(190 days)
Not Found
No
The summary describes a dental implant, a physical device, and the testing performed is mechanical fatigue testing and CAD analysis. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is a dental implant intended to restore chewing function, which is a therapeutic purpose.
No
The device is an endosseous dental implant designed to restore chewing function, not to diagnose a medical condition or disease.
No
The device description explicitly states it is an "endosseous dental implant" machined from titanium, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure to restore chewing function by placing dental implants in the jawbone. This is a direct medical intervention on a patient's body.
- Device Description: The device is described as an endosseous dental implant made of titanium, designed to be surgically placed.
- Lack of IVD Characteristics: 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.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a medical implant.
N/A
Intended Use / Indications for Use
ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.
ANKYLOS® C/X Implants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The ANKYLOS® C/X Implant 6.6 mm represents a line extension of the currently marketed ANKYLOS® C/X Dental Implant System. It is an endosseous dental implant with a length of 6.6 mm and an internal tapered implant-abutment connection. The ANKYLOS® C/X Implant 6.6 mm is machined from Commercially Pure (CP) Grade 2 Titanium (conforming to ASTM F67 -Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The ANKYLOS C/X 6.6 mm implants are provided in the diameters 3.5 mm, 4.5 mm, and 5.5 mm.
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)
Non-Clinical Performance Data.
Fatigue testing was conducted on the subject ANKYLOS® C/X Implant 6.6 mm in comparison to the predicate device according to ISO 14801 (Dentistry - Implants -Dynamic fatigue test for endosseous dental implants). Further, surface area and bone to implant contact have been calculated by CAD data for the ANKYLOS® C/X Implant 6.6 mm and the predicate device, respectively. The results support substantial equivalence.
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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 an abstract symbol resembling a stylized human figure, with three overlapping profiles facing to the right. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2014
Dentsply International, Inc. Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 York, PA 17404
Re: K140347
Trade/Device Name: ANKYLOS® C/X Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE Dated: July 21, 2014 Received: July 23, 2014
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
Page 2 - Ms. Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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,
Mary S. Runner -S
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
510(k) Number (if known):
Device Name: ANKYLOS® C/X Implant System
Indications for Use:
ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.
ANKYLOS® C/X Implants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.
X = 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
SECTION 5. 510(k) SUMMARY
for ANKYLOS® C/X Implant System
Submitter Information: 1.
DENTSPLY International, Inc. 221 West Philadelphia Street, Suite 60 York, PA 17404
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
Date Prepared: February
-
Device Name: 2.
. -
Proprietary Name:
-
Classification Name: .
-
CFR Number: ●
-
Device Class: ●
-
Product Code: DZE ●
3. Predicate Device:
- ANKYLOS® C/X Dental Implant System cleared in K083805 ●
872.3640
II
- . Bicon Implant 4.0 x 5.0 mm cleared in K092035 (Bicon Implants with a 2.5 mm Internal Connection)
ANKYLOS® C/X Implant System
Endosseous dental implant
4. Description of Device:
The ANKYLOS® C/X Implant 6.6 mm represents a line extension of the currently marketed ANKYLOS® C/X Dental Implant System. It is an endosseous dental implant with a length of 6.6 mm and an internal tapered implant-abutment connection. The ANKYLOS® C/X Implant 6.6 mm is machined from Commercially Pure (CP) Grade 2 Titanium (conforming to ASTM F67 -Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The ANKYLOS C/X 6.6 mm implants are provided in the diameters 3.5 mm, 4.5 mm, and 5.5 mm.
- న. Indications for Use:
ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or twostage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.
ANKYLOS® C/X 1mplants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X
4
lmplants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.
Description of Safety and Substantial Equivalence: 6.
Technological Characteristics.
The material used for the ANKYLOS® C/X Implant 6.6 mm is the same CP Grade 2 titanium material as is used in the legally marketed predicate device, ANKYLOS C/X Dental Implant System (K083805). The proposed devices are similar in terms of design, sizes, indications for use and incorporate the same technological characteristics as the predicate devices (see Table 1).
In order to assure safety of the ANKYLOS® C/X Implant 6.6 mm, a Failure Mode, Effects Analysis has been performed. There were no unacceptable risks regarding the function of the ANKYLOS® C/X Implant 6.6mm.
Non-Clinical Performance Data.
Fatigue testing was conducted on the subject ANKYLOS® C/X Implant 6.6 mm in comparison to the predicate device according to ISO 14801 (Dentistry - Implants -Dynamic fatigue test for endosseous dental implants). Further, surface area and bone to implant contact have been calculated by CAD data for the ANKYLOS® C/X Implant 6.6 mm and the predicate device, respectively. The results support substantial equivalence.
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® C/X Implant 6.6 mm is substantially equivalent to the predicate devices.
5
| Table 1: Similarities and Differences between the proposed and the predicate devices | |||
|---|---|---|---|
| Proposed Device | Predicate Device | Predicate Device | |
| DENTSPLY ANKYLOS® C/X Implant System | DENTSPLY ANKYLOS® C/X Implant | ||
| System | |||
| (K083805) | Bicon Implant 4.0 x 5.0mm | ||
| (K092035) | |||
| Indications for use | ANKYLOS® C/X Implants of 8mm in length or longer are for | ||
| single-stage or two-stage surgical procedures and cemented, | |||
| removable or screw retained restorations. The ANKYLOS® C/X | |||
| Implants may be used for immediate placement and function on | |||
| single tooth and/or multiple tooth applications when adequate | |||
| primary stability is achievable, with appropriate occlusal | |||
| loading, in order to restore chewing function. Multiple toothapplications may be splinted. | The ANKYLOS® C/X Implant System is | ||
| for single-stage or two-stage surgical | |||
| procedures and cemented or screw | |||
| retained restorations. The ANKYLOS® | |||
| C/X Implant System is intended for | |||
| immediate placement and function on | |||
| single tooth and/or multiple tooth | |||
| applications when good primary stability | |||
| is achieved, with appropriate occlusal | |||
| loading, in order to restore chewing | |||
| function. Multiple tooth applications may | |||
| be splinted with a bar. | The Bicon implant is designed | ||
| for use in edentulous sites in the | |||
| mandible or maxilla for support | |||
| of a complete denture prosthesis, | |||
| a final or intermediate abutment | |||
| for fixed bridgework or for | |||
| partial dentures, or as a single | |||
| tooth replacement. | |||
| ANKYLOS® C/X Implants of 6.6mm in length are for two- | |||
| stage surgical procedures and cemented, removable or screw | |||
| retained restorations. The ANKYLOS® C/X Implants may be | |||
| used for immediate placement on single tooth and/or multiple | |||
| tooth applications when adequate primary stability is achievable, | |||
| with appropriate occlusal loading, in order to restore chewing | |||
| function. Multiple tooth applications may be splinted. | |||
| Material | |||
| Composition | Commercially Pure Titanium | Commercially Pure Titanium | Titanium Alloy |
| Implant-Abutment | |||
| Connection | tapered | tapered | tapered |
| Implant | |||
| Design / | Thread | Thread | Plateau Design |
| Diameter | |||
| (mm) | 3.5/4.5/5.5/6.5 | 3.5/4.5/5.5/6.5 | 4 mm |
| Length (mm) | 6.6/8/9.5/11/14/17 | 8/9.5/11/14/17 | 5.0 |
| Delivery | sterile | sterile | sterile |
Table 1: Similarities and Differences between the proposed and the predicate devices