The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

Device Description

CM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto CM Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body with an internal channel for the screw access and of a base for anti-rotational implant connection. The customizable portion is manufactured in PEEK (high performance polymer – specific for dental use) and the implant-to-abutment interface is made of titanium alloy. They have a coupled screw for fixing them to the Implant. They present a hexagonal indexing at the apical end of the Morse taper connection to provide anti-rotational feature to the implant-to-abutment connection, and facilitates proper alignment of the prosthesis to the implant. They are available in diameters of 4.5 and 6.0 mm and in lengths of 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 mm. The customization of the PEEK chimney must be done into the mouth of patient or chairside. Chairside customization means that the device preparation must be done in a controlled environment in the operating room, in the context of the prosthetic placement, in a surgical site's aseptic environment using sterilized tools. The dentist can wear the PEEK chimney with the aid of suitable techniques, high speed handpiece and cooling, according to the patient interocclusal space, respecting the minimum of 5mm of height. No customization is allowed for the diameter/ wall thickness of the abutment, as well as no angulation. No CAD/CAM design and fabrication is allowed for the CM Pro PEEK Abutments. Only hand-milling may be used for abutment modification. The CM Pro PEEK abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	No extracts of leachable substances of concern were identified. No cytotoxicity response was observed. (Assessed according to ISO 10993-1, ISO 10993-5, ISO 10993-18)
Mechanical Strength (Dynamic Fatigue)	Strength demonstrated through fatigue testing. (Performed according to ISO 14801 and FDA Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments)
Sterilization Assurance Level (SAL)	SAL of 10⁻⁶ achieved. (Validated by bioburden method, according to ISO 11135)
Ethylene Oxide (EO) Sterilization Residuals	Less than the maximum allowable limits. (Verified according to ISO 10993-7)
Sterile Barrier Shelf Life	2 years. (Determined through real-time and accelerated aging protocol, according to ASTM F1980. Tested for sterility, thermal seal integrity, and tensile strength of thermal seal according to ISO 11737, US Pharmacopeia, ASTM E499/E499M, ASTM F1929, and ASTM F88/F88M)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the "test set" in terms of number of devices for biocompatibility, mechanical, or sterilization testing. It mentions "samples" were submitted for testing.

The data provenance is from laboratory testing performed by or for JJGC Indústria e Comércio de Materiais Dentários SA, a company based in Curitiba, Parana, BRAZIL. The clinical data was not submitted or relied upon, so the testing is likely retrospective in the sense that it's laboratory data, not data gathered from human trials.

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

This information is not applicable as the studies conducted are laboratory-based performance tests (biocompatibility, mechanical, sterilization validation) and do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way it's typically understood for AI/diagnostic devices. The acceptance criteria are based on established international standards (ISO, ASTM) and FDA guidance documents.

4. Adjudication Method for the Test Set

This is not applicable for the type of laboratory performance studies described. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of medical images or clinical outcomes, which did not occur here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study involved laboratory performance testing of the device itself, not a comparison of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (dental abutment), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests consists of:

Compliance with international standards: ISO 10993 series for biocompatibility, ISO 14801 and FDA Guidance for Mechanical Strength, ISO 11135 and ISO 10993-7 for Sterilization, and ASTM F1980, ISO 11737, US Pharmacopeia, ASTM E499/E499M, ASTM F1929, and ASTM F88/F88M for Shelf Life.
Predicate device characteristics: The subject device's performance is compared against the established performance and characteristics of legally marketed predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical dental abutment, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a physical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

JJGC Industria e Comercio de Materiais Dentarios SA % Jennifer Jackson Senior Manager, Regulatory Affairs & Quality Management Straumann USA, LLC 60-100 Minuteman Rd Andover, Massachusetts 01810

November 2, 2017

Re: K170080

Trade/Device Name: Neodent Implant System - CM Pro PEEK Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 25, 2017 Received: September 26, 2017

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 (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 of medical device-related 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S

for Tina Kiang, Ph.D. Acting 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

510(k) Number (if known)

K170080

Device Name

Neodent Implant System - CM Pro PEEK Abutments

Indications for Use (Describe)

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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510(k) Summary

Submitter	Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315Owner/Operator No.: 9005052
	on behalf of:
	JJGC Indústria e Comércio de Materiais Dentários SAAv. Juscelino Kubitschek de Olivera, 3291Curtiba, Parana, BRAZIL 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702
Contact Person	Jennifer M. Jackson, MSDirector, Regulatory Affairs & Quality, Straumann USAE-Mail: jennifer.jackson@straumann.comTelephone (978) 747-2509
Date Prepared	02/November/2017
Prepared by	Ana Carolina Martins ViannaRA & Compliance Manager, Institut Straumann AGana.vianna@straumann.com
Product CodeDevice ClassClassification PanelClassification NameCommon NameProprietary name	NHA (21 CFR 872.3630)IIDentalEndosseous dental implant abutment (21 CFR 872.3630)Endosseous dental implant abutmentNeodent Implant System - CM Pro PEEK Abutments
Primary PredicateDevicesReference Devices	K093027 - Straumann RC Temporary Abutments, InstitutStraumann AGK101945 - Neodent Implant System, JJGC Indústria e Comércio deMateriais Dentários SAK133510 - Neodent Implant System, JJGC Indústria e Comércio deMateriais Dentários SA

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5.1 Device Description

They present a hexagonal indexing at the apical end of the Morse taper connection to provide anti-rotational feature to the implant-to-abutment connection, and facilitates proper alignment of the prosthesis to the implant.

They are available in diameters of 4.5 and 6.0 mm and in lengths of 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 mm.

Image /page/4/Picture/6 description: The image shows a dental implant abutment. The abutment is made of two parts: a white ceramic or composite material on top and a silver-colored metal base. The metal base has a threaded screw at the bottom for attachment to the implant fixture in the jawbone. The abutment is designed to connect the implant to a dental crown or other restoration.

Figure 1: Model of CM Pro PEEK abutment

The customization of the PEEK chimney must be done into the mouth of patient or chairside. Chairside customization means that the device preparation must be done in a controlled environment in the operating room, in the context of the prosthetic placement, in a surgical site's aseptic environment using sterilized tools. The dentist can wear the PEEK chimney with the aid of suitable techniques, high speed handpiece and cooling, according to the patient interocclusal space, respecting the minimum of 5mm of height. No customization is allowed for the diameter/ wall thickness of the abutment, as well as no angulation. No CAD/CAM design and fabrication is allowed for the CM Pro PEEK Abutments. Only hand-milling may be used for abutment modification.

The CM Pro PEEK abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase.

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5.2 Indications for Use

5.3 Technological Characteristics

The temporary abutments made of PEEK are designed to be substantially equivalent to the predicate devices previously cleared per K093027.

The subject and predicate devices are based on the following same technological elements:

Endosseous dental abutments to provide support for temporary restorations (primary predicate device);
-Possibility of use in single or two-stage procedures, for single or multiple-unit restorations (reference devices);
-Same sterilization methods and packaging (reference devices).

The following technological differences exist between the subject and predicate devices:

Design of Morse taper implant-to-abutment interfaces; -
-The subject abutment is provided sterile by EO exposition whereas its primary predicate device is provided non-sterile for end-user sterilization.

In the end of this Section, a comparison between the features of subject device and its predicate devices is shown in a tabular format. The assessment of the differences is also included.

5.4 Performance data

The following performance data supports the substantial equivalence determination:

Biocompatibility testing

The raw material PEEK used in fabrication of the CM Pro PEEK Abutments is the same of that cleared for the predicate device under K093027. Any difference in the biocompatibility posed by differences in the manufacturing process has been addressed by chemical characterization and cytotoxicity assessments. No extracts of leachable substances of concern were identified and no cytotoxicity response was observed.

The Biological Assessment has been performed according to ISO 10993-1 Biological evaluation of medical devices. Evaluation and testing, ISO 10993-5 Biological evaluation of medical devices. Tests for in vitro cytotoxicity and ISO 10993-18 Biological evaluation of medical devices. Chemical characterization of materials.

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Mechanical testing

The strength of the CM Pro PEEK Abutment is demonstrated through fatigue testing performed according to ISO 14801 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

Sterilization validation

The subject abutments are sterilized by exposure to ethylene oxide (EO). Sterilization has been validated by the bioburden method, according to ISO 11135 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices. EO sterilization residuals have been verified to be less than the maximum allowable limits as defined in ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. All methods achieve a Sterility Assurance Level (SAL) of 10-6.

The subject devices are not represented to be non-pyrogenic.

Shelf life was determined through both real time and accelerated aging protocol, according to ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. After aging, samples were submitted to sterility test, thermal seal integrity test and tensile strength of thermal seal according to ISO 11737 - Sterilization of medical devices -Microbiological methods - Part 2: Tests of sterility Performed in the definition, validation and maintenance of a sterilization process and US Pharmacopeia; ASTM E499/E499M Standard Practice for Leaks Using the Mass Spectrometer Leak Detector in the Detector Probe Mode, ASTM F1929 Standard Test Method for detecting Seal Leaks in Porous Medical Packaging by Dye Penetration and ASTM F88/F88M Standard Test Method for Seal Strength of Flexible Barrier Materials.

The sterile barrier shelf life for the subject devices is 2 years.

Clinical data

No clinical data has been submitted, referenced, or relied upon to demonstrate substantial equivalence.

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Table 1: Comparison between the subject and predicate devices.

	SUBJECT DEVICES	PRIMARY PREDICATEDEVICES	REFERENCE DEVICES
	Neodent Implant System -CM Pro PEEK Abutment	Straumann RC TemporaryAbutment (K093027)	Neodent Implant System(K101945)	Neodent Implant System(K133510)	EQUIVALENCE DISCUSSION
Indications forUse	The Pro PEEK Abutments areindicated to be used onNeodent implants to providetemporary support forprosthesis structure for upto 6 months. They can beused in one or two stageprocedures and alsoimmediate load when thereis good primary stability.	The Straumann RCTemporary Abutments areindicated for use inStraumann RC Bone LevelImplants for temporaryrestorations of single crownsand bridges for up to sixmonths	The Neodent ImplantSystem is intended to besurgically placed in thebone of the upper or lowerjaw to provide support forprosthetic devices such asartificial teeth, to restorechewing function. It may beused with single-stage ortwo-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusalloading. Multiple toothapplications may be rigidlysplinted.	The Neodent ImplantSystem is intended to besurgically placed in thebone of the upper or lowerjaw to provide support forprosthetic devices such asartificial teeth, to restorechewing function. It may beused with single-stage ortwo-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusalloading. Multiple toothapplications may be rigidlysplinted	EquivalentThe Indications for Use forthe subject and primarypredicate devices are similarwith the exception of minorwording differences.The intention to providesupport to temporaryrestorations is the same.The subject deviceIndications for Usereferences the term"prosthesis structure" whichis an overarching term thatencompasses both crownsand bridges.The specific indication forimmediate load when thereis good primary stability isdependent on the implantIndications for Use. Theimplants also need to beindicated for immediateloading when good primarystability is achieved.
	SUBJECT DEVICES	PRIMARY PREDICATEDEVICES	REFERENCE DEVICES		EQUIVALENCE DISCUSSION
	Neodent Implant System –CM Pro PEEK Abutment	Straumann RC TemporaryAbutment (K093027)	Neodent Implant System(K101945)	Neodent Implant System(K133510)
PlatformDiameter(s)	4.5 and6 mm	4.5 mm	NA(only permanentabutments)	3.3 mm4.1/4.3 mm5.0 mm	EquivalentSubject device diameters arethe same of the predicatedevices or larger. Largerdiameters do not represent aworst case in terms ofperformance.
Material	Titanium alloy Ti-6Al-4V ELIPEEK (polyetheretherketone)	Titanium alloy (Ti-6Al-7Nb,TAN)PEEK (polyetheretherketone)	Titanium Grade 4Titanium alloy Ti-6Al-4V ELI	Titanium alloy Ti-6Al-4V ELI	EquivalentThe subject and thepredicate devices are madeof the same type of rawmaterial; the adequacy of thesystems have beendemonstrated via dynamicfatigue tests andbiocompatibility assessment.
Implant-to-AbutmentConnection	CM interface; 11.5° Morsetaper with anti-rotationalfeatures.	Morse taper interface withanti-rotational features	CM interface; 11.5° Morsetaper with anti-rotationalfeatures.	HE (external hexagon)interface	EquivalentThe performance of eachinterface has been assessedby dynamic fatigue testing.

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	SUBJECT DEVICES	PRIMARY PREDICATEDEVICES	REFERENCE DEVICES
	Neodent Implant System –CM Pro PEEK Abutment	Straumann RC TemporaryAbutment (K093027)	Neodent Implant System(K101945)	Neodent Implant System(K133510)	EQUIVALENCE DISCUSSION
Compatibility	Compatible with NeodentCM implants	Compatible with Straumannimplants	Compatible with NeodentCM implants	Compatible with NeodentHE implants	EquivalentThe interfaces of Neodentand Straumann devices arenot interchangeable. Theirperformances are assessedrespecting the fixturescompatibility.
Sterility	Delivered sterile by EOexposure.	Delivered non-sterile. To besterilized by user beforeplaced in patient mouth(moist steam sterilization).	Delivered sterile by EOexposure.	Delivered sterile by gammairradiation.	EquivalentThe sterilization method andposterior handling of thedevice is the same as thereference devices.

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5.5 Conclusions

The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices.

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.)