(269 days)
No
The document describes a CAD/CAM fabricated dental abutment designed based on clinician prescription, with no mention of AI or ML in the design or manufacturing process.
No.
The device is an abutment for connecting a prosthetic device to a dental implant, not a therapeutic device designed for treatment or therapy.
No
The device is an abutment for dental implants, intended to support prosthetic devices or function as a substructure for final restorations. Its purpose is mechanical support, not diagnosis.
No
The device description clearly states it is a physical abutment fabricated using CAD/CAM technology, intended to be implanted and support a prosthesis. This is a hardware 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 a device used in vivo (within the body) to support prosthetic devices in the mouth. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implant abutment designed to be placed in a patient's jawbone.
- Anatomical Site: The specified anatomical site is the mandible or maxilla, which are parts of the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
Therefore, the ATLANTIS™ Abutment is a medical device, but it falls under a different regulatory category than In Vitro Diagnostics.
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 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 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.
ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
ATLANTISTM Abutment for NobelActive 3.0 is provided in three designs: ATLANTISTM Abutment for NobelActive, ATLANTIS™ Crown Abutment for NobelActive and ATLANTISTM Conus Abutment for NobelActive. All are patient specific fabricated abutments using CAD/CAM technology. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained. 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 ATLANTISTM Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTISTM Crown Abutment). The implant/abutment interface is compatible with the NobelActive 3.0 implant.
ATLANTISTM Abutment for NobelActive 3.0 has an internal connection and is provided for implant platform diameter O3.0 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
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, 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 NobelActive 3.0 is compatible with the NobelActive 3.0 implant. Mechanical testing results show that the ATLANTISTM Abutment for NobelActive 3.0 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, but instead of snakes, it features three abstract human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
DENTSPLY International, Inc. Ms. Helen Lewis Director of Corporate Regulatory Affairs Susquehanna Commerce Center 221 W. Philadelphia St., Suite 60 York, Pennsylvania 17401
Re: K151039
Trade/Device Name: ATLANTISTM Abutment for NobelActive 3.0 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 10, 2015 Received: December 14, 2015
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 4. INDICATIONS FOR USE STATEMENT
K151039 510(k) Number (if known):
Device Name: ATLANTISTM Abutment for NobelActive 3.0
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 the 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 attachmentretained 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Image /page/3/Picture/1 description: The image shows the word "DENTSPLY" in large, bold, black letters. The letters are closely spaced together, creating a strong visual impact. A thin gray line is positioned above the word, adding a subtle contrast to the overall design.
510(k) SUMMARY for ATLANTISTM Abutment for NobelActive 3.0
-
- Submitter Information:
DENTSPLY International, Inc. Susquehanna Commerce Center 221 West Philadelphia Street, Ste. 60 York, PA 17401
- Submitter Information:
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
Date Prepared: 12 January 2015
-
- Device Name:
- Proprietary Name: .
- Classification Name: .
- CFR Number: .
- Device Class: .
- Product Code: .
ATLANTISTM Abutment for NobelActive 3.0 Endosseous dental implant abutment 21 CFR 872.3630
- Class II NHA
3. Predicate Devices:
The subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
| Table 3.1 | |||
|---|---|---|---|
| Predicate Device Name | 510(k) | Company Name | |
| ATLANTISTM Abutment for Nobel Biocare Active | |||
| Implant (Primary Predicate Device) | K093483 | Astra Tech Inc. * | |
| OsseoSpeed Profile EV (Reference Predicate Device) | K130999 | DENTSPLY Implants | |
| NobelActive 3.0 (Reference Predicate Device) | K102436 | Nobel Biocare AB |
- = Astra Tech Inc. is the original applicant. 510(k) was transferred to DENTSPLY International Inc. after purchase of Astra Tech Inc.
Description of Device: 4.
ATLANTISTM Abutment for NobelActive 3.0 is provided in three designs: ATLANTISTM Abutment for NobelActive, ATLANTIS™ Crown Abutment for NobelActive and ATLANTISTM Conus Abutment for NobelActive. All are patient specific fabricated abutments using CAD/CAM technology. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained. cement-retained or friction fit prosthesis.
Traditional 510(k) ATLANTISTM Abutment for NobelActive 3.0 DENTSPLY International
DENTSPLY International
World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street Suite 60W York, PA 17401 (800) 877-0020 Fax (717) 849-4343 www.dentsply.com
4
The coronal portion of the ATLANTIS™ abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTISTM Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTISTM Crown Abutment). The implant/abutment interface is compatible with the NobelActive 3.0 implant.
ATLANTISTM Abutment for NobelActive 3.0 has an internal connection and is provided for implant platform diameter Ø3.0 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.
Indications for Use: 5.
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 screw is intended to secure the ATLANTISTM 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.
ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.
-
- Substantial Equivalence:
Technological Characteristics.
ATLANTISTM Abutment for NobelActive 3.0 is a patient specific restorative device designed under the control of DENTSPLY and manufactured by DENTSPLY using CAD/CAM technology.
5
Table 6.1 below describes the differences and similarities of the subject and predicate devices.
| Table 6.1 | Table 6.1 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Subject Device | Predicate Devices | Subject Device | Predicate Devices | ||||||
| DENTSPLY | |||||||||
| Implants | |||||||||
| ATLANTISTM | |||||||||
| Abutment for | |||||||||
| NobelActive 3.0 | Astra Tech, Inc. | ||||||||
| ATLANTISTM | |||||||||
| Abutment for | |||||||||
| Nobel Biocare | |||||||||
| Active Implant | |||||||||
| K093483 | DENTSPLY | ||||||||
| Implants | |||||||||
| OsseoSpeed™ | |||||||||
| Profile EV | |||||||||
| K130999 | Nobel Biocare AB | ||||||||
| NobelActive 3.0 | |||||||||
| K102436 | DENTSPLY | ||||||||
| Implants | |||||||||
| ATLANTISTM | |||||||||
| Abutment for | |||||||||
| NobelActive 3.0 | Astra Tech, Inc. | ||||||||
| ATLANTISTM | |||||||||
| Abutment for | |||||||||
| Nobel Biocare | |||||||||
| Active Implant | DENTSPLY | ||||||||
| Implants | |||||||||
| OsseoSpeedTM | |||||||||
| Profile EV | Nobel Biocare AB | ||||||||
| NobelActive 3.0 | |||||||||
| K102436 | |||||||||
| 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 | |||||||||
| 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 | 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 | |||||||||
| cement or screw | |||||||||
| retained to the | |||||||||
| abutment. The | |||||||||
| abutment screw is | |||||||||
| intended to secure | |||||||||
| the abutment to | |||||||||
| the endosseous | |||||||||
| implant. | |||||||||
| This device is | |||||||||
| compatible with | |||||||||
| the following | |||||||||
| manufacturers' | |||||||||
| implant systems: | |||||||||
| The titanitun and | |||||||||
| zirconia | |||||||||
| abutments are | |||||||||
| compatible with | |||||||||
| the Nobel | |||||||||
| Biocare's | |||||||||
| NobelActive | |||||||||
| Implants. | |||||||||
| Please note: This | 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 use | |||||||||
| in soft bone | |||||||||
| applications | |||||||||
| where implants | |||||||||
| with other implant | |||||||||
| surface treatments | |||||||||
| may be less | |||||||||
| effective | |||||||||
| • immediate and | |||||||||
| early loading for | |||||||||
| all indications | |||||||||
| • together with | |||||||||
| immediate | |||||||||
| loading protocol | The NobelActive | ||||||||
| 3.0 mm implant is | |||||||||
| indicated for use. | |||||||||
| In the treatment of | |||||||||
| missing maxillary | |||||||||
| lateral incisors or | |||||||||
| the mandibular | |||||||||
| central and lateral | |||||||||
| incisors to support | |||||||||
| prosthetic devices, | |||||||||
| such as artificial | |||||||||
| teeth, In order to | |||||||||
| restore chewing | |||||||||
| function in | |||||||||
| partially | |||||||||
| edentulous | |||||||||
| patients. The | |||||||||
| NobelActive 3.0 | |||||||||
| implants may be | |||||||||
| put into immediate | |||||||||
| function provided | |||||||||
| that stability | |||||||||
| requirements | |||||||||
| detailed in the | |||||||||
| manual are | |||||||||
| satisfied. | K093483 | K130999 | |||||||
| Table 6.1 | Subject Device | Predicate Devices | Design | ||||||
| DENTSPLY | |||||||||
| Implants | Astra Tech, Inc. | ||||||||
| ATLANTISTM | |||||||||
| Abutment for | |||||||||
| Nobel Biocare | |||||||||
| Active Implant | DENTSPLY | ||||||||
| Implants | |||||||||
| OsseoSpeed™ | |||||||||
| Profile EV | Nobel Biocare AB | ||||||||
| NobelActive 3.0 | Prosthesis | ||||||||
| Attachment | Screw-retained | ||||||||
| Cement-retained | |||||||||
| Friction Fit | Screw-retained | ||||||||
| Cement-retained | Screw-retained | ||||||||
| Cement-retained | |||||||||
| Friction Fit | Screw-retained | ||||||||
| Cement-retained | |||||||||
| ATLANTISTM | |||||||||
| Abutment for | |||||||||
| NobelActive 3.0 | K093483 | K130999 | K102436 | Restoration | Single or Multi- | ||||
| unit | Single or Multi- | ||||||||
| unit | Single or Multi- | ||||||||
| unit | Single or Multi- | ||||||||
| unit | |||||||||
| 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
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 ATLANTISTM
Conus Abutment
to the endosseous
implant.
ATLANTISTM
Abutment for
NobelActive 3.0
is compatible with
the Ø3.0 mm | device may be
used in an early
load situation, but
is dependent on
the specific
implant system
and protocol used
by the dental
professional.
Highly angled
abutments (i.e. 30
degrees) on
implants with
diameters less
than 4 mm are
intended for the
anterior region of
the mouth and are
not intended for
the posterior
region due to
limited strength of
the implant. | 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
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
Diameter | 3.0 | 3.5, 4.3, 5.0 | 3.0, 4.2, 4.8 | 3.0 |
| Subject Device | Predicate Devices | | | Abutment
Angle | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | |
| DENTSPLY
Implants
ATLANTISTM
Abutment for
NobelActive 3.0 | Astra Tech, Inc.
ATLANTISTM
Abutment for
Nobel Biocare
Active Implant | DENTSPLY
Implants
OsseoSpeed™
Profile EV | Nobel Biocare AB
NobelActive 3.0 | Connection | Internal | Internal | Internal | Internal | |
| | K093483 | K130999 | K102436 | Material | | | | | |
| NobelActive
Implant. | | 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
ATLANTISTM
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 | | Implant | NA | NA | Titanium | Titanium | |
| Subject Device | Predicate Devices | | | Abutment | Titanium alloy | Titanium alloy,
Zirconia | Titanium alloy,
Zirconia | Titanium alloy | |
| DENTSPLY
Implants
ATLANTISTM
Abutment for
NobelActive 3.0 | Astra Tech, Inc.
ATLANTISTM
Abutment for
Nobel Biocare
Active Implant
K093483 | DENTSPLY
Implants
OsseoSpeed™
Profile EV
K130999 | Nobel Biocare AB
NobelActive 3.0
K102436 | Screw | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | |
| | | 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 ATLANTISTM
Abutment to the
endosseous
implant.
ATLANTISTM
Abutment,
ATLANTISTM
Crown Abutment
and
ATLANTISTM
Conus Abutment
are compatible
with ASTRA | | | | | | | |
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Biocompatibility
The results of biocompatibility testing conducted for the predicate devices, ATLANTIS™ Abutment for Nobel Biocare Active Implant (K093483) and OsseoSpeed Profile EV (K130999), are valid, therefore, no additional biocompatibility testing has been performed.
Sterility
The results from the previous sterility testing are valid for the proposed device, ATLANTIS™ Abutment for NobelActive 3.0. The sterility testing conducted for the predicate devices, ATLANTIS™ Abutment for Nobel Biocare Active Implant (K093483) and OsseoSpeed Profile EV (K130999), was conducted with the same materials and same sterilization cycle. Therefore, no additional sterility testing was required.
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7. Non-Clinical Performance Data.
Non-clinical testing data, 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 NobelActive 3.0 is compatible with the NobelActive 3.0 implant. Mechanical testing results show that the ATLANTISTM Abutment for NobelActive 3.0 has sufficient strength for its intended use.
Conclusion Regarding Substantial Equivalence
The ATLANTIS™ Abutment for NobelActive 3.0 is an endosseous dental implant abutment which is intended to support a prosthetic device in a partially or completely edentulous patient. The ATLANTISTM Abutment for NobelActive 3.0 has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate devices ATLANTIS™ Abutment for Nobel Biocare Active Implant (K093483), OsseoSpeed Profile EV (K130999) and NobelActive 3.0 (K102436).
The subject device when compared to the predicate devices support substantial equivalence.