PERIOTYPE X-PERT
Device Facts
| Record ID | K123386 |
|---|---|
| Device Name | PERIOTYPE X-PERT |
| Applicant | Clinical House Europe GmbH |
| Product Code | DZE · Dental |
| Decision Date | Apr 26, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
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 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 Story
PerioType X-Pert is a threaded, root-form dental implant system used to support prosthetic devices (artificial teeth) in the upper or lower jaw. The system includes titanium implants and various abutments (straight, angled, ball, healing). Implants feature an internal octagonal connection and a PerioCoat-R surface; abutments feature a ZircoSeal (zirconium nitride) coating. The device is used by dental professionals in a clinical setting to restore aesthetics and chewing function. Implants are provided sterile via gamma radiation; abutments are non-sterile. The system is designed for delayed loading. Clinical benefit is achieved through osseointegration, providing a stable foundation for prosthetic rehabilitation.
Clinical Evidence
Bench testing only. Fatigue testing was performed in accordance with ISO 14801. Surface equivalence to the predicate was demonstrated via comparative morphological and chemical examination by an independent laboratory. Biocompatibility testing was conducted per ISO 7405.
Technological Characteristics
Materials: Titanium Grade 4. Surface: PerioCoat-R (implant), ZircoSeal (zirconium nitride coating on abutments). Connection: Internal octagonal. Sterilization: Gamma radiation (implants per ISO 11137). Form factor: Threaded, root-form. Standards: ISO 14801 (fatigue), ISO 7405 (biocompatibility).
Indications for Use
Indicated for partially or fully edentulous patients requiring prosthetic rehabilitation in the upper or lower jaw. Implants are indicated for delayed loading. Abutments are indicated for use with the implant fixture to support prosthetic devices.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- NOBELSPEEDY IMPLANTS (K050406)
- Nobel Estehtik Abutments (K111581)
- Branemark System 17° angulated (K944962)
- Branemark System Ball Attachment Abutment Syst (K920452)
- Branemark System Titanium Healing Abutments (K035770)
Related Devices
- K182908 — Ziacom Dental Implant Systems · Ziacom Medical, S.L. · Jul 18, 2019
- K133510 — NEODENT IMPLANT SYSTEM · Jj Industria E Comercio DE Materiais Dentarios SA · Feb 24, 2014
- K170372 — SpiralTech Dental Implant System · Spiraltech Superior Dental Implants, Inc. · Jun 30, 2017
- K061500 — SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS · Sic Invent AG · Aug 8, 2006
- K222457 — Provata Implant System · Southern Implants (Pty), Ltd. · Mar 6, 2023
Submission Summary (Full Text)
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1123386
| | PerioType X-Pert<br>Premarket 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 10<br>8303 Bassersdorf<br>Switzerland |
| 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-form<br>Product code DZE<br>21 CFR 872.3640<br>Endosseous dental implant abutment<br>Product code NHA<br>21 CFR 872.3630 |
| Establishment Registration Number | TBD |
| Predicate Device for the implant: | Nobel Biocare USA LLC<br>NOBELSPEEDY IMPLANTS<br>K050406 |
| Predicate Device for abutment: | Nobel Estehtik Abutments<br>K111581<br>Branemark System 17° angulated<br>K944962<br>Branemark System Ball Attachment<br>Abutment Syst<br>K920452<br>Branemark System Titanium Healing |
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| K<br>f<br>0<br>-<br>œ | く<br>ﺎ | 0<br>86<br>ﻟﻠ |
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| Image | PerioType X-Pert<br>Premarket Notification / 510(k) Submission<br>510(k) Summary | Page 2 of 15 |
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| | Abutments<br>K035770 | |
#### Intended Use:
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 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 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-Pert<br>Premarket Notification / 510(k) Submission<br>510(k) Summary | Page 3 of 15 |
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| | 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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| (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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| | | PerioType X-Pert<br>Premarket Notification / 510(k) Submission<br>510(k) Summary | Page 5 of 15 |
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| ZircoSeal Ball Abutments for Implants Ø 3.5 mm<br>(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<br>(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<br>(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
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| | 510(k) Summary | |
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### 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 of<br>comparison | PerioType X-Pert<br>-new device- | NOBELSPEEDY IMPLANTS<br>K050406<br>-predicate device- |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Image: PerioType X-Pert Implant | Image: Nobel Biocare's NOBELSPEEDY Implant |
| Device<br>description | PerioType X-Pert Implants are threaded,<br>root-form dental implants intended for<br>use in the upper and lower jaw to support<br>prosthetic devices, such as artificial<br>teeth, in order to restore aesthetics and<br>chewing function to partially or fully<br>edentulous patients. PerioType X-Pert<br>Dental Implant Systems are indicated for<br>delayed loading. | Nobel Biocare's NOBELSPEEDYTM-<br>Implants are threaded, root-form dental<br>implants intended for use In the upper<br>and lower jaw to support prosthetic<br>devices, such as artificial teeth, in order<br>to restore aesthetics and chewing<br>function to partially or fully edentulous<br>patients |
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| Element of<br>comparison | | PerioType X-Pert<br>-new device- | NOBELSPEEDY IMPLANTS<br>K050406<br>-predicate device- | | |
| Indication | | PerioType X-Pert Implants are<br>threaded,root-form dental implants<br>intended for use in the upper jaw and<br>lower jaw to support prosthetic devices,<br>such as artificial teeth, in order to restore<br>aesthetics and chewing function to the<br>patients. | NOBELSPEEDY- ™ Implants are root-<br>form endosseous implants intended to be<br>surgically placed in the bone of the upper<br>or lower jaw arches to provide support for<br>prosthetic devices, such as an artificial<br>tooth, in order to restore patient esthetics<br>and chewing function.<br>Nobel Biocare's NOBELSPEEDY- ™<br>Implants are indicated for single or<br>multiple unit restorations in splinted or<br>non-splinted applications.<br>NOBELSPEEDY- ™ Implants may be<br>placed immediately and put into<br>Immediate function providing that the<br>initial stability requirements detailed in<br>the surgical manuals are satisfied.<br>NOBELSPEEDY- ™ - Implants are<br>indicated for use in soft bone or<br>whenever immediate or early loading is<br>applied. The NOBELSPEEDY- ™<br>Implants incorporate a groove on the<br>implant thread and are preferred | | |
| | | | over models without the groove in these<br>soft bone indications because bone<br>forms more rapidly in the groove than on<br>other parts of the implant resulting in<br>increased stability when compared to<br>non-grooved implants. In addition, the<br>NOBELSPEEDY-™ Implants are<br>preferred in these soft bone indications<br>because bone formation on the TiUnite®<br>surface is more rapid and greater than on<br>machined surface implants resulting in<br>better maintenance of initial Implant<br>stability, faster and stronger<br>osseointegration, and higher success<br>rates.<br>NOBELSPEEDY- ™ Implants may be<br>tilted up to 45°. When used with<br>angulations between 30° and 45° a<br>minimum of four implants must be used<br>and splinted. | | |
| Anatomical<br>sites | | Upper and lower jaw | | Upper and lower jaw | |
| design | | Endosseous implant, root form,<br>Cylindrical shape | Endosseous implant, root form<br>Cylindrical shape | | |
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| Element of<br>comparison | PerioType X-Pert<br>-new device- | NOBELSPEEDY IMPLANTS<br>K050406<br>-predicate device- |
|------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Implant<br>Prosthesis<br>interface | Internal octagon connection | Internal hexagon connection<br>Tri channel design |
| Implant neck | Micro Groove with reduced thread pitch<br>in the crestal area of the implant | Micro Groove with reduced thread pitch<br>in the crestal area of the implant |
| Thread | Self taping thread with slightly tapered<br>apical end | Self taping thread with slightly tapered<br>apical end |
| Surface: | Modified Titanium surface | Modified Titanium surface |
| Materials | The implants are made of pure Titanium<br>grade 4 | The Implants are made of pure Titanium<br>grade 4 |
| Biocompatibilit<br>y: | The products comply with the ISO 7405,<br>We state references to this in chapter 15 | The products comply with the ISO 7405,<br>We state references to this in chapter 15 |
| Sterility: | Devices are sold gamma sterilized | Devices are sold gamma sterilized |
| Mechanical<br>safety: | Endolab Fatigue test for endosseus<br>dental implants in accordance with the<br>ISO 14801 as reported below | Endolab Fatigue test for endosseus<br>dental implant in accordance with the<br>ISO 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.
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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 of<br>comparison | PerioTypeX-Pert<br>ZircoSeal Abutment straight | Nobel Estehtik Abutments<br>K111581 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| | -new device- | -predicate device- |
| Function: | Directly connected to the Implant and used as prosthetic device for cemented<br>restauration for crown or bridgework. | |
| Height: | Available for different thickness of<br>Gingiva:<br>1 mm<br>2 mm<br>3 mm and<br>4 mm | Available for different thickness of<br>Gingiva:<br>1mm<br>2mm<br>3mm |
| Diameter: | ZircoSeal Abutment are produced in 3<br>diameters:<br>3,5<br>4.1<br>5.0 for the different diameters of the<br>Implants | Nobel Estehtik Abutments are produced<br>for 3 diameters of Implants:<br>rp=3,3-3,5<br>np=4,0<br>wp=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 device<br>because they are made from the same material and they have got the same<br>function. The only differences is that the device is coated with Zirconiumnitride. | |
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| Element of<br>comparison | ZircoSeal Abutment angulateal<br>-new device- | Branemark System 17° angulated<br>K944962 |
| Function: | directly connected to the Implant and used as an prosthetic devia for cementeal<br>restaurations for crown or bridgework | |
| Height: | available for 3 different Gingiva heights:<br>1mm-2mm<br>2mm-3mm<br>3mm-4mm | Available differant Gingiva heigts:<br>1mm-2mm<br>2mm-3mm<br>3mm-4mm |
| Diameter: | ZircoSeal Abutment are produced in 3<br>diameters:<br>3,5<br>4.1<br>5.0 for the different diameters of the<br>Implants | Nobel Estehtik Abutments are<br>produced for 3 diameters of Implants:<br>rp=3,3-3,5<br>np=4,0<br>wp=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 device<br>because they are made from the same material and they have got the same<br>function. The only differences is that the device is coated with Zirconiumnitrid. | |
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| Element of<br>comparison | Periotype Ballatachment<br>-new device- | Branemark System Ball<br>Attachment Abutment Syst<br>K920452 | |
| Function: | The device is an aid for the fixation of<br>removable prosthecis | The device is an aid for the fixation<br>of removable prosthecis | |
| Heigt: | The device is produced for different heigt<br>of Gingiva<br>2mm<br>4mm<br>6mm | The device is produced for<br>different heigt of Gingiva<br>1mm<br>3mm<br>5mm | |
| Diameter: | Diameter:<br>3,5<br>4,1<br>5,0 | Diameter:<br>3,5<br>4,1<br>5,0 | |
| 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 predicate<br>device because they are made from the same material and they have got the<br>same function. The only differences is that the device is coated with<br>Zirconiumnitrid. | | |
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| Element of<br>comparison | PerioType Healing Abutment<br>-new device- | Branemark System Titanium<br>Healing Abutments<br>K925779 |
| | are an surgigal aid for the healing of the<br>gingiva when placing implants<br>sübmerged or semi submerged | |
| | Diameter:<br>4,5 for 3,5mm Implants<br>5,2 for 4,1 and 5,0 mm Implants<br>6,5 for 4,1 and 5,0 mm Implants | Diameter:<br>3,5mm and 4,5mm for 3,5mm<br>Implants<br>4,0mm and 5,0mm for 4,0mm<br>Implants<br>5,0mm and 6,0mm for 5,0mm<br>Implants |
| 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 healing<br>abutment are similar as the pridicate<br>device and made for the same<br>indication. | |
| Conclusion: | The PerioType X-Pert Healing abutment is equivalent to the predicate device<br>because they are made from the same material and they have got the same<br>function. 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-Pert<br>Premarket 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.
{16}------------------------------------------------
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
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 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.
