(175 days)
HIOSSEN Implant System (K140934)
No
The device description focuses on CAD/CAM fabrication of patient-specific abutments based on clinician prescriptions, with no mention of AI or ML for design or analysis.
No.
The device is a dental implant abutment designed to support a prosthetic device, not provide therapy.
No
The device description and intended use clearly state that the ATLANTIS™ Abutment is a prosthetic device (an endosseous dental implant abutment) intended to support a prosthetic device or act as a final restoration. It does not perform any diagnostic function.
No
The device description clearly states that the ATLANTIS™ Abutment is a physical endosseous dental implant abutment fabricated using CAD/CAM technology. It is a hardware component intended for physical implantation and support of a prosthesis.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental implant abutment used to support prosthetic devices in patients. This is a surgical/restorative device, not a diagnostic one.
- Device Description: The description details the physical characteristics and function of the abutment as a component of a dental implant system.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on mechanical testing and compatibility, which are relevant for a medical device but not for an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The ATLANTISTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant.
The ATLANTISTM Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS Crown Abutment to the endosseous implant.
The ATLANTISTM Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant.
ATLANTISTM products are compatible with the implants shown in the table below.
Implant Manufacturer - HIOSSEN INC
Trade Name Abutment Platform Diameter HIOSSEN ET III SA Fixture Mini 03.5mm HIOSSEN ET III SA Fixture Regular 04.0, 4.5, 5.0, 6.0, 7.0 mm
Implant Diameter 03,5mm Ø4.0. 4.5. 5.0. 6.0. 7.0 mm
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The proposed ATLANTIS™ Abutment for HIOSSEN ET implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (03.5, 4.0, 4.5, 5.0. 6.0 and 7.0 mm) and three designs: ATLANTIS™ Abutment for HIOSSEN ET implant, ATLANTIS™ Crown Abutment for HIOSSEN ET implant and ATLANTIS™ Conus Abutment for HIOSSEN ET implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at DENTSPLY Implant sites. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained, cement-retained or friction fit prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes mechanical design analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants.
Compatibility analysis shows that the ATLANTIS™ Abutment for HIOSSEN ET implant is compatible with the Mini (3.5 mm) and Regular (4.0, 4.5, 5.0, 6.0 and 7.0 mm) HIOSSEN ET implants. Mechanical testing results show that the ATLANTIS™ Abutment for HIOSSEN ET implant has sufficient strength for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
HIOSSEN Implant System (K140934)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2016
Dentsply Sirona Ms. Helen Lewis Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
Re: K160626
Trade/Device Name: ATLANTISTM Abutment for HIOSSEN ET implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: July 21, 2016 Received: July 22, 2016
Dear Ms. Lewis:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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/Resourcesfor You/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 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,
Image /page/1/Picture/8 description: The image shows a signature and the name "Tina Kiang" written in black ink. The signature is illegible and consists of a series of loops and lines. The text "Tina Kiang" is written in a simple, sans-serif font and is positioned to the right of the signature. There is a faint FDA logo in the background.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160626
Device Name
ATLANTISTM Abutment for HIOSSEN ET implant
Indications for Use (Describe)
The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant.
The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS Crown Abutment to the endosseous implant.
The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant.
ATLANTISTM products are compatible with the implants shown in the table below.
Implant Manufacturer - HIOSSEN INC
Trade Name Abutment Platform Diameter HIOSSEN ET III SA Fixture Mini 03.5mm HIOSSEN ET III SA Fixture Regular 04.0, 4.5, 5.0, 6.0, 7.0 mm
Implant Diameter 03,5mm Ø4.0. 4.5. 5.0. 6.0. 7.0 mm
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
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SECTION 5. 510(k) SUMMARY for
ATLANTISTM Abutment for HIOSSEN ET implant
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17401
- Submitter Information:
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
August 17, 2016 Date Prepared:
-
- Device Name:
- Proprietary Name: .
ATLANTISTM Abutments for HIOSSEN ET implant
- Classification Name: Endosseous dental implant abutment
- . . CFR Number:
- 21 CFR 872.3630 Device Class: II
- NHA Product Code: .
3. Predicate Device:
.
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Osseospeed™ Profile EV | ||
| (Primary Predicate Device) | K130999 | DENTSPLY IMPLANTS |
| MANUFACTURING GMBH | ||
| HIOSSEN Implant System | ||
| (Reference Predicate Device) | K140934 | HIOSSEN INC |
4. Description of Device:
The proposed ATLANTIS™ Abutment for HIOSSEN ET implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (03.5, 4.0, 4.5, 5.0. 6.0 and 7.0 mm) and three designs: ATLANTIS™ Abutment for HIOSSEN ET implant, ATLANTIS™ Crown Abutment for HIOSSEN ET implant and ATLANTIS™ Conus Abutment for HIOSSEN ET implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at DENTSPLY Implant sites. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained, cement-retained or friction fit prosthesis.
4
SECTION 5. 510(k) SUMMARY (continued)
Table 5-1: Compatibility table (The ATLANTIS Abutment Titanium, Zirconia and Goldshaded are compatible with HIOSSEN ET implant interface (Ø3.5, 4.0, 4.5, 5.0, 6.0, 7.0 mm)
| Implant
Manufacturer | Interface | ATLANTISTM
Abutment for
HIOSSEN ET
implant | ATLANTISTM
Crown
Abutment for
HIOSSEN ET
implant | ATLANTISTM Conus
Abutment
for
HIOSSEN
ET implant
(Custom) | ATLANTISTM
Conus
Abutment
HIOSSEN ET
implant
(Overdenture) |
|-------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------|
| HIOSSEN INC | HIOSSEN
Implant
System
(HIOSSEN
ET implant)
(Ø3.5, 4.0,
4.5, 5.0, 6.0,
7.0 mm) | Titanium,
Zirconia, Gold-
shaded titanium
(Gold-Hue) | Titanium,
Zirconia | Titanium,
Gold-shaded
titanium
(Gold-Hue) | Titanium |
The coronal portion of the ATLANTIS™ Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTIS™ Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS™ Crown Abutment). The ATLANTIS™ abutment interface is compatible with the HIOSSEN ET implants from the HIOSSEN Implant System (K140934).
The HIOSSEN ET implant interface is a slight conical (11°) internal hex connection and provided for implant platform diameter Mini (3.5 mm), and Regular (4.0, 4.5, 5.0, 6.0 and 7.0 mm). The abutment diameter ranges from 3.3 to 13 mm. the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation.
న. Indications for Use:
The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant.
The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS Crown Abutment to the endosseous implant.
5
SECTION 5. 510(k) SUMMARY (continued)
The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant.
ATLANTIS™ products are compatible with the implants shown in the table below.
| Implant
Manufacturer | Trade Name | Abutment
Platform Diameter | Implant Diameter | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| HIOSSEN INC | HIOSSEN ET III SA Fixture Mini | Ø3,5mm | Ø3,5mm | |
| HIOSSEN INC | HIOSSEN ET III SA Fixture Regular | Ø4.0, 4.5, 5.0, 6.0,
7.0 mm | Ø4.0, 4.5, 5.0, 6.0,
7.0 mm | |
| Table 5-2: Indications for use for the proposed and the predicate devices
ATLANTIST™ Abutment for HIOSSEN ET
implant (Proposed Device) | OsseoSpeed Profile EV (K130999)
(Primary Predicate) | HIOSSEN Implant System (K140934)
(Reference Predicate) | Summary of differences in
the indications for use | |
| The ATLANTIST™ Abutment is intended for use
with an endosseous implant to support a prosthetic
device in a partially or completely edentulous
patient. It is intended for use to support single and
multiple tooth prosthesis, in mandible or maxilla.
The prosthesis can be cemented or screw retained to
the abutment. The abutment screw is intended to
secure the ATLANTIS Abutment to the endosseous
implant. | Implants:
The ASTRA TECH Implant System –
OsseoSpeed Profile EV implants are
intended for both one- and two-stage
surgical procedures in the following
situations and with the following clinical
protocols:
Replacing missing teeth in single or
multiple unit applications in the
mandible or maxilla. Immediate placement in extraction
sites and in situations with a
partially or completely healed
alveolar ridge Especially indicated for us in soft
bone applications where implants
with other implant surface treatment
may be less effective Immediate and early loading for all
indications Together with immediate loading
protocol in all indications, except in
single tooth situations in soft bone
(type IV) where implant stability
may be difficult to obtain and
immediate loading may not be
appropriate Only together with Profile EV
components, Implant Driver Profile
EV, Radiographic Implant Guides
Profile EV and non-Indexed
prosthetic components | The HIOSSEN Implant System is indicated
for use in partially or fully edentulous
mandibles and maxillae, in support of single
or multiple-unit restorations including;
cemented retained, screw retained, or
overdenture restorations, and final or
temporary abutment support for fixed
bridgework. It is intended for delayed
loading. ETIII SA Ultra-Wide Fixture is
intended to be used in the molar region. | The indications for use of the
proposed device are similar to the
indications for use of the primary
predicate device. The difference is
that the primary predicate device also
includes the indications for use of the
implants, which is not the subject of
this submission. | |
| The ATLANTIST™ Crown Abutment is intended
for use with an endosseous implant to function as a
substructure that also serves as the final restoration,
in a partially or completely edentulous patient. The
abutment screw is intended to secure the ATLANTIS
Crown Abutment to the endosseous implant. | Abutments:
ASTRA TECH Implant System™-
OsseoSpeed EV abutments are intended
to be used in conjunction with ASTRA
TECH Implant System™-OsseoSpeed
EV in fully edentulous or partially
edentulous maxillary and/or mandibular
arches. | | The indications for use of the
reference predicate device cover the
entire dental system. | |
| The ATLANTIST™ Conus Abutment is intended
for use with an endosseous implant to support a
prosthetic device in partially or completely
edentulous patients. It is intended for use to support a
removable multiple tooth prosthesis, in the mandible
or maxilla. The prosthesis is attachment-retained by
friction fit to the abutment. The abutment screw is
intended to secure the ATLANTIS Conus Abutment
to the endosseous implant. | | | The indications for use are similar.
The difference between the proposed
device and the reference predicate
device is that the prosthesis, in
addition to screw-retained restoration
or cement retained restoration, can be
attachment-retained (by friction fit)
to the proposed device. | |
| ATLANTIST™ products are compatible with the
implants shown in the table below. | | | | |
| Implant
Manufacturer | Trade Name | Abutment
Platform
Diameter | Implant
Diameter | |
| HIOSSEN INC | HIOSSEN ET III SA
Fixture Mini | Ø3,5mm | Ø3,5mm | |
| | HIOSSEN ET III SA
Fixture Regular | Ø4.0, 4.5,
5.0, 6.0, 7.0
mm | Ø4.0, 4.5,
5.0, 6.0, 7.0
mm | |
| ATLANTISTM Abutment for HIOSSEN ET
implant (Proposed Device) | OsseoSpeed Profile EV (K130999)
(Primary Predicate) | HIOSSEN Implant System (K140934)
(Reference Predicate) | Summary of differences in
the indications for use | |
| | The ATLANTIST™ Abutment is
intended for use with an endosseous
implant to support a prosthetic device in
a partially or completely edentulous
patient. It is intended for use to support
single and multiple tooth prostheses, in
the mandible or maxilla. The prosthesis
can be cemented, screw retained or
friction fit to the abutment. The
abutment screw is intended to secure the
abutment to the endosseous implant. | | | |
| | The ATLANTIST™ Crown Abutment
is intended for use with an endosseous
implant to function as a substructure that
also serves as the final restoration, in
partially or completely edentulous
patients. The prosthesis is screw
retained. The abutment screw is intended
to secure the ATLANTIST™ Abutment to
the endosseous implant. | | | |
| | The ATLANTIS Conus Abutment is
intended for use with an endosseous
implant to support a prosthetic device in
partially or completely edentulous
patients. It is intended for use to support
a removable multiple tooth prosthesis, in
the mandible or maxilla. The prosthesis
is attachment-retained by friction fit to
the abutment. The abutment screw is
intended to secure the ATLANTIS
Abutment to the endosseous implant. | | | |
| | ATLANTISTM Abutment,
ATLANTISTM Crown Abutment and
ATLANTISTM Conus Abutment are
compatible with ASTRA TECH Implant
System Profile EV | | | |
6. Substantial Equivalence:
Technological Characteristics:
ATLANTIS™ Abutment for HIOSSEN ET implant is a patient specific restorative device designed under the control of DENTSPLY Implants and manufactured by DENTSPLY Implants using CAD/CAM technology.
Table 5-2 and 5-3 below summarizes the differences and similarities of the subject and predicate devices.
6
7
:
8
Table 5-3: Similarities and differences between the proposed and the predicate devices
| Element | 510(k) | Prosthesis Attachment | Restoration | Abutment Platform Diameter | Abutment angle | Connection | Material Implant | Material: Abutment | Material: Screw | Proposed Device
ATLANTISTM Abutment for HIOSSEN ET
implants | Primary Predicate
Device
OsseoSpeed Profile
EV
K130999 | Reference
Predicate Device
HIOSSEN
Implant System
K140934 | Summary of differences |
|---------|--------|-----------------------|-------------|----------------------------|----------------|------------|------------------|--------------------|------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | | | | | | | | | | To be assigned | | | |
| | | | | | | | | | | Screw-retained
Cement-retained
Friction Fit | Screw-retained
Cement-retained | No difference between the
proposed and the primary
predicate device. The reference
device does not indicate friction
fit. | |
| | | | | | | | | | | Single or Multi-unit | Single or Multi-unit | No difference. | |
| | | | | | | | | | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.0, 4.2, 4.8 | 3.5, 4.0, 4.5, 5.0, 6.0,
7.0 | The proposed device is designed
to fit the HIOSSEN ET
interface. Therefore, no
difference between the proposed
device and the reference
predicate device. | |
| | | | | | | | | | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | No difference. | |
| | | | | | | | | | Internal hex connection | Internal conical
connection | Internal hex
connection | There is no difference between
the proposed device and the
reference predicate device. | |
| | | | | | | | | | NA | Titanium | Titanium | The proposed device is an
abutment. | |
| | | | | | | | | | Titanium alloy, Zirconia | Titanium alloy, Zirconia | Titanium alloy,
Zirconia | No difference. | |
| | | | | | | | | | Titanium alloy | Titanium alloy | Titanium alloy | No difference. | |
9
Biocompatibility
The results of biocompatibility testing conducted for the predicate device, OsseoSpeed Profile EV (K130999), are valid because the material composition of the proposed device is similar to the ATLANTIS™ Abutments covered by the predicate device, OsseoSpeed Profile EV (K130999). Therefore, no additional biocompatibility testing has been conducted.
Sterility
The sterility testing conducted for the predicate device, OsseoSpeed Profile EV (K130999), was conducted with the same materials and same sterilization cycle. Therefore, no additional sterility testing was required for the proposed device, ATLANTIS™ Abutment for HIOSSEN ET implant.
7. Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes mechanical design analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants.
Compatibility analysis shows that the ATLANTIS™ Abutment for HIOSSEN ET implant is compatible with the Mini (3.5 mm) and Regular (4.0, 4.5, 5.0, 6.0 and 7.0 mm) HIOSSEN ET implants. Mechanical testing results show that the ATLANTIS™ Abutment for HIOSSEN ET implant has sufficient strength for its intended use.
Conclusion Regarding Substantial Equivalence 8.
The ATLANTIS™ Abutment for HIOSSEN ET implant is an endosseous dental implant abutment which is intended to support a prosthetic device in a partially or completely edentulous patient. The ATLANTIS™ Abutment for HIOSSEN ET implant has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicates. Osseospeed™ Profile EV (K130999) and HIOSSEN Implant System (K140934). Test data to verify the performance of the ATLANTISTM Abutment for HIOSSEN ET implant has been provided including: mechanical testing and compatibility analysis. The results of this testing, combined with the design, and intended use comparison with the predicate devices, support substantial equivalence.