Talladium abutments are used in connection with the prosthetic restoration of dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. The Talladium abutments fit implants with external hexagon, conical, conical, and other internal (e.g., multi-lobed) implants. A dynamic abutment is available to correct the angulation of an implants. . the the angulation of the dynamic abutments to 20° off of the long axis of the inplant).

The Talladium abutments have been tested with the following implant systems:

Group 1, External Hexagon Abutments: 31 Implant Innovations, Biomet .
. Group 2, Conical Abutments: Nobel Biocare Multi-Unit
. Group 3, Internal Conical Abutments: Zimmer Screw-Vent SD
Group 4, Internal Abutments: Nobel Biocare Replace RP .

Talladium abutments are compatible with the following implants:

3 i Implant Innovations Biomet, Innova, Life-Core, Nobel Biocare, Implamed, Zimmer, IMZ, Bti, Klockner external hexagon implants; Straumann and Nobel Biocare conical implants; Inc., Inc., Inc., Zimmer, BioHorizons and Blue Sky Bio internal hexagonal implants; and Nobel Biocare and Blue Sky Bio Trilobe platform internal connections.

Device Description

The Talladium abutments are an artificial tooth abutment designed to fit and function on root-form endosseous implants having various abutment interfaces: an external hexagon. conical, internal conical, and other internal connections such as multi-lobed. Talladium also has a dynamic abutment to correct the angulation of an implant if necessary.

Talladium's abutments are intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Talladium abutments are prosthetic abutments that fit a variety of endosseous implants listed below. Talladium's abutments are made from tilite, a biocompatible Base Metal Alloy material that is used in dental restorations.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance Study for Talladium International Implantology Abutments (K090081)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Performance	Fatigue Resistance (Dynamic Tests)	"All testing passed the acceptance criteria" (referencing ISO 14801:2007 for dynamic fatigue testing). This indicates mechanical integrity under cyclic loading.
	Static Compression Bending	"All testing passed the acceptance criteria." This indicates the device's ability to withstand static loads without failure.
Biocompatibility	Particulate Formation (Wear)	"SEM testing showed negligible to moderate wear, and wear was comparable or less severe than in similar studies." This indicates that the device does not generate excessive or harmful wear particles.
	Material Biocompatibility	The device is made from "tilite [a] biocompatible Base Metal Alloy material that is used in dental restorations." The 510(k) states that the biocompatibility of this material has "previously been cleared by FDA for use in fixed prosthodontic devices with tissue contact similar to that of the Talladium abutments." This implies that the material itself meets established biocompatibility standards.
Functional Compatibility	Fit with various implant systems	The abutments are "designed to fit and function on root-form endosseous implants having various abutment interfaces: an external hexagon, conical, internal conical, and other internal connections." The devices were tested with specific implant systems (3i Implant Innovations, Biomet, Nobel Biocare Multi-Unit, Zimmer Screw-Vent SD, Nobel Biocare Replace RP) and declared compatible with a wider range of implants (detailed in "Talladium abutments are compatible with the following implants" section). This demonstrates functional fit.
Angulation Correction (Dynamic Abutment)	Limit of angulation correction	The dynamic abutment is designed "to correct the angulation of an implant if necessary (limiting the angulation of the dynamic abutments to 20° off of the long axis of the implant)." While the performance section states that all testing passed acceptance criteria, it doesn't explicitly detail the test results verifying this 20-degree limit for the dynamic abutment, but it's an inherent design specification that is implied to be met by the overall "all testing passed" statement. The study included the dynamic abutment, suggesting its specific performance was assessed.
Regulatory Compliance	Adherence to relevant standards and guidance documents	"The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments; Guidance for Industry and FDA Staff (May 12, 2004) was followed as applicable to this submission." Also, "Performance (fatigue) testing according to ISO 14801:2007 has ensured the appropriate design of the Talladium devices." This indicates compliance with recognized standards and FDA guidance for this device type.
Substantial Equivalence	Equivalence to predicate devices in intended use, design, and performance	The document explicitly states: "The Talladium Abutments are substantially equivalent in terms of intended use, design, and performance to the predicate devices... nonclinical performance testing (fatigue testing and biocompatibility) was used to validate that performance was acceptable for intended use. Taken together, these factors support the substantial equivalence of Talladium abutments to the predicate devices." The detailed Substantial Equivalence Table further highlights similarities in shape, design, and use, and addresses differences (e.g., material not known for predicates, or different materials) by referencing the successful fatigue and biocompatibility testing of the Talladium abutments.

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

Sample Size: The document mentions that static and dynamic tests were performed for "four dental abutment and implant systems, one (the most susceptible) for each type of connection, including the dynamic abutment." This implies a small sample size of at least four representative systems, however, the exact number of individual abutments or tests conducted within each system is not specified.
Data Provenance: The data is generated from non-clinical (laboratory) performance testing conducted by the manufacturer, Talladium España (Lleida, Spain). The origin is therefore prospective as it was specifically performed for this regulatory submission. There is no mention of patient data, retrospective studies, or data from specific countries of origin related to patient outcomes.

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

There were no human experts involved in establishing ground truth for this type of performance testing. The "ground truth" for the mechanical and material performance of these dental abutments is established by objective engineering standards and laboratory measurements as defined by ISO 14801:2007 and general biocompatibility principles for medical devices. The interpretation of these results would typically be done by engineers and material scientists.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "truth" is determined by objective physical and chemical testing against established standards, not by human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a dental implant abutment, not an AI-based diagnostic or therapeutic device that would involve human readers or AI assistance in interpretation.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for this study is based on:

Objective performance standards: Specifically, the requirements and methodologies outlined in ISO 14801:2007 for dynamic fatigue testing, and general principles for static mechanical testing.
Material science principles and established biocompatibility: The assessment of wear particles via SEM and the historical FDA clearance of the "tilite" material.
Engineering design specifications: For example, the 20° angulation limit for the dynamic abutment.

8. The Sample Size for the Training Set

Not applicable. This device does not use an "AI algorithm" that requires a training set. The "training" for this physical device comes from established engineering design principles, manufacturing processes, and material science knowledge.

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

Not applicable, as there is no "training set" in the context of an AI algorithm. The performance is assessed against pre-defined engineering and material standards, not learned from a dataset.

Summary

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Image /page/0/Picture/0 description: The image contains the logo for Talladium International Implantology. The logo features a stylized globe on the left, followed by the word "Talladium" in a large, bold font. Below "Talladium" are the words "International" and "Implantology" in a smaller font, with "Implantology" underlined.

K090081

510(k) Summary

Submitted by: Address:

Esteban Xam-Mar Mangrane Talladium España Av. Madrid 17, alt. 1ª 25002 Lleida (Spain)

JUN 2 2 2010

Telephone:

+34.973289580

Date of Summary:

May 14, 2010

Classification Name: Classification Number: Product Code: Trade Name: 510(k) Number:

Endosseous Dental Implant Abutment 872.3630 NHA Talladium International Implantology Abutments K090081

Legally Marketed Predicate Devices

External Hexagon abutments, e.g., K032263, K925769 Conical abutments, e.g., K990342, K041295, K072570 Internal Conical abutments, e.g., K020096, K060880, K071439 Internal abutments, e.g., K053355, K073345

Device Description

Indication for Use/Intended Use

Talladium abutments are used in connection with the prosthetic restoration of dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. The Talladium abutments fit implants with external hexagon, conical, internal conical, and other internal (e.g., multilobed) implants. A dynamic abutment is available to correct the angulation of an implant if necessary (limiting the angulation of the dynamic abutments to 20° off of the long axis of the implant).

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Image /page/1/Picture/0 description: The image shows the logo for Talladium International Implantology. The logo features a stylized globe on the left, followed by the word "Talladium" in a large, bold font. Below "Talladium" are the words "International" and "Implantology" in a smaller font, with "Implantology" underlined.

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The Talladium abutments have been tested with the following implant systems:

· Group 1, External Hexagon Abutments: 3i Implant Innovations, Biomet
· Group 2, Conical Abutments: Nobel Biocare Multi-Unit
Group 3, Internal Conical Abutments: Zimmer Screw-Vent SD .
· Group 4, Internal Abutments: Nobel Biocare Replace RP

Talladium abutments are compatible with the following implants: 31 Implant Innovations Biomet, Innova, Life-Core, Nobel Biocare, Implamed, Zimmer, IMZ, Bti, Klockner external hexagon implants; Straumann and Nobel Biocare conical implants; Zimmer, BioHorizons and Blue Sky Bio internal hexagonal implants; and Nobel Biocare and Blue Sky Bio Trilobe platform internal connections.

Performance Standards

The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments; Guidance for Industry and FDA Staff (May 12, 2004) was followed as applicable to this submission. Performance (fatigue) testing according to ISO 14801:2007' has ensured the appropriate design of the Talladium devices.

Non-Clinical Performance Data

Static and dynamic tests of compression bending were performed for four dental abutment and implant systems, one (the most susceptible) for each type of connection, according to ISO 14801:2007, including the dynamic abutment. All testing passed the acceptance criteria. In addition, scanning electron microscopy (SEM) was performed to examine particle formation of tested pieces. In all cases, SEM testing showed negligible to moderate wear, and wear was comparable or less severe than in similar studies.

The Talladium abutments are composed of tilite with titanium allov. Biocompatibility of this biomaterial has previously been cleared by FDA for use in fixed prosthodontic devices with tissue contact similar to that of the Talladium abutments.

Basis for Substantial Equivalence

The Talladium Abutments are substantially equivalent in terms of intended use, design, and performance to the predicate devices (see next page). The exact configuration of currently marketed abutments is duplicated in the Talladium abutment series, and nonclinical performance testing (fatigue testing and biocompatibility) was used to validate that performance was acceptable for intended use. Taken together, these factors support the substantial equivalence of Talladium abutments to the predicate devices.

1 180 14801:2007. Dentistry - Implants - Dynamic Fatigue Testing for Endosseus Dental Implants.

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SUBSTANTIAL EQUIVALENCE TABLE

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CATEGORY, 510(k) NUMBER	TRADE NAME, MANUFACTURER	DESCRIPTION	SIMILARITIES	DIFFERENCES	SIGNIFICANCE OF DIFFERENCE
External HexagonK032263	3i Patient-SpecificDental Abutment andOverdenture Bar,Implant Innovations Inc.DZE	Series of dentalabutments andoverdenture bars	Talladium 3i-typeabutments are the sameshape, design and use asK032263	No overdenture bars incurrent 510(k), materialnot known	None
External HexagonK925769	Branemark SystemAbutments Complete,NobelpharmaDZE	Series of abutments	Talladium Branemark-type abutments are thesame shape, design anduse as K925769	Material not known	Talladium material andfatigue testing showsacceptable performance
ConicalK990342	Synocta Prosthesis,StraumannDZE	Series of abutments, andother components	Titanium alloy andother materials	Some materialsdifferent	Talladium material andfatigue testing showsacceptable performance
ConicalK041295	RN Synocta UCLAGold Abutment for theStraumann DentalImplant, InstitutStraumann AGNHA	Series of abutments	Talladium Strauman-type abutments are thesame shape, design anduse as K041295	Material not reported	Talladium material andfatigue testing showsacceptable performance
ConicalK072570	Nobelactive MultiunitAbutment, NobelBiocare ABNHA	Abutment	Talladium NobelBiocare-type abutmentsare the same shape,design and use asK072570	Material not known	Talladium material andfatigue testing showsacceptable performance
Internal ConicalK020096	Esthetic EaseAbutments for the ITIDental Implant System,Institut Straumann AGDZE	System of implants,abutments, surgicalparts, and instrumentsMaterial: Titanium	Talladium Strauman-type abutments are thesame shape, design anduse as K020096	Different material; noimplants in current510(k)	Acceptable changebecause materialsuccessfully tested forbiocompatibility, fatigueand particle formation
Internal ConicalK060880	Zimmer Dental OnePiece TaperedAbutment, Models	Zimmer taperedabutments	Talladium Zimmer-typeabutments are the sameshape, design and use as	None	None
CATEGORY, 510(k)NUMBER	TRADE NAME,MANUFACTURER	DESCRIPTION	SIMILARITIES	DIFFERENCES	SIGNIFICANCE OFDIFFERENCE
Internal ConicalK071439	TA5C1, Zimmer DentalInc.	Zimmer Patient-SpecificAbutment, Internal Hex,Titanium, ZimmerDental Inc.	Titanium alloy, called"patient-specific"	None known	Talladium material andfatigue testing showsacceptable performance
Internal AbutmentsK053355	DZEBTI Interna DentalImplant System, BTIBiotechnology Institute,SL	System of implants andabutments	Talladium BTI-typeabutments are the sameshape, design and use asK053355	Material not reported,no implants in current510(k)	Talladium material andfatigue testing showsacceptable performance
Internal AbutmentsK073345	DZECertain ContouredMarigin CeramicAbutment, Biomet 3iNHA	System of Biomet 3iCertain abutments	Talladium Biomet 3i-type abutments are thesame shape, design anduse as K073345	Different material(ceramic)	Acceptable change -because materialsuccessfully tested forbiocompatibility, fatigueand particle formation

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Image /page/3/Picture/0 description: The image shows the word "Talladium" in a large, bold, sans-serif font. Below the word "Talladium" is the text "International Implantology" in a smaller font. Below the text is a circular logo that is partially obscured.

ਦੂ ਹੈ। ਇਹ ਸਾਲ ਦੀ ਸਾਹਿਤ ਕੀਤੀ ਹੈ। ਇਹ ਸਾਲ ਦੀ ਸਾਹਿਤ ਕੀਤੀ ਹੈ । ਇਸ ਦੀ ਇੱਕ ਸਿੰਘ ਦੇ ਸੰਗਲ ਦੀ ਸਾਹਿਤ ਕੀਤੀ ਹੈ। ਇਸ ਦੀ ਇੱਕ ਸਿੰਘ ਦੇ ਸੰਗਲ ਦੀ ਸਾਹਿਤ ਕੀਤੀ ਹੈ। ਇਸ ਦੀ ਇੱਕ ਸਿੰਘ ਦੇ ਸੰਗਲ ਦੀ ਸਾਹਿਤ ਕ

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

Talladium Europe S.L. C/O Ms. Diane Horwitz Mandell Horwitz Consulting LLC 2995 Steven Martin Drive Fairfax, Virginia 22031

JUN 2 2 2010

Re: K090081

Trade/Device Name: Talladium International Implantology Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 11, 2010 Received: June 16, 2010

Dear Ms. Horwitz:

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. Horwitz

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,

The Arts of the Children WDAY

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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K090081

Indications for Use

510(k) Number (if known): K090081

Device Name: Talladium International Implantology Abutments

Indications For Use:

Talladium abutments are used in connection with the prosthetic restoration of dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. The Talladium abutments fit implants with external hexagon, conical, conical, and other internal (e.g., multi-lobed) implants. A dynamic abutment is available to correct the angulation of an implants. .
the the angulation of the dynamic abutments to 20° off of the long axis of the inplant).

The Talladium abutments have been tested with the following implant systems:

Group 1, External Hexagon Abutments: 31 Implant Innovations, Biomet .
. Group 2, Conical Abutments: Nobel Biocare Multi-Unit
. Group 3, Internal Conical Abutments: Zimmer Screw-Vent SD
Group 4, Internal Abutments: Nobel Biocare Replace RP .

Talladium abutments are compatible with the following implants:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Suasan Sunor

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

510(k) Number: K090081

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.)