, LLC 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130

Re: KI30999

Trade/Device Name: OsseoSpeed™ Profile EV Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 23, 2013 Received: September 24, 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows the name "Mary Si Bunner -S" in a simple, bold font. The text is arranged horizontally, with the name "Mary" appearing first, followed by "Si Bunner" and then "-S". The letters are uniformly sized and spaced, creating a clean and legible presentation of the name. The overall impression is straightforward and professional.

Kwame Ulmer M.S. Acting Division 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

K130999 510(k) Number:

OsseoSpeed™ Profile EV Device Name:

Implants:

The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

· replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
· immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge
· especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective
· immediate and early loading for all indications
· together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate
· only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components

Abutments:

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

The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant.

A TLANTIS™ Abutment, ATLANTIS™ Crown Abutment and ATLANTIS™ Conus Abutment are compatible with ASTRA TECH Implant System Profile EV.

Prescription Use(Part 21 CFR 801 Subpart D)	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)

Page 1 of 1

Susan Runner
DOSPA 2013.10.25 08:23:13
Mary S. Runner -S
04'00"

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.