The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

The Ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months.

Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days.

Device Description

The Straumann® PURE Ceramic Implant (Monotype) is made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness to support osseointegration (ZLA® surface). The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant (Monotype) prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.

The Protective Caps are manufactured from polyetheretherketone (PEEK Classix).

The temporary copings are manufactured from polymethylmethacrylate (PMMA).

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, approving the Straumann® PURE Ceramic Implants. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not describe a study that validates the device against acceptance criteria in the way a clinical trial or performance study for an AI/diagnostic device would.

The "acceptance criteria" mentioned in the document refers to the success rate of the implant in a clinical study, which is a different type of acceptance criteria than what would be presented for an AI device.

Let's break down what information is available based on your request and what is not available for a device like this.

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

For an AI/diagnostic device, acceptance criteria would typically involve metrics like sensitivity, specificity, AUC, etc., compared against predefined thresholds. For this dental implant, the primary "acceptance criterion" mentioned is the clinical success rate.

Acceptance Criteria (Clinical Success)	Reported Device Performance (Clinical Study)
Exceeded 85% survival rate in the protocol	97.6% survival rate at two years (among 41 ITT patients with complete follow-up)

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 for Test Set (Clinical Study): 41 ITT (Intent-To-Treat) patients with complete follow-up through two years.
Data Provenance: Not explicitly stated in terms of country of origin. The study appears to be a prospective clinical follow-up as it refers to patients' survival to at least two years.

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)

This section is not applicable to this type of device and study. For an implant, "ground truth" would be the patient's clinical outcome (survival, successful integration, etc.), not an expert's interpretation of an image or a condition.

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

This section is not applicable. Adjudication methods like 2+1 (two readers agree, third adjudicates disagreement) are used for diagnostic interpretations, not for direct clinical outcomes of an implant. The outcomes (survival) are directly observed.

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

This section is not applicable. This is not an AI or diagnostic device, so there is no concept of human readers or AI assistance.

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

This section is not applicable. This is not an AI algorithm.

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

Type of Ground Truth: Outcomes data (specifically, implant survival/success at two years).

8. The sample size for the training set

This section is not applicable. This is not a machine learning or AI device that requires a training set. The clinical study investigated the implant's performance directly.

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

This section is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with three curved lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

January 11, 2016

Straumann USA Ms. Nandini Murthy Regulatory Consultant 60 Minuteman Road Andover, Massachusetts 01810

Re: K151328

Trade/Device Name: PURE Ceramic Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 8, 2015 Received: December 9, 2015

Dear Ms. Murthy:

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, Tina Kiang S

for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K151328

Device Name

PURE Ceramic Implants

Indications for Use (Describe)

The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months.

Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

□ Over-The-Counter Use (21 CFR 801

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number

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510(k) Summary

1.1 Submitter's Contact Information

Straumann USA, LLC (on behalf of Institut Straumann AG)

60 Minuteman Road

Andover, MA 01810

Phone Number:	1-978-747-2509
---------------	----------------

Fax Number: 1-978-747-0023

Contact Person: Jennifer Jackson

Date of Submission: January 11, 2016

1.2 Name of the Device: PURE Ceramic Implants

Trade Name:	Straumann® PURE Ceramic Implants
-------------	----------------------------------

Common Name: Endosseous Dental Implant
Classification Name: Endosseous Dental Implant
Regulation Number: §872.3640
Classification: Class II
Product codes: DZE, NHA

Straumann® PURE Ceramic Protective Caps 1.2.1

Straumann® PURE Ceramic Protective Caps Trade Name:
Endosseous Dental Implant Abutment Common Name:

1.2.2 Straumann® PURE Ceramic Temporary Copings

Straumann® PURE Ceramic Temporary Copings Trade Name:
Common Name: Endosseous Dental Implant Abutment

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Predicate Device 1.3

1.3.1 Primary Predicate Device

K120793, Z-Look3 Evo SLM .

1.3.2 Reference Predicate Device(s)

. K033922, Modification to ITI Dental Implant System
. K062129, P.004 Implants
K123784, Straumann® Dental Implant System .
. K111357, Narrow Neck CrossFit (NNC) Ø3.3 mm Dental Implant System
K072071, Straumann P.004 Cementable Abutments ●
K080286, Straumann P.004 NC Cementable Abutments .

Device Description 1.4

1.4.1 PURE Ceramic Implants

The full range of size ranges of the PURE Ceramic implants are provided in Table 1 below.

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K151328
Straumann® PURE Ceramic Implants

Implant Overview	Straumann® PURE Ceramic Implant Ø3.3 ND		Straumann® PURE Ceramic Implant Ø4.1 RD
Prosthetic Platform	ND	ND	RD	RD
Abutment height	AH 4 mm	AH 5.5 mm	AH 4 mm	AH 5.5 mm
Shoulder diameter	Ø3.5 mm	Ø3.5 mm	Ø4.8 mm	Ø4.8 mm
Image: Four Straumann PURE Ceramic Implants
Endosteal diameter	Ø3.3 mm	Ø3.3 mm	Ø4.1 mm	Ø4.1 mm
Length	8 mm	031.001S	031.011S	031.021S	031.031S
	10 mm	031.002S	031.012S	031.022S	031.032S
	12 mm	031.003S	031.013S	031.023S	031.033S
	14 mm	031.004S	031.014S	031.024S	031.034S

Table 1 – Full range of Straumann® PURE Ceramic Implants

1.4.2 Straumann® PURE Ceramic Protective Caps

The Protective Caps are manufactured from polyetheretherketone (PEEK Classix). The full range of Protective Caps is provided in Table 2.

Protective Cap Overview	AH 4 mm	AH 5.5 mm
	Image: AH 4 mm	Image: AH 5.5 mm
For Ø3.3 (ND)	031.320	031.321
For Ø4.1 (RD)	031.330	031.331

Table 2 – Full range of Straumann® PURE Ceramic Implant Protective Caps

Straumann® PURE Ceramic Temporary Copings 1.4.3

The temporary copings are manufactured from polymethylmethacrylate (PMMA). The full range of temporary copings is provided in Table 3.

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K151328 Straumann® PURE Ceramic Implants

Temporary Coping Overview	For Crowns	For Bridges
	Image: crown	Image: bridge
For Ø3.3 (ND)	031.300	031.301
For Ø4.1 (RD)	031.310	031.311

Table 3 – Full range of Straumann® PURE Ceramic Implant temporary copings

1.5 Intended Use

Straumann® PURE Ceramic Implants 1.5.1

The Straumann® PURE Ceramic Implant (Monotype) is suitable for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients (unless specific indications and limitations are specified).

1.6 Indications for Use

1.6.1 Straumann® PURE Ceramic Implants

The Ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

Straumann® PURE Ceramic Protective Caps 1.6.2

The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months.

1.6.3 Straumann® PURE Ceramic Temporary Copings

Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days.

Straumann USA, LLC

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1.7 Technological Characteristics

The Straumann® PURE Ceramic Implant is a one-piece monotype implant and therefore does not have an internal connection. Table 4 below provides for a comparison of key technological characteristics and indications between the Straumann® PURE Ceramic Implant and the primary predicate device. The indications are substantially equivalent to the primary predicate, as any differences relate to placement limitation due to reduced diameter implant size and the addition of protective cap and temporary coping device components.

Features	Straumann® PURE Ceramic Implants(K151328)	Predicate Z-Look3 Evo SLM(K120793)
Indications foruse	The Straumann® PURE Ceramic Implant(Monotype) is indicated for restoration in singletooth gaps and in an edentulous or partiallyedentulous jaw. The prosthetic restorations usedare single crowns, fixed partial or full dentures,which are connected to the implants through thecorresponding components.The ø3.3 mm reduced diameter implants arerecommended for central and lateral incisorsonly.The Straumann® PURE Ceramic ImplantProtective Cap is intended to protect theStraumann® PURE Ceramic Implant (Monotype)during the healing phase after implant placementfor up to 6 months.Temporary copings are intended to serve as abase for temporary crown or bridge restorationfor the Straumann® PURE Ceramic Implant(Monotype) for up to 30 days.	Z-look3 evo slm implants are designedfor surgical implantation into the upperand lower jaw for the attachment ofprosthodontic appliances to replacemissing teeth. The z-look3 evo slmimplant system is also suitable forpatients with metal allergies and thechronic diseases resulting from them.
Material	Y-TZP	Y-TZP
Implant Design	Cylindrical Monotype	Cylindrical Monotype
Apical Diameter	Ø3.3 and Ø4.1 mm	Ø3.6, Ø4.0, and Ø5.0 mm
Length	8, 10, 12, and 14 mm	8, 10, 11.5, and 13 mm
Implant/Abutmentconnection	None (Monotype)	None (Monotype)

Table 4 – Comparison of Straumann® PURE Ceramic Implants to Predicate Z-Look3 Evo SLM

1.8 Performance Testing

Dynamic fatigue, static strength, insertion torque and surface characterization tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and showed that the Straumann® PURE Ceramic implants were equivalent to the predicate devices. Specifically, the fatigue strength of the Ø3.3 mm Straumann® PURE ceramic implant was equivalent to the Ø3.6 mm predicate device's fatigue strength. The insertion torque values of the Straumann® PURE Ceramic Ø3.3 mm implant were

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measured and compared to the values of a predicate reference device (Straumann® NNC implant, K111357).

MRI testing was performed to support the MRI statements in Straumann® PURE Ceramic labeling.

The Straumann® PURE Ceramic Implants are manufactured from yttrium-stabilized zirconium oxide (Y-TZP). The material conforms to ISO 13356:2008, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). In addition to prior proven biocompatibility of implant material used, including a toxicological evaluation report and conformance to ISO13356, the following testing was performed:

Cytotoxicity according to ISO 10993-5:2009, Biological evaluation of medical devices -. Part 5: Test for in vitro cytotoxicity.
. Chemical Analysis (organic and inorganic) according to ISO 10993-18:2009, Biological evaluation of medical devices – Part 18: Chemical characterization of materials.
. A rabbit study comparing unaged ceramic implants with aged implants.

All of the testing above, along with a literature review, confirmed the biocompatibility of the Straumann® PURE Ceramic implants.

Sterilization validation of the Straumann® PURE Ceramic implants, in accordance with DIN EN 556-1:2002 (equivalent to ANSI AAMI ST67:2011), Sterilization of medical devices – Requirements for medical devices to be designated "STERILE" – Part 1: requirements for terminally sterilized devices, was completed. The sterilization process for the provisional components as recommended in labeling was also validated according to applicable recommendations in the FDA Guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". Straumann performed accelerated and real time aging testing to support the labeled shelf life.

Clinical study results support the equivalence of the Straumann® PURE Ceramic implants to predicate devices. Among the 41 ITT patients with complete follow-up through two years, 40 survived to at least two years (point estimate of 97.6%), which exceeded the acceptance criteria of 85% in the protocol.

Conclusion 1.9

The documentation submitted in this premarket notification demonstrates that the Straumann® PURE Ceramic Implants are substantially equivalent to the predicate 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.