The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges. The Klockner Dental Implant Abutments include protective cap, temporary abutment, angled abutments, straight abutments, cast abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential EC 1.5.

Device Description

Klockner Dental Implant Abutments (II) consist of a group of prosthetic components to be used with dental implants as an aid in prosthetic rehabilitation. According to their function, they are classified in:

Protective cap, made of titanium alloy, intended to be provisionally connected to dental abutment as a protection when choosing direct oral impression on the abutment.
Temporary abutment, made of titanium alloy, intended to be provisionally connected to dental abutment to retain a provisional screw-retained multiple-unit restoration.
Angled abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations. These abutments, used when it is necessary to correct prosthesis axis with respect to implant axis, are available with different angulation and different transmucosal height, enabling the anatomic characterization of the gum margin and facilitating the prosthetic fitting.
Straight abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations, with not correction of implant angulation. These abutments are available with different transmucosal height, enabling the anatomic characterization of the qum margin and facilitating the prosthetic fitting.
Cast abutments, made of gold alloy and Co-Cr-Mo alloy, intended for cement-retained single- unit and multiple-unit restorations and for screw-retained single-unit restorations on dental implants using the casting technique.
All these abutments are designed for Klockner Dental Implant Systems, models Essential EC (K080224) and Essential EC 1.5 (K082200), with internal octagonal cone connection.

AI/ML Overview

The document is a 510(k) premarket notification for the Klockner Dental Implant Abutments (II). Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, summarized format. Instead, it states that "Fatigue testing, conducted according to ISO 14801 and the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, has been performed considering worst-case conditions." It then reports that "Results obtained show that devices performance is acceptable as per their intended use."

To infer the acceptance criteria and reported performance, we can deduce them from the referenced standard, ISO 14801, which outlines specific fatigue test methods for dental implants. The acceptance criterion for fatigue testing according to ISO 14801 typically involves surviving a certain number of load cycles (e.g., 5 million cycles) at a specified load without fracture or permanent deformation beyond acceptable limits. The reported performance is a general statement that the device met these implicit criteria.

A hypothetical table based on common ISO 14801 requirements would look like this:

Acceptance Criteria (Implied by ISO 14801)	Reported Device Performance
Fatigue Strength: Device must withstand 5 million cycles at a specified load (stress) without fracture or permanent deformation.	"Devices performance is acceptable as per their intended use." (This implies the devices met the fatigue strength requirements of ISO 14801)
Corrosion Resistance: (For Co-Cr cast abutments) Confirm high corrosion resistance.	"Test results confirm the high corrosion resistance of Co-Cr-Mo alloy"
Galvanic Corrosion: (For Co-Cr cast abutments) Show insignificant galvanic corrosion with unalloyed titanium (Ti c.p.) and titanium alloy (Ti-6Al-4V).	"show an insignificant galvanic corrosion of this material with respect to unalloyed titanium (Ti c.p.) and titanium alloy (Ti-6Al-4V)."
Biocompatibility: All materials used in the manufacture must be biocompatible according to ISO 10993-1:2009 and ISO 7405:2008.	"All materials used... have been subject to biological evaluation... according to the requirements of applicable recognized standards ISO 10993-1:2009 and ISO 7405:2008." (Additional biocompatibility testing was not considered necessary as materials are identical to previously cleared devices).
Sterilization: Bioburden and sterility testing accordance with ISO 11737-1 and ISO 11737-2. Steam sterilization validation according to ISO 17665-1.	"Klockner Dental Implant Abutments (II) have been subject to bioburden and sterility testing... Steam sterilization validation according to ISO 17665-1 has been carried out."

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

Sample Size for Test Set: The document does not specify the exact sample size for the bench testing (fatigue testing, corrosion tests, etc.). It mentions "worst-case conditions" but no specific number of units tested.
Data Provenance: The studies are non-clinical (bench testing) performed by SOADCO, S.L., the manufacturer, which is based in Andorra. The data is prospective in the sense that the tests were conducted specifically for this submission, but it's not clinical patient data.

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

This is not applicable as the studies are non-clinical bench tests. "Ground truth" in this context refers to standardized measurements and material properties according to recognized standards (e.g., ISO 14801, ISO 10993, ASTM standards). The "truth" is established by the test protocols and the physical properties of the materials and device design, not by expert consensus on observable phenomena.

4. Adjudication Method (for the test set)

Not applicable. This concept typically refers to clinical studies where independent experts review and agree upon diagnoses or outcomes. For bench testing, the results are objectively measured against established scientific and engineering standards.

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

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical data are included in this submission." This type of study is for clinical evaluations involving human readers and interpretations of medical cases, which is not relevant to this device's non-clinical submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This refers to the performance of AI algorithms. The Klockner Dental Implant Abutments (II) are physical medical devices, not software or AI-based diagnostic tools.

7. The Type of Ground Truth Used

For the non-clinical studies:

Fatigue Testing: The ground truth is derived from engineering standards and physical principles. Specifically, the ISO 14801 standard provides the methodology and criteria for evaluating the fatigue life of dental implants and abutments.
Biocompatibility: The ground truth is established by recognized biocompatibility standards (ISO 10993-1:2009 and ISO 7405:2008) and the known properties of the materials used.
Corrosion Resistance: The ground truth is based on material science and engineering standards (ISO 10993-15, ASTM F746, ASTM G71) for evaluating corrosion and galvanic corrosion.
Sterilization: The ground truth is based on microbiological testing standards (ISO 11737-1, ISO 11737-2, ISO 17665-1) to ensure the device can be effectively sterilized.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.

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

January 29, 2016

SOADCO, S.L. Ms. Maria Mitjaneta Ouality Manager Avgda Fiter I Rosell., 4 Bis-local 2 Escaldes-Engordany, AD-700 ANDORRA

Re: K151194

Trade/Device Name: Klockner Dental Implant Abutments (II) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 16, 2015 Received: December 28, 2015

Dear Ms. Mitianeta:

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 (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 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 -

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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Image /page/2/Picture/1 description: The image shows the logo for SOAD for KLOCKNER. The letters are large and gray, with the word "SOAD" in black. There is a globe image in the middle of the logo. The words "for KLOCKNER" are in a smaller font below the globe.

INDICATIONS FOR USE

510(k) Number (if known):

K151194

Device Name:

Klockner Dental Implant Abutments (II)

Indications for Use:

V Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/1 description: The image shows the logo for SOAD for KLOCKNER. The logo is in black and white and features the letters "SOAD" in a stylized font. The letters are arranged in a slightly overlapping manner. The words "for KLOCKNER" are written in a smaller font below the letters "SOAD". There is a globe image in the middle of the logo.

510(k) SUMMARY K151194

Date of Preparation of Summary: January 25, 2016

Submitter/owner name:	SOADCO, S.L.
Submitter/owner address:	Avgda. Fiter i Rossell, 4bis - Local 2
	ESCALDES - ENGORDANY
	AD-700 (ANDORRA)
Contact person:	Maria Mitjaneta
Phone:	+376 800 590
Fax:	+376 800 594
e-mail:	calidad@soadco.com
Device Trade Name:	Klockner Dental Implant Abutments (II)
Common Name:	Dental Abutments
Classification Name:	Endosseous Dental Implant Abutments
Regulation Number:	21 CFR 872.3630
Class:	Class II
Panel:	Dental
Product code:	NHA

Legally Marketed (Predicate) Device:

PREDICATE DEVICE510(k) Number	Device Trade Name	Manufacturer
K122988	Klockner Dental Implant Abutments	SOADCO S.L.

Device Description:

-Protective cap, made of titanium alloy, intended to be provisionally connected to dental abutment as a protection when choosing direct oral impression on the abutment.
ı Temporary abutment, made of titanium alloy, intended to be provisionally connected to dental abutment to retain a provisional screw-retained multiple-unit restoration.
Angled abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations. These abutments, used when it is necessary to correct prosthesis axis with respect to implant axis, are available with different angulation and different transmucosal height, enabling the anatomic characterization of the gum margin and facilitating the prosthetic fitting.

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Image /page/4/Picture/1 description: The image shows a logo for SOAD for KLOCKNER. The logo is in black and white and features the letters "SOAD" in a stylized font. The letter "O" is replaced by a globe. Below the letters "SOAD" is the text "for KLOCKNER" in a smaller font. The logo is likely for a company or organization called SOAD that is associated with KLOCKNER.

Straight abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations, with not correction of implant angulation. These abutments are available with different transmucosal height, enabling the anatomic characterization of the qum margin and facilitating the prosthetic fitting.
Cast abutments, made of gold alloy and Co-Cr-Mo alloy, intended for cement-retained single- unit and multiple-unit restorations and for screw-retained single-unit restorations on dental implants using the casting technique.

All these abutments are designed for Klockner Dental Implant Systems, models Essential EC (K080224) and Essential EC 1.5 (K082200), with internal octagonal cone connection.

Indications for Use:

The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges. The Klockner Dental Implant Abutments include protective cap, temporary abutments, straight abutments, cast abutments. All abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential EC 1.5.

Summary of Comparison with Predicate Device:

In the establishment of substantial equivalence, Klockner Dental Implant Abutments (II) are compared to a legally marketed device with the same intended use.

Proposed device intended use, indications for use and technological characteristics have been compared with those of predicate device (see next pages), following the guidelines set out in guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

Features of proposed device not shared with predicate device have been substantiated using two reference devices. These differences are not considered to raise different questions of safety and effectiveness than the predicate.

All issues affecting performance have been reviewed and discussed. Any differences have been addressed in the bench testing performed on the proposed device.

REFERENCE DEVICE510(k) Number	Device Trade Name	Manufacturer
K080224	Klockner Essential Dental Implant System	SOADCO S.L.
K121843	NP-Cast Abutment System	OSSTEM Implant Co., Ltd.

NOTE: Numbers noted as 'ref. xx xx xx' (where x means a number) in the table below refer to specific catalog numbers of devices in the Klockner Implant System.

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Image /page/5/Picture/1 description: The image shows the logo for SOADC for Klockner. The logo is in gray and features the letters "SOADC" in a stylized font. The "O" in "SOADC" contains a globe graphic. Below the "C" is the text "for KLOCKNER" in a smaller font.

Features	PROPOSED DEVICE:Klockner Dental Implant Abutments (II)	PREDICATE DEVICE K122988(Klockner Dental Implant Abutments)	REFERENCE DEVICE K080224(Essential Implant System)	REFERENCE DEVICEK121843(NP-Cast Abutment System)
Indicationsfor use	The Klockner Dental Implant Abutments areintended to be placed into dental implants toprovide support for prosthetic reconstructionssuch as crowns, bridges. The Klockner DentalImplant Abutments include protective cap,temporary abutment, angled abutments, straightabutments, cast abutments. All abutments areintended to be used with the Klockner DentalImplant Systems, models: Essential EC, EssentialEC 1.5.	The Klockner Dental Implant Abutments areintended to be placed into dental implants toprovide support for prosthetic reconstructionssuch as crowns, bridges or overdentures. TheKlockner Dental Implant Abutments includehealing caps, protective caps, temporaryabutments, angled abutments, straightabutments, and overdentures. All abutmentsare intended to be used with the KlocknerDental Implant Systems, models: EssentialEC, Essential ES, Essential ECK, EssentialEC 1.5, SK2 and NK2.	The Klockner Essential implant system isespecially designed for surgical insertion intothe bone using additional material to replacethe root of the teeth, acting as the support forthe dental implants formed by implantaccessories.The Essential Solid implants are fitted with aninternal octagonal conical connectioncombined with an external octagonalconnection measuring 1.2 mm in height.The Essential Cone implants are fitted with aninternal octagonal conical connection.The Essential ECK implants are fitted with alarger internal octagonal conical connectionthan that of the Essential Cone implants.Immediate loading is appropriate for theEssential Solid, Essential Cone and EssentialECK implants when good primary stability isachieved with appropriate occlusal loading.Abutments can be used in single toothreplacements and multiple tooth restorations.8mm Implants are not indicated for use asunitary implants and for immediate load.	NP-Cast Abutment System isintended for use with a dentalimplant to provide support forprosthetic restorations such ascrowns, bridges, or overdentures.
Design -Protectiveсар	EC multi-cone protective cap (ref. 10 05 16)Protective cap intended to be provisionallyconnected (contact ≤ 6 months) to 30º and 17ºangular Octacone® multi-cone abutments (ref. 1010 37, 10 10 38, 10 10 43, 10 10 44, 10 10 45)included in this submission, and also to 30ºanqular abutment multi-cone [occlusal screw] (ref10 10 36) cleared in K122988, in order to coverand protect their inner configuration whenchoosing direct oral impression on theseabutments.	Proposed device has the same intended useand is functionally equivalent to thesepredicate devices:EC 12º protective cap (ref. 10 05 14)EC 250 protective cap (ref. 10 05 15)These devices are also connected to dentalabutments in order to cover and protect theirinner configuration when performing directoral impression on them.	N/A	N/A

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Image /page/6/Picture/1 description: The image shows the logo for SOAD for KLOCKNER. The logo is in black and white, and the letters are large and bold. The letter "O" in SOAD has a globe in the middle of it. The words "for KLOCKNER" are in a smaller font below the letter "O".

Features	PROPOSED DEVICE:Klockner Dental Implant Abutments (II)	PREDICATE DEVICE K122988(Klockner Dental Implant Abutments)	REFERENCE DEVICE K080224(Essential Implant System)	REFERENCE DEVICEK121843(NP-Cast Abutment System)
Design -Temporaryabutment	Circular Ti fitting - EC multi-cone (ref. 10 13 16)Abutment intended to be provisionally connected(contact ≤ 6 months) to 30° and 17° angularOctacone® multi-cone abutments (ref. 10 10 37,10 10 38, 10 10 43, 10 10 44, 10 10 45) includedin this submission, and also to 30° angularabutment multi-cone [occlusal screw] (ref. 10 1036) cleared in K122988, for retaining a provisionalscrew-retained multiple-unit restoration whiledefinitive prosthesis is manufactured.	Proposed device has the same intended useand is functionally equivalent to this predicatedevice:Circular Ti Fitting - EC 25° (ref. 10 13 15)This device is also provisionally connected todental abutment to retain a provisional screw-retained multiple-unit restoration whiledefinitive prosthesis is manufactured.	N/A	N/A
Design -Castabutments	Abutments intended for cement-retained single-unit and multiple-unit restorations and for screw-retained single-unit restorations on EssentialCone dental implants, using casting technique.The design consists on a metal-based part with acasting part over-injected in plastic (burned-out incasting process):- G Gold Octacone® abutment (ref. 10 10 13 G):gold cast abutment intended to be connected towide platform Essential Cone implants.- Co-Cr Octacone® abutment (ref. 10 10 16): Co-Cr cast abutment intended to be connected toregular platform Essential Cone implants.- G Co-Cr Octacone® abutment (ref. 10 10 16 G):Co-Cr cast abutment intended to be connectedto wide platform Essential Cone Implants.	N/A	Proposed devices have the same intendeduse and are functionally equivalent toreference device:- Gold Octacone® Abutment (ref. 10 10 13):connected to regular platform EssentialCone implants.This abutment is also intended for cement-retained single-unit and multiple-unitrestorations and for screw-retained single-unitrestorations on Essential Cone dentalimplants, using casting technique.The design also consists on a metal-basedpart with a casting part over-injected in plastic(burned-out in casting process).	N/A

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Image /page/7/Picture/1 description: The image shows the logo for SOADC for Klockner. The logo is in black and white, and the letters are large and bold. The letter "C" in SOADC has a globe inside of it. The words "for Klockner" are in a smaller font size and are located below the "C".

Features	PROPOSED DEVICE:Klockner Dental Implant Abutments (II)	PREDICATE DEVICE K122988(Klockner Dental Implant Abutments)	REFERENCE DEVICE K080224(Essential Implant System)	REFERENCE DEVICEK121843(NP-Cast Abutment System)
Design -Straightabutments	Straight abutments intended to be connected toEssential Cone dental implants (regular platform)for screw-retained multiple-unit restorations, withnot correction of implant angulation.Designed with top conical shape (25° respect tothe implant axis) to make easier the placement ofthe multiple-unit restoration, allowing thecorrection of possible divergences among the axisof the implants involved.Available with different height from implantplatform and different transmucosal height (TH)for enabling the anatomic characterization of thegum margin and facilitating the prosthetic fitting:- 25° Pillar abutment - [2.5 MM] - [TH 1 MM] (ref.10 10 40)- 25° Pillar abutment - [4 MM] - [TH 2.5 MM] (ref.10 10 41)- 25° Pillar abutment - [5.5 MM] - [TH 4 MM] (ref.10 10 42)	Proposed devices have the same intendeduse and are functionally equivalent topredicate device:- 25° pillar abutment - 1mm (ref. 10 10 15)This abutment is also intended to beconnected to Essential Cone dental implantsfor screw-retained multiple-unit restorations,with not correction of implant angulation.It is designed with the same top conical shape(25° respect to the implant axis) as that ofproposed devices, with 1 mm of height fromimplant platform and without transmucosalheight (TH = 0).	N/A	N/A
Design -Angledabutments	Abutments with angulation that modifies theprosthesis axis respect to the implant axis.Intended to be connected to Essential Conedental implants (regular platform) for screw-retained multiple-unit restorations.Available with different angulation (30° and 17°)and different transmucosal height (TH)1 forenabling the anatomic characterization of the gummargin and facilitating the prosthetic fitting:- 30° angular Octacone® multi-cone abutment[TH 4 mm] (ref. 10 10 37)- 30° angular Octacone® multi-cone abutment[TH 5 mm] (ref. 10 10 38)- 17° angular Octacone® multi-cone abutment[TH 2 mm] (ref. 10 10 43)- 17° angular Octacone® multi-cone abutment[TH 3 mm] (ref. 10 10 44)- 17° angular Octacone® multi-cone abutment[TH 4 mm] (ref. 10 10 45)	Proposed devices have the same intendeduse and are functionally equivalent topredicate device:- 30° angular abutment multi-cone [occlusalscrew] (ref. 10 10 36)This abutment is also intended to beconnected to Essential Cone dental implantsand be used for screw-retained multiple-unitrestorations.It is designed with 30° angulation that modifiesthe prosthesis axis respect to the implant axis,and with transmucosal height (TH)1 of 3 mm.	N/A	N/A

් Transmucosal height (TH) is the distance between implant-abutment connection] and prosthetic platform [abutment-prosthesis connection].

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Image /page/8/Picture/1 description: The image is a logo for SOADC for KLOCKNER. The logo is in black and white and features the letters "SOADC" in a stylized font. The "C" in SOADC is a globe. Below the letters is the text "for KLOCKNER" in a smaller font.

Features	PROPOSED DEVICE:Klockner Dental Implant Abutments (II)	PREDICATE DEVICE K122988(Klockner Dental Implant Abutments)	REFERENCE DEVICE K080224(Essential Implant System)	REFERENCE DEVICEK121843(NP-Cast Abutment System)
Material /Composition	- Titanium alloy (ASTM F136, ISO 5832-3): usedin protective cap, temporary abutment, straightabutments and angled abutments.- Gold alloy 6019: used in gold cast abutment.- Co-Cr-Mo alloy (ASTM F1537 alloy 1, ASTMF799, ISO 5832-12): used in Co-Cr castabutments.- POM C: used in casting part of cast abutments(material not intended to be in contact with thepatient, since it is burned-out during the castingprocess of the abutments).	- Titanium alloy (ASTM F136, ISO 5832-3):used in protective caps, temporary abutmentand straight abutment.	- Gold alloy 6019: used in Gold Octacone®Abutment.- POM C: used in casting part of GoldOctacone® Abutment.	- Co-Cr-Mo alloy: used in NP-Cast Abutment System.
Sterility	All devices (protective cap, temporary abutment,cast abutments, straight abutments and angledabutments) are provided non-sterile.These devices are individually packed andprovided non-sterile, but intended to be sterilizedbefore placement in the mouth. Instructions foruse contain the recommended sterilizationprocess validated as per standard ISO 17665-1.	Predicate devices (protective caps, temporaryabutment, straight abutment and angledabutment) are also provided non-sterile.As proposed devices, these predicates areindividually packed and provided non-sterile,but intended to be sterilized before placementin the mouth. The same sterilization process(validated as per ISO 17665-1) isrecommended.	Reference device (cast abutment) is alsoprovided non-sterile.As proposed devices, this reference device isindividually packed and provided non-sterile,but intended to be sterilized before placementin the mouth. The same sterilization process(validated as per ISO 17665-1) isrecommended.	N/A

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Image /page/9/Picture/1 description: The image shows the logo for SOADC for KLOCKNER. The letters SOAD are in black, and the letters C and D are in white with a black outline. The words "for KLOCKNER" are in a smaller font size and are located below the letters C and D. The background of the logo is gray.

Summary Discussion of Non-Clinical Data:

Biocompatibility .
All materials used in the manufacture of Klockner Dental Implant Abutments (II) have been subject to biological evaluation taking account the intended use of the devices and the nature and duration of contact with the patient, according to the requirements of applicable recognized standards ISO 10993-1:2009 and ISO 7405:2008. In the case of Co-Cr cast abutments, the potential degradation of the material in biological environments has also been contemplated; corrosion resistance and galvanic corrosion assays have been carried out according to ISO 10993-15, ASTM F746 and ASTM G71, and test results confirm the high corrosion resistance of Co-Cr-Mo alloy and show an insignificant galvanic corrosion of this material with respect to unalloyed titanium (Ti c.p.) and titanium alloy (Ti-6Al-4V). The materials and manufacturing methods used for the subject device are identical to those

used in the previously cleared devices, and so additional biocompatibility testing was not considered to be necessary to support the substantial equivalence of the subject device.

Sterilization .
Klockner Dental Implant Abutments (II) have been subject to bioburden and sterility testing in accordance with ISO 11737-1 and ISO 11737-2, respectively. Steam sterilization validation according to ISO 17665-1 has been carried out to confirm the sterilization parameters.
. Bench testing
Fatigue testing, conducted according to ISO 14801 and the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, has been performed considering worst-case conditions. Results obtained show that devices performance is acceptable as per their intended use.

Summary Discussion of Clinical Data:

No clinical data are included in this submission.

Conclusions:

We consider that the intended use, the operation principle and the technological characteristics of Klockner Dental Implant Abutments (II) are equivalent to those of predicate devices, although there is a slight difference in the indications for use statement of the subject device compared to the predicate with respect to implant compatibility. There are minor technological differences between the subject and predicate devices. The results of bench testing support the conclusion that risks associated with these technological changes have been adequately mitigated.

Therefore, substantial equivalence of Klockner Dental Implant Abutments (II) to the predicate devices may be established.

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.)