(153 days)
K#101004
Not Found
No
The summary describes a physical dental abutment and crown abutment made of zirconia and titanium. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on physical testing (static and fatigue compression).
No.
The device is an abutment for a dental implant, which supports a prosthetic device. It is a structural component for dental restoration rather than directly providing therapy.
No
The device is an implant abutment used to support a prosthetic device, not to diagnose a condition.
No
The device description clearly states that the device is made of physical materials (zirconia and titanium) and is a physical component (abutment) intended for surgical implantation. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Atlantis Abutment and Atlantis™ Crown Abutment are dental devices intended for use with endosseous implants to support prosthetic devices in the mouth. They are physical components placed within the patient's body.
- Lack of Diagnostic Function: The device's purpose is structural support for dental prosthetics, not the analysis of biological samples for diagnostic purposes.
The text describes a medical device used in a surgical/dental procedure, not an in vitro diagnostic test.
N/A
Intended Use / 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, screw retained or friction fit 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 Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
The Atlantis™ Crown Abutment in Zirconia 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 crown abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems: the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
Please note: This 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 on small diameter implants are intended for the anterior region of the mouth only.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Atlantis Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply AnkylosImplant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
Please note: This 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 angulated abutments on small implants are to be used for the anterior region of the mouth only.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are for cemented, screw retained or friction fit restorations. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla (oral cavity)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional, Prescription Use
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)
Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies using Atlantis angled zirconia abutments with the Dentsply Ankylos Implant. Test results demonstrated that the Atlantis Abutments and Atlantis Crown Abutments are compatible with the Dentsply Ankylos Implant and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.
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.
K#101004
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.
Not Found
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
Kl20338
Premarket Notification Section 5: Page - 4
5 2012 JUL
510(k) Summary
Astra Tech Inc. Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant
ADMINISTRATIVE INFORMATION
| 510K Summary preparation date: | July 5, 2012 |
|---|---|
| Manufacturer Name: | Astra Tech Inc. |
| 590 Lincoln Street | |
| Waltham, Massachusetts 02541 | |
| Telephone: 781-810-6462 | |
| Fax: 781-810-6719 | |
| Official Contact: | Frank Uyleman |
| Representative/Consultant: | Betsy A. Brown |
| B.A. Brown and Associates Inc. | |
| Telephone: 847-560-4406 | |
| Fax: 847-677-0177 |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | AtlantisTM Abutment and AtlantisTM Crown Abutment in
Zirconia for Dentsply Ankylos Implant |
|-------------------------|-----------------------------------------------------------------------------------------------|
| Common Name: | Endosseous dental implant abutment
21 CFR 872.3630 |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
INTENDED 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, screw retained or friction fit 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:
1
The Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
The Atlantis™ Crown Abutment in Zirconia 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 crown abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems: the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
Please note: This 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 on small diameter implants are intended for the anterior region of the mouth only.
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, screw retained or friction fit to the abutment screw is intended to secure the abutment to the endosseous implant.
2
Premarket Notification Section 5: Page - 5
DEVICE DESCRIPTION AND CLINICAL USE
The Atlantis Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply AnkylosImplant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
Please note: This 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 angulated abutments on small implants are to be used for the anterior region of the mouth only.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are for cemented, screw retained or friction fit restorations. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
EQUIVALENCE TO MARKETED DEVICE
Astra Tech Inc. demonstrated that, for purposes of the FDA's regulations of medical devices, the Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant is substantially equivalent in indication and design principles to the AtlantisTM Abutment for Dentsply Ankylos Implant cleared under K#101004 which has been determined by FDA to be substantially equivalent to preamendment devices.
3
Premarket Notification Section 5: Page – 6
| Technological
Characteristics | Atlantis™ Abutment and
Atlantis™ Crown
Abutment in Zirconia for
Dentsply Ankylos Implant | Atlantis™ Abutment for
Dentsply Ankylos Implant
K#101004 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material
Composition | -Biocompatible ceramic
material (abutment)
- comparable compatible
titanium grade Ti-6A-4V ELI
material (screw assembly) | -comparable compatible titanium
grade Ti-6A-4V ELI material |
| Performance
characteristics | Allows the prosthesis to be
cemented or screw retained
to abutment. While the
abutment screw is intended
to secure the abutment to the
endosseous implant. | Allows the prosthesis to be
cemented or screw retained to
abutment. While the abutment
screw is intended to secure the
abutment to the endosseous
implant. |
| Intended 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, screw retained
or friction fit 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 Atlantis Abutment in
Zirconia for Dentsply
Ankylos Implant is
compatible with the Dentsply
Ankylos 3.5mm, 4.5mm, | 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, 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
in Zirconia 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. |
| Intended Use
(continued) | 5.5mm and 7.0mm Implants.
The Atlantis™ Crown
Abutment in Zirconia 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 crown abutment to the
endosseous implant.
This device is compatible
with the following
manufacturers' implant
systems:
the Dentsply Ankylos
3.5mm, 4.5mm, 5.5mm and
7.0mm Implants.
Please note: This 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 on
small diameter implants are
intended for the anterior
region of the mouth only. | The abutment screw is intended
to secure the crown abutment to
the endosseous implant. |
| Device Description and
Clinical Use | The Atlantis Abutment and
Atlantis™ Crown Abutment
in Zirconia for Dentsply
Ankylos | The Atlantis Abutment and
Atlantis™ Crown Abutment in
Zirconia for Dentsply Ankylos
Implant is compatible with the |
| Implant is compatible with
the Dentsply Ankylos
3.5mm, 4.5mm, 5.5mm and
7.0mm Implants.
Please note: This 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 angulated abutments
on small implants are to be
used for the anterior region
of the mouth only. The
devices covered in this
submission are abutments
which are placed into the
dental implant to provide
support for a prosthetic
restoration. The subject
abutments are for cemented,
screw retained or friction fit
restorations. | Dentsply Ankylos 3.5mm,
4.5mm, 5.5mm and 7.0mm
Implants.
Please note: This 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 angulated abutments on
small implants are to be used for
the anterior region of the mouth
only.
The devices covered in this
submission are abutments which
are placed into the dental implant
to provide support for a prosthetic
restoration. The subject
abutments are for cemented,
screw retained or friction fit
restorations. | |
| Dimensions and
Angulation | Abutment sizes: 3.5mm,
4.5mm, 5.5mm and 7.0mm
Atlantis Abutments design
only allows for geometry
within the following limits:
-Angles up to 30 degrees
from the implant axis
-Widths up to 6.5 mm from
the implant axis
-Heights (length) up to 15
mm from the implant
interface | Implant sizes: 3.5mm, 4.5mm,
5.5mm and 7.0mm
Atlantis Abutments design only
allows for geometry within the
following limits:
-Angles up to 30 degrees from the
implant axis
-Widths up to 6.5 mm from the
implant axis
-Heights (length) up to 15 mm
from the implant interface |
Table 1: Substantial Equivalence Summary
،
.
4
.
·
·
5
:
:
.
6
Summary of Non-clinical Testing
Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies using Atlantis angled zirconia abutments with the Dentsply Ankylos Implant. Test results demonstrated that the Atlantis Abutments and Atlantis Crown Abutments are compatible with the Dentsply Ankylos Implant and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.
Conclusion for Substantial Equivalence:
The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant is substantially equivalent to the Atlantis™ Abutment for Dentsply Ankylos Implant K#101004 predicate device based on noted similarities in indication, manufacturing material, generated design principle and performance characteristics data.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/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 an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Astra Tech, Incorporated C/O Ms. Betsy Brown Regulatory Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
5 2012 JUL
Re: K120338
Trade/Device Name: Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 9, 2012 Received: June 12, 2012
Dear Ms. Brown:
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.
8
Page 2 - Ms. Brown
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Anthony D. Awater
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Premarket Notification
Section 4: Page - 3
| 510(k) Number (if known) | K120338 |
|---|---|
| -------------------------- | --------- |
Indications for Use
| Device Name: | Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant |
|---|---|
| -------------- | ------------------------------------------------------------------------------------------ |
Indication 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, screw retained or friction fit 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 Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
The Atlantis™ Crown Abutment in Zirconia 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 crown abutment to the endosseous
implant.
This device is compatible with the following manufacturers' implant systems:
the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
Please note: This 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 on small diameter implants are intended for the anterior region of the mouth only.
| Prescription Use | X |
|---|---|
| (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
i, Dol Infection
K 120 338 510(k) Number: __
510K Number: