Implants:
The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

replacing single and multiple missing teeth in the mandible and 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 loading in all indications, except in single tooth situations on implants shorter . than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.

Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

Atlantis Abutments:
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 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.

Device Description

The purpose of this submission is to expand the OsseoSpeed™ Plus Implant System to include all the components of the previously cleared OsseoSpeed System. The OsseoSpeed Plus Implant System, cleared September 26, 2011 under K111287, has the same design as the OsseoSpeed system, except for addition of an anti-rotation feature to the implant/abutment interface.

The OsseoSpeed Plus System includes implants with diameters ranging from Ø3.0 mm to Ø5.4 mm and lengths ranging from 6 mm to 17 mm. Radiographic guides are available for all implant sizes. Abutments sizes range from Ø3.0 mm to Ø5.4 mm in straight and angled designs ranging from 15° to 30°. Abutment designs include coverscrews, healing abutments, temporary abutments, cast-to abutments, ball abutments, straight and angled abutments.

AI/ML Overview

This 510(k) Premarket Notification for the OsseoSpeed™ Plus Dental Implant System primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. Therefore, the information provided does not detail specific acceptance criteria for a new clinical study and a study that proves the device meets those criteria, as one would typically find for a novel device.

The submission is for an expansion of an existing system (OsseoSpeed™ Plus) to include components from the previously cleared OsseoSpeed System (K111287). The core argument for substantial equivalence is based on the device having the "same intended use and design principles" and "same technological characteristics" as predicate devices, supported by non-clinical testing.

Here's an analysis of what is available in the document, acknowledging that typical clinical study acceptance criteria and results are not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission relies on substantial equivalence and non-clinical testing, explicit acceptance criteria tied to a clinical performance study with defined metrics (e.g., success rates, complication rates) are not provided in the document.

The "acceptance criteria" here are implicitly linked to demonstrating that the OsseoSpeed™ Plus system is as safe and effective as the predicate devices. The non-clinical data presented aims to show that any differences in technological characteristics do not raise new issues of safety or efficacy.

Acceptance Criteria Category	Specific Criteria (Implicit/Referenced)	Reported Device Performance (as demonstrated by submission)
Intended Use Equivalence	Device has the same intended use as predicate devices (replacing single/multiple missing teeth, immediate placement, soft bone applications, immediate loading within specified limits).	The OsseoSpeed™ Plus system has the same stated intended uses as its predicate devices, including replacement of single/multiple missing teeth, immediate placement, soft bone applications, and immediate loading within specified limitations (e.g., OsseoSpeed Plus 3.0S limited to maxillary lateral and mandibular incisors).
Technological Characteristics Equivalence	Device has the same or very similar design, operating principle, materials, physical dimensions (diameter/length of implants, diameter/height/angle of abutments), packaging, and sterilization methods as predicate devices. The only noted design difference (anti-rotation feature) does not introduce new safety/efficacy concerns.	The OsseoSpeed™ Plus system has the "same design as the OsseoSpeed system, except for addition of an anti-rotation feature". It incorporates the same basic design, operating principle, and materials, with a comparable range of physical dimensions for implants and abutments. Packaging and sterilization methods are also similar to predicate devices. The non-clinical testing supports that the anti-rotation feature does not compromise safety/efficacy.
Non-Clinical Performance Equivalence (Referenced)	Device performance in mechanical and physical tests (engineering analysis, dimensional analysis, surface area/bone-to-implant contact area analysis, static/dynamic compression-bending testing according to ISO 14801) is comparable to predicate devices and acceptable for intended use. The objective is to demonstrate that any differences in technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy.	"Non-clinical testing data provided or referenced to demonstrate substantial equivalence included detailed engineering analysis, dimensional analysis, surface area and bone-to-implant contact area analysis, and static and dynamic compression-bending testing according to ISO 14801." The FDA's clearance (K120414) implies that these data satisfied the agency that substantial equivalence was demonstrated.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as there is no specific clinical test set described from a prospective study. The evaluation relies on non-clinical engineering and bench testing data, and the historical performance of the predicate devices. The document does not specify sample sizes for the non-clinical tests, other than referencing the types of tests performed (e.g., ISO 14801).
Data Provenance: The referenced predicate devices would have been previously marketed (interstate commerce prior to May 28, 1976, or reclassified devices). The non-clinical testing data would typically be generated in a lab setting by the manufacturer (Astra Tech AB, Sweden, or its testing partners).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This question is not applicable for this submission. The ground truth, in the absence of a clinical study, is the established safety and efficacy of the predicate devices, supported by the non-clinical testing confirming that the new device variant performs similarly. Expert consensus on clinical outcomes for a novel test set is not described.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring an adjudication method by experts for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. This type of study is not mentioned or implied in this 510(k) submission, as it focuses on dental implants, not image-based diagnostic aids or similar devices where MRMC studies are common.

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

Not applicable. The OsseoSpeed™ Plus is a physical dental implant system, not a software algorithm or AI-driven device.

7. The type of ground truth used

The "ground truth" for this 510(k) clearance is primarily:
- The established safety and efficacy profile of the legally marketed predicate devices.
- Bench test results and engineering analyses (e.g., mechanical strength, dimensional accuracy, surface characteristics) demonstrating that the subject device performs comparably to the predicates and meets relevant standards (like ISO 14801).
- The regulatory precedent set by the predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a machine learning algorithm for this physical device. If referring to product development and testing, the sample size for non-clinical tests would be defined by engineering standards and internal validation protocols, but specific numbers are not provided in this summary.

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

Not applicable. As there is no training set for an AI algorithm, this question doesn't apply. The "ground truth" for the overall submission is based on regulatory precedent and engineering validation against established standards and predicate devices.

Summary

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510(k) Premarket Notification

. :

OsseoSpeed TM Plus

510(k) Summary Astra Tech AB OsseoSpeed™ Plus K120414

July 23, 2012

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 +1 (858) 792-1235 Telephone: +1 (858) 792-1236 Fax: lschulz@paxmed.com Email: kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name:

Classification Regulation: Product Code:

Classification Panel: Reviewing Branch:

OsseoSpeed™ Plus Dental implant and abutment Implant, endosseous, root form Endosseous dental implant abutment

Class II, 21 CFR 872.3640 DZE, NHA

Dental Products Panel Dental Devices Branch JUL 3 1 2012

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INTENDED USE

Implants:

The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

replacing single and multiple missing teeth in the mandible and 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 loading in all indications, except in single tooth situations on implants shorter . than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.

Abutments:

Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

Atlantis Abutments:

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.

DEVICE DESCRIPTION

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ranging from 15° to 30°. Abutment designs include coverscrews, healing abutments, temporary abutments, cast-to abutments, ball abutments, straight and angled abutments.

EQUIVALENCE TO MARKETED DEVICE

Astra Tech OsseoSpeed™ Plus Implant System is substantially equivalent in indications for use and design principles to the following legally marketed predicate devices:

K111287,K101732,K091239,K080396. Implants: K120338, K112138, K111390, K110356, K101849, K101005, K083805, Abutments: K083496, K081666, K072624, K063286, K980698, K974738, K931767.

The subject device and the predicate devices have the same intended use and have the same technological characteristics and are made of the same materials. They encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.

Non-clinical testing data provided or referenced to demonstrate substantial equivalence included detailed engineering analysis, dimensional analysis, surface area and bone-to-implant contact area analysis, and static and dynamic compression-bending testing according to ISO 14801.

Any differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy.

The data included in this submission demonstrates substantial equivalence to the predicate devices listed above. .

Overall, OsseoSpeed Plus 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 seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Astra Tech AB C/O Ms. Linda K. Schulz Senior Regulatory Affairs Specialist PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

JUL 3 1 2012

Re: K120414

Trade/Device Name: OsseoSpeed™ Plus Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 23, 2012 Received: July 24, 2012

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.

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

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,

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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510(k) Summary

Indications for Use

K120414 510(k) Number:

OsseoSpeed™ Plus Device Name:

Indications for Use:

Implants:

The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

replacing single and multiple missing teeth in the mandible and 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 loading in all indications, except in single tooth situations on implants shorter than ● nimounting in an an in in in in in in the implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.

Abutments:

Atlantis Abutments:

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 a partially or ething and ble 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 a sabotable is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

Prescription Use	X	AND/OR Over-The-Counter
(Part 21 CFR 801 Subpart D)		(21 CFR 80)

510(k) Number: __

Counter Use 01 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


(Division Sign-Off)Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

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.