(135 days)
No
The document describes a dental implant abutment fabricated using CAD/CAM technology based on clinician prescriptions. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device acts as a substructure to support prosthetic devices after an endosseous implant, it does not directly diagnose, treat, or prevent disease.
No
The device description indicates that the ATLANTIS™ Abutment is an endosseous dental implant abutment designed to support a prosthetic device. Its function is to interface between an implant and a dental prosthesis, not to diagnose a condition.
No
The device description clearly states it is a physical dental implant abutment fabricated using CAD/CAM technology, not a software-only device.
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 from the human body (blood, tissue, etc.) to provide diagnostic information.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a physical component used in a dental restoration procedure.
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 | Trade Name | Implant Diameter | Abutment Platform Diameter |
|---|---|---|---|
| Altatec GmbH | CONELOG SCREW-LINE Implant | Ø3.3, 3.8, 4.3, 5.0 mm | Ø3.3, 3.8, 4.3, 5.0 mm |
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The proposed ATLANTIS™ Abutment for CONELOG implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.8, 4.3 and 5.0 mm) and three designs: ATLANTIS™ Abutment for CONELOG implant, ATLANTIS™ Crown Abutment for CONELOG implant and ATLANTIS™ Conus Abutment for CONELOG 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 screwretained, cement-retained or friction fit prosthesis.
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 CONELOG implants from the CONELOG Implant System (K113779).
The CONELOG implant interface is an internal connection with indexing feature (three grooves) and provided for implant platform diameter (3.3, 3.8, 4.3 and 5.0 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.
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
partially or completely edentulous patient
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 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 CONELOG implant is compatible with the (3.3, 3.8, 4.3 and 5.0 mm) CONELOG implants. Mechanical testing results show that the ATLANTIS™ Abutment for CONELOG 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.
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 26, 2016
Dentsply Sirona Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
Re: K161030
Trade/Device Name: ATLANTISTM Abutment for CONELOG Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 27, 2016 Received: July 29, 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -
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) K161030
Device Name
ATLANTISTM Abutment for CONELOG 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 | Trade Name | Implant Diameter | Abutment Platform Diameter |
|---|---|---|---|
| Altatec GmbH | CONELOG SCREW- | ||
| LINE Implant | Ø3.3, 3.8, 4.3, 5.0 mm | Ø3.3, 3.8, 4.3, 5.0 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
Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape in gray on the left, with a white stripe running through it. To the right of the leaf shape are the words "Dentsply" and "Sirona" stacked vertically, also in gray. The font is sans-serif and modern.
SECTION 5. 510(k) SUMMARY
for
ATLANTISTM Abutment for CONELOG implant
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
- Submitter Information:
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
August 18, 2016 Date Prepared:
-
- Device Name:
- Proprietary Name:
- Classification Name: ●
- CFR Number: ●
- Device Class: .
- Product Code: NHA .
-
- Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| ATLANTIS™ Abutment for | ||
| NobelActive 3.0 (Primary | ||
| Predicate Device) | K151039 | DENTSPLY IMPLANTS |
| MANUFACTURING GMBH | ||
| Osseospeed™ Profile EV | ||
| (Reference Predicate Device) | K130999 | DENTSPLY IMPLANTS |
| MANUFACTURING GMBH | ||
| CONELOG Implant System | ||
| (Reference Predicate Device) | K113779 | Altatec GmbH |
21 CFR 872.3630
II
ATLANTISTM Abutment for CONELOG implant
Endosseous dental implant abutment
-
- Description of Device:
The proposed ATLANTIS™ Abutment for CONELOG implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.8, 4.3 and 5.0 mm) and three designs: ATLANTIS™ Abutment for CONELOG implant, ATLANTIS™ Crown Abutment for CONELOG implant and ATLANTIS™ Conus Abutment for CONELOG 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 screwretained, cement-retained or friction fit prosthesis.
- Description of Device:
4
Table 5-1: Compatibility table (The ATLANTIS Abutment Titanium and Gold-shaded are compatible with CONELOG implant interface (Ø3.3, 3.8, 4.3 and 5.0 mm)
| Implant
Manufacturer | Interface | ATLANTIS
TM
Abutment for
CONELOG
implant | ATLANTISTM
Crown
Abutment
for CONELOG
implant | ATLANTISTM
Conus
Abutment for
CONELOG
implant
(Custom) | ATLANTISTM
Conus Abutment
for CONELOG
implant
(Overdenture) |
|-------------------------|------------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------|
| Altatec GmbH | CONELOG
Implant
System
(SCREW-
LINE) (Ø3.3,
3.8, 4.3 and
5.0 mm) | Titanium,
Gold-shaded
titanium
(Gold-Hue) | Titanium | Titanium | 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 CONELOG implants from the CONELOG Implant System (K113779).
The CONELOG implant interface is an internal connection with indexing feature (three grooves) and provided for implant platform diameter (3.3, 3.8, 4.3 and 5.0 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.
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.
5
ATLANTIS™ products are compatible with the implants shown in the table below.
| Implant
| Manufacturer | Trade Name | Implant Diameter | Abutment Platform Diameter |
|---|---|---|---|
| Altatec GmbH | CONELOG SCREW- | ||
| LINE Implant | Ø3.3, 3.8, 4.3, 5.0 mm | Ø3.3, 3.8, 4.3, 5.0 mm |
-
- Substantial Equivalence:
Technological Characteristics
- Substantial Equivalence:
ATLANTIS™ Abutment for CONELOG implant is a patient specific restorative device designed under the control of DENTSPLY and manufactured by DENTSPLY using CAD/CAM technology.
Table 5-2 and 5-3 below summarizes the differences and similarities of the subject and predicate devices.
6
Table 5-2: Indications for use for the proposed and the predicate devices
| ATLANTISTM Abutment for
CONELOG implant (Proposed | ATLANTISTM Abutment
for NobelActive 3.0 | OsseoSpeed Profile EV
(K130999) | CONELOG Implant System
(K113779) | Summary of differences in
the indications for use |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device) | (K151039)
(Primary Predicate) | (Reference Predicate) | (Reference Predicate) | |
| 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 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 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. The
abutment screw is intended to secure
the ATLANTIS Conus Abutment to
the endosseous implant. | 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 and multiple tooth
prosthesis, in the mandible
or maxilla. The prosthesis
can be cemented or screw
retained to the abutment.
The abutment screw is
intended to secure the
ATLANTISTM
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 ATLANTISTM
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 | 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 | CONELOG® Implant System
Implants are intended for immediate
or delayed placement in the bone of
the maxillary or mandibular arch.
CONELOG® Implant System
Abutments are intended for use as
support for crowns, bridges or
overdentures. When a one-stage
surgical approach is applied, the
implant may be immediately loaded
when good primary stability is
achieved and the functional load is
appropriate.
CONELOG® Implants with Ø3.3
mm diameter have the following
additional specific indications:
These are an alternative in cases
where the alveolar ridge width is
only 5 - 6 mm. Because of their
lower mechanical strength
compared with larger diameter
implants, they should only be used
under the following conditions:
As single implants, they
should be used only to replace
mandibular incisors and/or
maxillary lateral incisors. An edentulous arch can only
be restored with a bar retained
superstructure with at least
four implants of Ø3.3 mm
diameter without distal
extensions. Implants of Ø3.3 mm are
suitable for a partially
edentulous arch when | The indications for use of the
proposed device are identical
to the indications for use of
the primary predicate device.
The indications for use of the
proposed device are similar to
the indications for use of the
reference predicate device
(K130999). The difference is
that the reference predicate
device (K130999) also
includes the indications for
use of the implants, which is
not the subject of this
submission.
The indications for use of the
second reference predicate
device cover the CONELOG
implant system (K113779).
The indications for use are
similar. The difference
between the proposed device
and the reference predicate
device (K113779) 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. |
7
ATLANTIS™ products are compatible with the implants shown in the table below.
| Implant
Manufacturer | Trade
Name | Implant
Diameter | Abutment
Platform
Diameter |
|-------------------------|--------------------------------------|------------------------------|----------------------------------|
| Altatec GmbH | CONELOG
SCREW-
LINE
Implant | Ø3.3, 3.8,
4.3, 5.0
mm | Ø3.3, 3.8,
4.3, 5.0
mm |
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™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.
appropriate
●
- Only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components
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 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 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 ATLANTIS™ 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
combined with implants of larger diameter for splinted superstructures. However, the limited strength of the implants with Ø3.3 mm must be taken into account.
- . Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø3.3 mm implants.
- . The healing time for Ø3.3 mm implants is at least 12 weeks.
CONELOG® Implants with 7 mm length have the following additional specific indications:
CONELOG® SCREW-LINE
Implants should only be used when there is not enough space for a longer implant. Delayed loading in single tooth replacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.
8
| | screw retained. The abutment
screw is intended to secure the
ATLANTIS™ 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,
ATLANTIS™ Crown
Abutment and ATLANTISTM
Conus Abutment are
compatible with ASTRA
TECH Implant System Profile
EV | |
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
|---|
9
Table 5-3: Similarities and differences between the proposed and the predicate devices
| Element | Proposed Device
ATLANTISTM
Abutment for
CONELOG implant | Primary Predicate
Device
ATLANTISTM
Abutment for
NobelActive 3.0 | Reference Predicate
Device
OsseoSpeed Profile
EV | Reference Predicate
Device
CONELOG Implant
System | Summary of differences |
|-------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | To be assigned | K151039 | K130999 | K113779 | - |
| Prosthesis
Attachment | Screw-retained
Cement-retained
Friction Fit | Screw-retained
Cement-retained
Friction Fit | Screw-retained
Cement-retained
Friction Fit | Screw-retained
Cement-retained | No difference between the
proposed device and the primary
predicate and the reference device
(K130999). |
| Restoration | Single or
Multi-unit | Single or
Multi-unit | Single or | Single or
Multi-unit | No difference. |
| Abutment Platform
Diameter | 3.3, 3.8, 4.3, 5.0 | 3.0 | 3.0, 4.2, 4,8 | 3.3, 3.8, 4.3, 5.0 | The proposed abutment platform
is designed to fit the reference
predicate device (K113779).
The proposed device
encompasses the same range of
physical dimensions; diameter,
height and angle of abutments for
the primary predicate as for the
reference predicate (K113779).
The subject abutment platform is
not designed to fit the primary
predicate device (K151039) or the
reference predicate device
(K130999). |
| Abutment angle | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | No difference. |
| Element | Proposed Device
ATLANTISTM
Abutment for
CONELOG implant | Primary Predicate
Device
ATLANTISTM
Abutment for
NobelActive 3.0 | Reference Predicate
Device
OsseoSpeed Profile
EV | Reference Predicate
Device
CONELOG Implant
System | Summary of differences |
| Connection | Internal conical
connection | Internal conical connection | Internal conical
connection | Internal conical
connection | The internal conical connection is
similar for the proposed device
when compared to the primary
predicate device (K151037) or the
reference predicate device
(K130999).
The connection of the proposed
device is designed to fit the
reference predicate (K113779). |
| Material Implant | NA | NA | Titanium | Titanium | The proposed device and primary
predicate is an abutment. |
| Material: Abutment | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | No difference. |
| Material: Screw | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | No difference. |
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7. Biocompatibility
The results of biocompatibility testing conducted for the primary predicate device, ATLANTIS™ Abutment for NobelActive 3.0 (K151039), are valid because the material composition of the proposed device is the same when compared to the primary predicate device, ATLANTISTM Abutment for NobelActive 3.0 (K151039). Atlantis abutments are made of titanium allov conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4Vandadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). As per our biological evaluations on the titanium materials used for the ATLANTIS Abutment (RP-00054490), the following tests were performed: Cytotoxicity, Sensitization, Irritation of Intracutaneous reactivity, Acute systemic toxicity, Subchronic toxicity, Genotoxicity - AMES, and Hemolysis. Since the material composition of the proposed devices is identical to the predicate devices, the result of referenced biocompatibility testing is still valid. Therefore, no additional biocompatibility testing has been performed.
Sterility 8.
The sterility testing conducted for the primary predicate device, ATLANTIS™ Abutment for NobelActive 3.0 (K151039), was conducted with the same materials and same sterilization cycle. Therefore, no additional sterility testing was required for the proposed device, ATLANTIS™ Abutment for CONELOG implant.
9. 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 CONELOG implant is compatible with the (3.3, 3.8, 4.3 and 5.0 mm) CONELOG implants. Mechanical testing results show that the ATLANTIS™ Abutment for CONELOG implant has sufficient strength for its intended use.
9. Conclusion Regarding Substantial Equivalence
The ATLANTIS™ Abutment for CONELOG 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 CONELOG implant has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicates ATLANTIS™ Abutment for NobelActive 3.0 (K151039), Osseospeed Profile EV (K130999) and CONELOG Implant System (K113779).
Test data to verify the performance of the ATLANTIS™ Abutment for CONELOG 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.