The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType. X-Pert dental implant fixture to aid in prosthetic rehabilitation.

Device Description

PerioType X-Pert Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients. PerioType X-Pert Dental Implant Systems are indicated for delayed loading. The Dental Implant System has an internal octagonal connection between the implant and the abutment. The surface structure of the implant is PerioCoat-R which allows for osseointegration of the implants that is substantially equivalent to the TilUnite surface from Nobel Biocare. The Dental Implants and the abutments are made of Titanium Grade 4. The PerioType X-Pert features an implant-abutment interface with a tapered tight metal fit and an integrated platform switch. The abutments are coated with ZircoSeal™ - a hard coating layer of zirconium nitride. The implants are provided sterile, with sterility achieved by gamma radiation pursuant to ISO 11137.

The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType X-Pert dental implant fixture to aid in prosthetic rehabilitation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PerioType X-Pert dental implant system. This application focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo performance criteria typically seen in clinical trials for new medical devices.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical performance study with specific endpoints and ground truth determinations, as might be expected for an AI/ML device, does not directly apply here. Instead, the study's goal is to show that the new device is as safe and effective as existing legally marketed predicate devices.

The document highlights the PerioType X-Pert's characteristics and compares them to predicate devices, primarily the Nobel Biocare NOBELSPEEDY Implants (K050406) for the implant and Nobel Estehtik Abutments (K111581) and other Branemark System abutments for the abutments.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission, the "acceptance criteria" are not explicit performance metrics for the device itself against a clinical gold standard. Instead, the acceptance criteria are implicit in demonstrating that the new device is as safe and effective as the predicate devices. The "reported device performance" is primarily a comparison of materials, design, intended use, and mechanical testing results to assert this equivalence.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Intended Use: Similar to predicate device.	PerioType X-Pert Implants have the same intended use as NOBELSPEEDY Implants (K050406): threaded, root-form dental implants for upper/lower jaw to support prosthetic devices to restore aesthetics/chewing function in edentulous patients. PerioType X-Pert Abutments are for prosthetic rehabilitation with PerioType X-Pert dental implant fixtures, similar to predicate abutments.
Technological Characteristics: Similar materials, design principles, sterility methods, and mechanical performance as predicate device.	Material: Both PerioType X-Pert implants and abutments (base material) are made of Titanium Grade 4, identical to the predicate implant and abutment. Surface Coating (Implant): PerioCoat-R is demonstrated to be equivalent to the TilUnite surface of the predicate device based on morphological and chemical viewpoints by "Meyer&Horn-Salmondelkin Gbr" laboratory. Surface Coating (Abutment): Abutments are coated with ZircoSeal™ (zirconium nitride). This is a difference from the predicate device but is addressed by conducting testing based on the Guidance of Modified surfaces. Design (Implant): Threaded (self-tapping, tapered apical end), root-form, internal octagonal connection, micro groove with reduced thread pitch. Similar to predicate (Nobel Biocare NOBELSPEEDY Implant has an internal hexagon connection and tri channel design, but overall form and thread characteristics are stated as similar). Design (Abutment): Straight, angled, and ball abutments with various gingiva heights and diameters. Similar to predicate abutments. Sterility: Devices are sold gamma sterilized (implants) or not sterilized (abutments), similar to predicate practices. Biocompatibility: Products comply with ISO 7405, similar to predicate device.
Mechanical Safety/Performance: Mechanical testing demonstrates comparable safety and effectiveness to predicate device.	"We conducted mechanical tests to support the substantial equivalence... Fatigue tests according to the FDA Guidance as appendix A22-A25. Conclusion: The test results shows that PerioType X Pert Implants are as Safe and effektiv as the predicate device."

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

Implants: The document mentions "direct comparative test between the device and the predicate device" for the surface coating and "mechanical tests" and "Endolab Fatigue test for endosseus dental implants in accordance with the ISO 14801" for performance.
- The sample size for these tests is not explicitly stated in the provided text (e.g., number of implant samples tested for fatigue). It only refers to appendices (A22-A25 for fatigue, A42 for surface coating).
- Data Provenance: The tests appear to be conducted by the manufacturer or their designated testing facilities (e.g., "Meyer&Horn-Salmondelkin Gbr" laboratory for surface, "Endolab" for fatigue). The nature of the tests (mechanical, chemical, morphological) implies a retrospective laboratory testing environment rather than a prospective clinical study involving human patients. The country of origin for the testing is not specified, though the manufacturer is in Switzerland.
Abutments: Mention of tests "quested by the Guidance of Modified surfaces" and biocompatibility testing to ISO 7405. No specific sample sizes for these tests are provided.

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

For a 510(k) submission based on substantial equivalence and mechanical testing, the concept of "ground truth" established by experts in a clinical context (like radiologists for image analysis) is not directly applicable.

For the surface coating comparison, the "Meyer&Horn-Salmondelkin Gbr" laboratory is mentioned as having judged "morphological and chemical view points." The specific number and qualifications of the experts within this laboratory are not detailed in the provided text.
For mechanical testing (fatigue), the "Endolab" entity is mentioned. Again, the specific number and qualifications of experts overseeing or performing these tests are not provided.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies involving interpretation of data (e.g., medical images, pathology slides) by multiple human readers, which is not the type of study described here. The studies involve laboratory-based comparisons and mechanical testing.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance on various cases, which is irrelevant for a submission concerning dental implants where the primary goal is substantial equivalence through material properties and mechanical performance.

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

No, a standalone (algorithm-only) performance study was not done. This device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established through laboratory-based analytical and mechanical testing methodologies, comparing the new device's properties directly against those of the predicate device.

Material Composition: Chemical analysis and material specifications (Titanium Grade 4).
Surface Morphology/Chemistry: Morphological and chemical examinations performed by the "Meyer&Horn-Salmondelkin Gbr" laboratory.
Biocompatibility: Conformance to ISO 7405 standards.
Mechanical Performance: Fatigue testing according to ISO 14801.

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI/ML device, there is no "training set" in the sense of data used to train an algorithm. The testing described focuses on evaluating the physical and mechanical properties of the device.

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

Not applicable for the same reason as above.

Summary

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1123386

	PerioType X-PertPremarket Notification / 510(k) Submission	Page 1 of 15
	510(k) Summary

5 510(k) Summary of Safety and Effectiveness

APR 2 6 2013

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Tab. 1: Information regarding new device

Manufacturer name:	Clinical House Europe GmbH
Manufacturer address:	Opfikonerstrasse 108303 BassersdorfSwitzerland
Telephone number:	+49 234 974760-26
Fax number:	+49 234 974760-30
Official contact:	Mrs Ulrike Kuckelkorn
Date the summary was prepared:	February 5, 2013
Device trade name:	PerioType X-Pert
Device common name:	PerioType X-Pert
Device classification:	Implant Endosseous, root-formProduct code DZE21 CFR 872.3640Endosseous dental implant abutmentProduct code NHA21 CFR 872.3630
Establishment Registration Number	TBD
Predicate Device for the implant:	Nobel Biocare USA LLCNOBELSPEEDY IMPLANTSK050406
Predicate Device for abutment:	Nobel Estehtik AbutmentsK111581Branemark System 17° angulatedK944962Branemark System Ball AttachmentAbutment SystK920452Branemark System Titanium Healing

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Kf0-œ	くﺎ	086ﻟﻠ
-----------------------	--------	---------------

Image	PerioType X-PertPremarket Notification / 510(k) Submission510(k) Summary	Page 2 of 15
	AbutmentsK035770

Intended Use:

The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType. X-Pert dental implant fixture to aid in prosthetic rehabilitation.

Device Description:

The modification of the Implants are presented in the table below:

PerioType X-Pert Ø 3.5 mm (incl. Cover Screw)

XPSS3508	Ø 3.5 x 8.5 mm L
XPSS3510	Ø 3.5 x 10.0 mm L
XPSS3511	Ø 3.5 x 11.5 mm L
XPSS3513	Ø 3.5 x 13.0 mm L
XPSS3515	Ø 3.5 x 15.0 mm L
XPCSS350	Cover Screw for PerioType X-Pert Ø 3.5 mm

PerioType X-Pert Ø 4.1 mm (incl. Cover Screw)

Image: Screw	XPS4108	Ø 4.1 x 8.5 mm L
	XPS4110	Ø 4.1 x 10.0 mm L
	XPS4111	Ø 4.1 x 11.5 mm L
	XPS4113	Ø 4.1 x 13.0 mm L
	XPS4115	Ø 4.1 x 15.0 mm L
	XPCS410	Cover Screw for PerioType X-Pert Ø 4.1 mm

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Image: Logo	PerioType X-PertPremarket Notification / 510(k) Submission510(k) Summary	Page 3 of 15
	PerioType X-Pert Ø 5.0 mm (incl. Cover Screw)

XPS5008	Ø 5.0 x 8.5 mm L
XPS5010	Ø 5.0 x 10.0 mm L
XPS5011	Ø 5.0 x 11.5 mm L
XPS5013	Ø 5.0 x 13.0 mm L
XPS5015	Ø 5.0 x 15.0 mm L
XPCS500	Cover Screw for PerioType X-Pert Ø 5.0 mm

The Dental Implant System has an internal octagonal connection between the implant and the abutment. The surface structure of the implant is PerioCoat-R which allows for osseointegration of the implants that is substantially equivalent to the TilUnite surface from Nobel Biocare. We demonstrate the Equivalenz to the surface of the predicate device as by a direct comparative test between the device and the predicate device

Conclusion : In both cases the same coating layer was found when judged by morphological and chemical view points by the "Meyer&Horn-Salmondelkin Gbr" laboratory. They demonstrate the Equivalenz to the surface of the predicate device through a morphiolgial and chemical examination by comparison

The test demonstrate the effectiviness and safety of the device due to the Guidance AMTI 1854

We attached the report as A42

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3 × 7 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1	PerioType X-PertPremarket Notification / 510(k) Submission	Page 4 of 15
(1) == == ====================================================================================================================================================================	510(k) Summary

The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType X-Pert dental implant fixture to aid in prosthetic rehabilitation.

ZircoSeal Abutments straight - 0° for Implants Ø 3.5 mm (incl. Abutment screw) 0° - P Ø 3.9 x 1.0 mm GH NASS390010 0° - P Ø 3.9 x 2.0 mm GH

NASS390020 0° - P Ø 3.9 x 3.0 mm GH NASS390030

ZircoSeal Abutments straight - 0° for Implants Ø 4.1 / 5.0 mm (incl. Abutment screw)

0° - P Ø 4.2 x 1.0 mm GH NAS420010 0° - P Ø 4.2 x 2.0 mm GH NAS420020 NAS420030 i 0° - P Ø 4.2 x 3.0 mm GH 0° - P Ø 4.2 x 4.0 mm GH NAS420040

ZircoSeal Abutments straight - 0° for Implants Ø 4.1 / 5.0 mm (Incl. Abutment screw)

NAS550010	0°-P Ø 5.5 x 1.0 mm GH
NAS550020	0°- P Ø 5.5 x 2.0 mm GH
NAS550030	0° - P Ø 5.5 x 3.0 mm GH
NAS550040	0°-P Ø 5.5 x 4.0 mm GH

ZircoSeal Abutments angled - 15° for Implants Ø 3.5 mm (incl. Abutment screw) NAAS391510 15° - P Ø 3.9 x 1.0 - 2.0 mm GH

NAAS391520 15° - P Ø 3.9 x 2.0 - 3.0 mm GH

ZircoSeal Abutments angled - 15° for Implants Ø 4.1 / 5.0 mm (incl. Abutment screw)

NAA421510	15°-P Ø 4.2 x 1.0-2.0 mm GH
NAA421520	15°-P Ø 4.2 x 2.0 - 3.0 mm GH
NAA421530	15°-P Ø 4.2 x 3.0 - 4.0 mm GH

ZircoSeal Abutments angled - 15° for Implants Ø 4.1 / 5.0 mm (incl. Abutment screw)

NAA551510	15° - P Ø 5.5 x 1.0 - 2.0 mm GH
NAA551520	15° - P Ø 5.5 x 2.0 - 3.0 mm GH
NAA551530	15° - P Ø 5.5 x 3.0 - 4.0 mm GH

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K123386

		PerioType X-PertPremarket Notification / 510(k) Submission510(k) Summary
ZircoSeal Ball Abutments for Implants Ø 3.5 mm(without matrice)
	BAS2520	2.0 mm GH - Ball Diameter 2.25 mm
	BAS2540	4.0 mm GH - Ball Diameter 2.25 mm
	BAS2560	6.0 mm GH - Ball Diameter 2.25 mm
ZircoSeal Ball Abutments for Implants Ø 4.1 / 5.0 mm(without matrice)
	BA2520	2.0 mm GH - Ball Diameter 2.25 mm
	BA2540	4.0 mm GH - Ball Diameter 2.25 mm
	BA2560	6.0 mm GH - Ball Diameter 2.25 mm
ZircoSeal Milling Cylinder for Implants Ø 4.1 / 5.0 mm(incl. Abutment screw)
	MC750	Ø 7.5 x 10.0 mm H
ZircoSeal Healing Abutments P Ø 4.5 mm for Implants Ø 3.5 mm
	PHAOPS4520	Ø 4.5 x 2.0 mm GH
	PHAOPS4540	Ø 4.5 x 4.0 mm GH
	PHAOPS4560	Ø 4.5 x 6.0 mm GH
ZircoSeal Healing Abutments P Ø 5.2 mm for Implants Ø 4.1 / 5.0 mm
	PHAOP5220	Ø 5.2 x 2.0 mm GH
	PHAOP5240	Ø 5.2 x 4.0 mm GH
	PHAOP5260	Ø 5.2 x 6.0 mm GH
ZircoSeal Healing Abutments P Ø 6.5 mm for Implants Ø 4.1 / 5.0 mm
	PHAOP6520	Ø 6.5 x 2.0 mm GH
	PHAOP6540	Ø 6.5 x 4.0 mm GH

The Dental Implants and the abutments are made of Titanium Grade 4 like the Predicate Device.

The PerioType X-Pert features an implant-abutment interface with a tapered tight metal fit and an integrated platform switch. The abutments are coated with ZircoSeal™ - a hard coating layer of zirconium nitride. The implants are provided sterile, with sterility achieved by gamma radiation pursuant to ISO 11137.

Zirco Seal is the tradename of a Zirkoniumnitride coating which is used only on the abutments . ZircoSeal has been used since many years in the dentalmarket. There is no predicate device to Zirco Seal. To show the Safety and effectiviness we conducted all the testing quested by the Guidance of Modified surfaces.

Theres are attached as A29-A38 and A 45-46

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123386

	PerioType X-Pert
	Premarket Notification / 510(k) Submission	Page 6 of 15
	510(k) Summary

Revision 0.0

. .

Date 2012-10-22

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Image: Logo	PerioType X-PertPremarket Notification / 510(k) Submission510(k) Summary	Page 7 of 15
-------------	----------------------------------------------------------------------------------	--------------

Equivalence to Marketed Device:

The PerioType X-Pert is substantially equivalent to the NOBEL SPEEDY™ Implants (K050406). The candidate device and the predicate device have the same intended use, are both made of pure titanium, have similar technological characteristics, and the coatings of the implant bodies are equivalent. Both candidate and predicate device are sold in similar sizes, packed similarly, and are sterilized identically.

Summary of similaritis and modification between the devics which are subject of this 510(k) and predicate device is presented in the table below.

Element ofcomparison	PerioType X-Pert-new device-	NOBELSPEEDY IMPLANTSK050406-predicate device-
	Image: PerioType X-Pert Implant	Image: Nobel Biocare's NOBELSPEEDY Implant
Devicedescription	PerioType X-Pert Implants are threaded,root-form dental implants intended foruse in the upper and lower jaw to supportprosthetic devices, such as artificialteeth, in order to restore aesthetics andchewing function to partially or fullyedentulous patients. PerioType X-PertDental Implant Systems are indicated fordelayed loading.	Nobel Biocare's NOBELSPEEDYTM-Implants are threaded, root-form dentalimplants intended for use In the upperand lower jaw to support prostheticdevices, such as artificial teeth, in orderto restore aesthetics and chewingfunction to partially or fully edentulouspatients

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Image: [logo]	PerioType X-PertPremarket Notification / 510(k) Submission510(k) Summary		Page 8 of 15
Element ofcomparison	PerioType X-Pert-new device-	NOBELSPEEDY IMPLANTSK050406-predicate device-
Indication	PerioType X-Pert Implants arethreaded,root-form dental implantsintended for use in the upper jaw andlower jaw to support prosthetic devices,such as artificial teeth, in order to restoreaesthetics and chewing function to thepatients.	NOBELSPEEDY- ™ Implants are root-form endosseous implants intended to besurgically placed in the bone of the upperor lower jaw arches to provide support forprosthetic devices, such as an artificialtooth, in order to restore patient estheticsand chewing function.Nobel Biocare's NOBELSPEEDY- ™Implants are indicated for single ormultiple unit restorations in splinted ornon-splinted applications.NOBELSPEEDY- ™ Implants may beplaced immediately and put intoImmediate function providing that theinitial stability requirements detailed inthe surgical manuals are satisfied.NOBELSPEEDY- ™ - Implants areindicated for use in soft bone orwhenever immediate or early loading isapplied. The NOBELSPEEDY- ™Implants incorporate a groove on theimplant thread and are preferred
		over models without the groove in thesesoft bone indications because boneforms more rapidly in the groove than onother parts of the implant resulting inincreased stability when compared tonon-grooved implants. In addition, theNOBELSPEEDY-™ Implants arepreferred in these soft bone indicationsbecause bone formation on the TiUnite®surface is more rapid and greater than onmachined surface implants resulting inbetter maintenance of initial Implantstability, faster and strongerosseointegration, and higher successrates.NOBELSPEEDY- ™ Implants may betilted up to 45°. When used withangulations between 30° and 45° aminimum of four implants must be usedand splinted.
Anatomicalsites	Upper and lower jaw		Upper and lower jaw
design	Endosseous implant, root form,Cylindrical shape	Endosseous implant, root formCylindrical shape

Date 2012-10-22

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Element ofcomparison	PerioType X-Pert-new device-	NOBELSPEEDY IMPLANTSK050406-predicate device-
ImplantProsthesisinterface	Internal octagon connection	Internal hexagon connectionTri channel design
Implant neck	Micro Groove with reduced thread pitchin the crestal area of the implant	Micro Groove with reduced thread pitchin the crestal area of the implant
Thread	Self taping thread with slightly taperedapical end	Self taping thread with slightly taperedapical end
Surface:	Modified Titanium surface	Modified Titanium surface
Materials	The implants are made of pure Titaniumgrade 4	The Implants are made of pure Titaniumgrade 4
Biocompatibility:	The products comply with the ISO 7405,We state references to this in chapter 15	The products comply with the ISO 7405,We state references to this in chapter 15
Sterility:	Devices are sold gamma sterilized	Devices are sold gamma sterilized
Mechanicalsafety:	Endolab Fatigue test for endosseusdental implants in accordance with theISO 14801 as reported below	Endolab Fatigue test for endosseusdental implant in accordance with theISO 14801 as reported below

Performance Characteristics:

We conducted mechanical tests to support the substantial equivalence of the PerioType X-Pert Implant System to the Nobel Biocare Nobelspeedy Implants (K050406):

We attached the results of the Fatigue tests according to the FDA Guidance as appendix A22-A25

Conclusion: The test results shows that PerioType X Pert Implants are as Safe and effektiv as the predicate device.

Revision 0.0

Date 2012-10-22

-1

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PerioType X-PertPremarket Notification / 510(k) Submission510(k) Summary
Page 10 of 15

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PerioType X-Pert
Premarket Notification / 510(k) Submission
510(k) Summary

Page 11 of 15
---------------

As underlined by the comparison table below, the PerioType X-Pert abutments of this device can be concluded to be substantial equivalent to the predicate device:

Element ofcomparison	PerioTypeX-PertZircoSeal Abutment straight	Nobel Estehtik AbutmentsK111581
	-new device-	-predicate device-
Function:	Directly connected to the Implant and used as prosthetic device for cementedrestauration for crown or bridgework.
Height:	Available for different thickness ofGingiva:1 mm2 mm3 mm and4 mm	Available for different thickness ofGingiva:1mm2mm3mm
Diameter:	ZircoSeal Abutment are produced in 3diameters:3,54.15.0 for the different diameters of theImplants	Nobel Estehtik Abutments are producedfor 3 diameters of Implants:rp=3,3-3,5np=4,0wp=5,0
	The diameter of the abutment is adjusted to each Implant diameters
Use:	single use	single use
Material:	titanium coated with ZircoSeal	Titanium
Biocompatibility:	Biocompatibiliy was tested to ISO 7405
Sterility:	Devices are not sterilized	Devices are not sterilized
Conclusion:	The PerioType X-Pert abutment straight is equivalent to the predicate devicebecause they are made from the same material and they have got the samefunction. The only differences is that the device is coated with Zirconiumnitride.

・

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	PerioType X-PertPremarket Notification / 610(k) Submission510(k) Summary	Page 12 of 15
Element ofcomparison	ZircoSeal Abutment angulateal-new device-	Branemark System 17° angulatedK944962
Function:	directly connected to the Implant and used as an prosthetic devia for cementealrestaurations for crown or bridgework
Height:	available for 3 different Gingiva heights:1mm-2mm2mm-3mm3mm-4mm	Available differant Gingiva heigts:1mm-2mm2mm-3mm3mm-4mm
Diameter:	ZircoSeal Abutment are produced in 3diameters:3,54.15.0 for the different diameters of theImplants	Nobel Estehtik Abutments areproduced for 3 diameters of Implants:rp=3,3-3,5np=4,0wp=5,0
Use:	singel use	singel use
Material:	titanium coated with ZircoSeal	titanium
Biocompatibility:	Biocompatibiliy was tested to ISO 7405
Sterility:	Devices are not sterilized	Devices are not sterilized
Conclusion:	The PerioType X-Pert Abutment angulateal is equivalent to the predicate devicebecause they are made from the same material and they have got the samefunction. The only differences is that the device is coated with Zirconiumnitrid.

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	PerioType X-PertPremarket Notification / 510(k) Submission510(k) Summary
Element ofcomparison	Periotype Ballatachment-new device-	Branemark System BallAttachment Abutment SystK920452
Function:	The device is an aid for the fixation ofremovable prosthecis	The device is an aid for the fixationof removable prosthecis
Heigt:	The device is produced for different heigtof Gingiva2mm4mm6mm	The device is produced fordifferent heigt of Gingiva1mm3mm5mm
Diameter:	Diameter:3,54,15,0	Diameter:3,54,15,0
Use:	single use	singel use
Biocompatibility:	Biocompatibiliy was tested to ISO 7405
Sterility:	Devices are not sterilized	Devices are not sterilized
Material:	titanium coated with ZircoSeal	titanium
Conclusion:	The PerioType X-Pert Ballattachment abutment is equivalent to the predicatedevice because they are made from the same material and they have got thesame function. The only differences is that the device is coated withZirconiumnitrid.

、

..............................................................................................................................................................................

: .

: ·

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PerioType X-PertPremarket Notification / 510(k) Submission510(k) Summary		Page 14 of 15
Element ofcomparison	PerioType Healing Abutment-new device-	Branemark System TitaniumHealing AbutmentsK925779
	are an surgigal aid for the healing of thegingiva when placing implantssübmerged or semi submerged
	Diameter:4,5 for 3,5mm Implants5,2 for 4,1 and 5,0 mm Implants6,5 for 4,1 and 5,0 mm Implants	Diameter:3,5mm and 4,5mm for 3,5mmImplants4,0mm and 5,0mm for 4,0mmImplants5,0mm and 6,0mm for 5,0mmImplants
Use:	single use	singel use
Biocompatibility:	Biocompatibiliy was tested to ISO 7405
Sterility:	Devices are not sterilized	Devices are not sterilized
Material:	titanium coated with ZircoSeal	titanium
Summary:	The Clinical House Europe healingabutment are similar as the pridicatedevice and made for the sameindication.
Conclusion:	The PerioType X-Pert Healing abutment is equivalent to the predicate devicebecause they are made from the same material and they have got the samefunction. The only differences is that the device is coated with Zirconiumnitrid.

Madell

ుండు 11
ఇంటరాలు, ఇకా వ్యాస్యం కొంగురు, బి. బి. బి. బాలలు విద్యాలయం
సంఖ్య 44 డిస్తరించి విద్యాలయం 17 హెక్టార్లు 44 22010-69
సంస్థ 14 44 డవలకంటేంది. శిశు 144 44 44 44 22010

. · Date 2012-10-22

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123386

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :	PerioType X-PertPremarket Notification / 510(k) Submission	Page 15 of 15
1977 28 24 21 1 23 18 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11	510(k) Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/15/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.

Public Health Service

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

April 26, 2013

Clinical House Europe GmbH C/O Dr. Judith Weissinger Weissinger Solutions, Inc. 9360-West-Flamingo-Road-Suite #1-10=553-LAS VEGAS NV 89147

Re: K123386

Trade/Device Name: PerioType X-Pert Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 26, 2013 Received: March 27, 2013

Dear Dr. Weissinger:

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 – Mrs. Kuckelkorn

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections-531-542-of the Act);-21-CFR-1000-1050;-

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,

Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
Sasan Runner, DDS,MAcn=Mary S. Runner -S,
0.9.2342.19200300.100.1.1=13000879
50
Date: 2013.04.26 08:59:36 -04'00'

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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	PerioType X-Pert	Page 19 of 886
	Premarket Notification / 510(k) Submission
	510(k) Summary
CLESDA SE OP

Indications for Use Statement 4

Indications for Use

510(k) Number (if known):_KL23 38

Device Name: PerioType X-Pert

The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType X-Pert dental implant fixture to aid in prosthetic rehabilitation.

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page_1_of_1_

Revision 0.0

Runner -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
Susan Runner, DOS, MA cn=Mary S. Runner -S,
0.9.2342.19200300.100.1.1=1300
087950
(Division Sign-Off) Date: 2013.04.25 11:38:35 -04'00'

(Division of Anesthasiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Date 2012-10-22

Digitally signed by Mary S.

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.