(231 days)
Not Found
No
The device description and performance studies focus on mechanical properties and design, with no mention of AI or ML.
No.
The device is described as an endosseous dental implant abutment used for anchorage of dentures, which is a restoration component, not a therapeutic device.
No
Explanation: The device description clearly states it is an "endosseous dental implant abutment" intended for "anchorage of dentures" and "prosthetic restoration." It is a component used in the physical restoration of teeth, not for diagnosing conditions or diseases.
No
The device description explicitly details physical components made of Titanium Alloy and Gold Alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical anchorage of dentures and support of prostheses in the mouth. This is a structural and mechanical function within the body.
- Device Description: The device is a dental implant abutment made of titanium alloy and gold alloy. It is designed to be surgically implanted and provide a connection point for a dental prosthesis.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
- Performance Studies: The performance studies described are fatigue testing and pull force testing, which evaluate the mechanical properties and structural integrity of the device, not its ability to perform a diagnostic test.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic information. This device is a medical device used for structural support within the body.
N/A
Intended Use / Indications for Use
Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants.
Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The ANK YLOS® SynCone Abutiment 5° is an endosseous dental implant abutment which provides a platform for prosthetic restoration in conjunction with ANKYLOS™ implants. The subject device incorporates an abutment head with a 5° conical taper and is provided in angulations of 0° 7.5° 15° 22.5° and 30° and with gingival heights ranging from J.5mm . 4.5mm. The abutment is connected to the corresponding iniblant. by a central screw which mates with the internal thread of the implant. The abuiment and the abutment screw are machined from Titanium Alloy (Ti6AL4V ELI) conforming 10 ASTM F136 (Standard Specification for Wrought Titannum-6 Aluminim-4 Vanadium ELI (Extra Low Interstitial' Alloy for Surgical Implant Applications). The tapered SynCone® 5° caps which anchor the SynCone® abutment on the fixed denture are made of Gold Alloy of Titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The SynCone® abutments feature a reatining screw design which allows for the rotation of the abutment head after attachment to the implant in order to achieve rotational alignment for all of the abutments used in the prosthetic restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Representative fatigue testing was conducted on the subject ANKYLOS® SynCone® Abutments 5° in comparison to the predicate device. The testing was conducted according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous detnal implants) and the results support substantial equivalence.
Pull force testing was conducted to verify the equivalence of the taper friction retention properties of the SynCone® Abutment 5° in comparison with those of the predicate abutments. The results confirmed the equivalence of the performance of the new 5° abutment with that of the predicate devices.
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.
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
JAN 2 2 2014
Image /page/0/Picture/2 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and appear to be slightly distressed, with some small imperfections and variations in the thickness of the lines. The overall impression is of a strong, established brand name.
SECTION 5.
510(k) SUMMARY
for
ANKYLOS® SynCone® Abutment 5°
DENTSPLY Internationa
World Headquarters Susquehanna Commerce Cente 22 1- West Philadelphia Street Suite 60W York, PA 17401 (800) 877-0020 Fox (717) 849-4343 www.dentsply.com
-Submitter Information:
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
| Contact Person: | :
Helen Lewis
|
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| . " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
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ﺗ
Telephone Number:
. " | 717-487-1332 |
| 1
Fax Number: |
I
717-849-4343 |
Date Prepared:
ં તે Device Name:
- ANKYEOS® SynCone Abutinent 59 Proprietary Name:
December 20 .. 2013
Classification Name: Endosseous dental implant abutment 872:3630
- CFR Number:
- ([
- Device Class: NIJA Product Code:
ි ද Predicate Device:
- ANKYLOS SynCone® Abutinents 4º and 6° cleared as part of the a ANKYLOS® Dental Implant System (K041509)
- Angled ANKYLOS® Balance Base Abutments (K122268)
, 4 Description of Device:
The ANK YLOS® SynCone Abutiment 5° is an endosseous dental implant abutment which provides a platform for prosthetic restoration in conjunction with ANKYLOS™ implants. The subject device incorporates an abutment head with a 5° conical taper and is provided in angulations of 0° 7.5° 15° 22.5° and 30° and with gingival heights ranging from J.5mm . 4.5mm. The abutment is connected to the corresponding iniblant. by a central screw which mates with the internal thread of the implant. The abuiment and the abutment screw are machined from Titanium Alloy (Ti6AL4V ELI) conforming 10 ASTM F136 (Standard Specification for Wrought Titannum-6 Aluminim-4 Vanadium ELI (Extra Low Interstitial' Alloy for Surgical Implant Applications). The tapered SynCone® 5° caps which anchor the SynCone® abutment on the fixed denture are made of Gold Alloy of Titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The SynCone® abutments feature a
1
reatining screw design which allows for the rotation of the abutment head after attachment to the implant in order to achieve rotational alignment for all of the abutments used in the prosthetic restoration.
The DENTSPLY SynCone® Abutments are intended for use with the implants of the DENTSPLY ANKYLOS® Dental Implant System (ANKYLOS® plus, ANKYLOS® C/X implants).
In addition to the introduction of the ANKYLOS® SynCone® Abutment 5°, a modification to the indications for use statements of the currently marketed ANKYLOS® SynCone® Abutments 4° and 6° (originally cleared in premarket notification K041509, ANKYLOS Dental Implant System) is implemented as part of this premarket notification.
ഗ Indications for Use:
Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants.
Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally.
Description of Safety and Substantial Equivalence: 6.
Technological Characteristics.
The material used for the ANKYLOS® SynCone® Abutments 5°, Ti6Al4V, is the same Titanium Alloy material as is used in the legally marketed predicate device. The proposed devices are similar in terms of design, angulations, sizes, indications for use and incorporate the same technological characteristics as the predicate devices. The design of the caps and the abutment cover screw corresponds to the abutments. The materials of composition for these accessory components are equivalent to existing, legally marketed accessory components and and the biocompatibility has been evidenced.
In order to assure safety of the ANKYLOS® SynCone® Abutments 5°, a failure mode, effect and criticality analysis has been performed. There were no unacceptable risks regarding the function of the ANKYLOS® SynCone® Abutments 5°.
Non-Clinical Performance Data.
Representative fatigue testing was conducted on the subject ANKYLOS® SynCone® Abutments 5° in comparison to the predicate device. The testing was conducted according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous detnal implants) and the results support substantial equivalence.
Pull force testing was conducted to verify the equivalence of the taper friction retention properties of the SynCone® Abutment 5° in comparison with those of the predicate
2
abutments. The results confirmed the equivalence of the performance of the new 5° abutment with that of the predicate devices.
Conclusion as to Substantial Equivalence
Based on the comparison of the indications for use, the technological characteristics and the nonclinical testing, it can be concluded that the ANKYLOS® SynCone® Abutments 5° are substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three abstract human figures, with their arms raised in a gesture of support or assistance. The figures are depicted in a stylized manner, with flowing lines that suggest movement and energy.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609
Silver Spring, MD 20993-0002
Public Health Service
January 22, 2014
Dentsply International, Incorporated Ms. Helen Lewis Director Regulatory Affairs 221 West Philadelphia St. Suite 60 York, PA 17404 US
Re: K131644
Trade/Device Name: Ankylos syncone abutment 5(degree) Regulation Number: 21 CFR 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 23, 2013 Received: June 5, 2013
Dear Helen 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. 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
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Page 2 - Helen Lewis
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows the name "Kwame O. Ulmer-S" in a bold, sans-serif font. The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-S" on the bottom line. The background of the image appears to have some noise or texture, possibly from a scan or low-resolution image.
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): દિવાદા દિવસ
Device Name: ANKYLOS® SynCone® Abutment 5°
Indications for Use:
SynCone® Abutments on osseointegrated Implants Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants
SynCone® Abutments for immediate loading
Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11 mm in length and placed interforaminally.
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)
Mary S. Runner -
5
Susan Rumen DDS, MA 2014.01.21
16:29:22-05'00'
Premarket Notification
ANK YLOS* SynCone" Abutment 50
DENTSPLY. International
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