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.

Device Description

The Straumann® PURE Ceramic Implants (Tissue Level Monotype and Tissue Level two-piece design) are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding instruments and prosthetic parts. The Straumann® PURE Ceramic Implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched (ZLA® surface). The implants have a 1.8 mm high machined transmucosal neck. The Straumann® PURE Ceramic Implant has a two -piece design with internal connection based on features of the Straumann® Tissue Level Standard Plus and Straumann® Bone Level Implants. The Straumann® PURE Ceramic Implant Monotype features a monotype design where the ceramic abutment for final restoration is already built in.

AI/ML Overview

This document, a 510(k) summary for the Straumann® PURE Ceramic Implants, does not contain information about an AI/ML device or a study proving its performance against acceptance criteria in the way a typical AI/ML medical device submission would.

The document describes a dental implant (a physical medical device) and its equivalence to previously cleared predicates. The nonclinical testing mentioned (dynamic fatigue, biological assessment, sterilization validation, packaging stability, MRI compatibility, surface features) are standard tests for physical implants to ensure their safety and effectiveness.

Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an AI/ML device from this document. The concepts of "test set," "ground truth experts," "adjudication," "MRMC study," "standalone performance," "training set," and "how ground truth for training set was established" are not applicable to the non-AI/ML device described in this 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Institut Straumann AG % Jennifer Jackson Sr. Director Regulatory Affairs and Ouality Straumann USA, LLC 60 Minuteman Rd. Andover, Massachusetts 01810

December 10, 2024

Re: K241391

Trade/Device Name: Straumann® PURE Ceramic Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: May 15, 2024 Received: November 15, 2024

Dear Jennifer Jackson:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241391

Device Name

Straumann® PURE Ceramic Implants

Indications for Use (Describe)

The Strauman® PURE Ceramic Implant 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.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Straumann® PURE Ceramic Implants

K241391 510(k) Summary

510(k) Summary

Submitter's Contact Information

Submitter:	Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
	On the behalf of:Institut Straumann AGPeter Merian weg 124052 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MSSr.Director of Regulatory Affairs & QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By:	Corinne ArimateaRA & Compliance ManagerInstitut Straumann AGPhone number: +41619651217
Date Prepared:	December 09, 2024

Name of the Device

Trade Names:	Straumann® PURE Ceramic Implants
Common Name:	Endosseous dental implant
Classification Name:	Endosseous dental implant
Regulation Number:	21 CFR 872.3640
Device Classification:	II
Product Code(s):	Primary product code - DZE

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Straumann® PURE Ceramic Implants

K241391 510(k) Summary

Predicate Device(s)

Primary Predicates:

K171769 Straumann® PURE Ceramic Implants .
Reference Devices:
K180477 Straumann® PURE Ceramic Implants .
. K210336 - Neodent Implant System - Zirconia Implant System
K201491 Neodent Implant System Zirconia Implant System ●

Device Description

Indications for Use

The Straumann® PURE Ceramic Implant 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.

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Straumann® PURE Ceramic Implants

K241391 510(k) Summary

Technological Characteristics

The indications for use and technological characteristics of the subject devices are consistent with those of the primary predicate and reference devices as detailed in the following table.

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Straumann® PURE Ceramic Implants

K241391 510(k) Summary

Table 1. Comparative Summary of the Indications for Use and Technological Characteristics.

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE	REFERENCE DEVICES		EQUIVALENCEDISCUSSION
K Number/name	K241391Straumann® PURECeramic Implants	K171769Straumann® PURECeramic Implants	K180477Straumann PURECeramic Implant System	K210336Neodent ImplantSystem - ZirconiaImplant System	K201491Neodent ImplantSystem - ZirconiaImplant System
Indicationsfor Use	The Straumann® PURECeramic Implant isindicated for restoration insingle tooth gaps and inan edentulous or partiallyedentulous jaw.The prostheticrestorations used aresingle crowns, fixedpartial or full dentures,which are connected tothe implants through thecorrespondingcomponents.The ø3.3 mm reduceddiameter implants arerecommended for centraland lateral incisors only	The Straumann® PURECeramic Implant(Monotype) is indicated forrestoration in single toothgaps and in an edentulousor partially edentulous jaw.The prosthetic restorationsused are single crowns,fixed partial or fulldentures, which areconnected to the implantsthrough the correspondingcomponents.The ø3.3 mm reduceddiameter implants arerecommended for centraland lateral incisors only	The Straumann PURECeramic Implant isindicated for therestoration of single-toothgaps and in edentulous orpartially edentulous jaws.The prostheticrestorations used aresingle crowns, fixedpartial or full dentures,which are connected tothe implants through thecorrespondingcomponents.			Similar to the primarypredicate, the wordmonotype wasremoved since thesubject devicesencompassmonotype and two-piece devices.
Material	Yttrium-stabilizedzirconium dioxide (Y-TZP)	Yttrium-stabilizedzirconium dioxide (Y-TZP)	Yttrium-stabilizedzirconium dioxide (Y-TZP)	Yttrium-stabilizedzirconium dioxide (Y-TZP)	Yttrium-stabilizedzirconium dioxide (Y-TZP)	Identical to primarypredicate
SurfaceTreatment	Sand-blasted, large-grit,acid etched (ZLA®)	Sand-blasted, large-grit,acid etched (ZLA®)	Sand-blasted, large-grit,acid etched (ZLA®)	Sand-blasted, acidetched	Sand-blasted, acid etched	Identical to primarypredicate
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE	REFERENCE DEVICES			EQUIVALENCEDISCUSSION
K Number/name	K241391Straumann® PURECeramic Implants	K171769Straumann® PURECeramic Implants	K180477Straumann PURECeramic Implant System	K210336Neodent ImplantSystem - ZirconiaImplant System	K201491Neodent ImplantSystem - ZirconiaImplant System
ImplantDiameter	Ø3.3 and Ø4.1 mm	Ø3.3 and Ø4.1 mm	Ø4.1 mm	Ø3.75 mm	Ø4.3 mm	Identical to referencedevices K180477 andK171769.
ImplantLength	8, 10, 12 and 14 mm	8, 10, 12 and 14 mm	8, 10, 12 and 14 mm	10, 11.5 and 13 mm	8, 10, 11.5 and 13 mm	Identical to referencedevices K180477 andK171769.
ImplantDesign	Straight cylindrical implantbody & CylindricalMonotype	Cylindrical Monotype	Straight cylindrical implantbody	Apically Tapered formatTrapezoidal threadsprofile	Apically Tapered formatTrapezoidal threadsprofile	Identical to referencedevices K180477 andK171769.
Thread Pitch	0.8 mm	0.8 mm	0.8 mm	n/a	n/a	Identical to referencedevices K180477 andK171769.
SterilizationMethod	Ethylene Oxide	Ethylene Oxide(K171769)Plasma (K151328)	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Identical to referencedevices K180477 andK171769.

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Straumann® PURE Ceramic Implants

K241391 510(k) Summary

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Straumann® PURE Ceramic Implants

K241391 510(k) Summary

Materials

The purpose of this submission is to support a change in the raw material supplier. The Straumann® PURE Ceramic Implants are made of Yttrium-stabilized zirconium dioxide (Y-TZP).

Summary of Nonclinical Testing

Nonclinical testing data submitted or referenced to demonstrate substantial equivalence in this 510(k) includes:

Dynamic fatigue testing was conducted according to the FDA quidance document . "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants" and demonstrated the subject devices are equivalent to the primary predicate and reference devices. The test was conducted in saline (2 Hz and 37°C) at 2 million cycles.
. Biological assessment was performed according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and to the FDA Guidance document Use of International Standard ISO 10993- 1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, (September 8, 2023). Cytotoxicity and chemical extraction tests were performed. No leachable substances were released in cytotoxic concentrations from the test item.
K180477 & K171769 (Institut Straumann AG) referenced for sterilization validation in . accordance with ISO 11135, "Sterilization of health care products -- Ethylene oxide --Requirements for the development, validation and routine control of a sterilization process for medical devices," using the Half Cycle approach of the Overkill method. The subject devices are not represented to be "non-pyrogenic".
K180477 & K171769 (Institut Straumann AG) referenced for the packaging stability . study and shelf-life study in accordance with ASTM F1980.
The Straumann PURE Ceramic implants are non-magnetic and do not include an electrical . component. As such, the subject devices are not acted upon by the application of

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Straumann® PURE Ceramic Implants

K241391 510(k) Summary

magnetic fields typical of Magnetic Resonance Imaging equipment. Therefore, the Straumann PURE Ceramic Implants do not raise concerns regarding electromagnetic compatibility and electrical safety, as the reference devices K180477 and K171769. However, the prosthetic components could be manufactured from metal material that can be affected by MRI environment. The MRI compatibility status must consider the clinically relevant construction, which may include assembly with metal devices that can be affected by MRI such as abutments and screws. Therefore, all devices are deemed to be MR Conditional.

The ZLA® surface features a topography characterized by macro- and micro-roughness . of the subject devices and is identical to the reference devices cleared under K180477 and K171769.

Conclusion

The data included in this submission demonstrate substantial equivalence to the predicate device listed above. Performance testing and comparison to previous clearances show that the subject devices are substantially equivalent.

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.