(738 days)
984104, 992937
Not Found
No
The summary describes a physical dental implant made of titanium and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a dental implant used to restore a patient's chewing function, which is a therapeutic intervention.
No
The provided text describes a dental implant used for restoration and does not mention any diagnostic capabilities or functions.
No
The device description clearly states the device is a physical dental implant made of titanium, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health. Examples include blood tests, urine tests, and tissue biopsies.
- This device is an implant. It is surgically placed into the human body to replace a missing tooth root and support a prosthetic. It does not analyze or test any bodily fluids or tissues in vitro (outside the body).
The description clearly states its purpose is to provide a "root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function." This is a therapeutic and restorative function, not a diagnostic one.
N/A
Intended Use / Indications for Use
"An endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants"
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Ankylos dental implants consist of uncoated pure titanium (grade 2 per ISO 5832/II). The threaded area features a rough structure, the cervical margin is polished. The implants come packaged in a sterile double glass container for contact-free handling. The cover screw has already been mounted in the implant and is only removed prior to placing the abutment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches, anterior mandible
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)
Not Found
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.
984104, 992937
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
AUG 2 2 2003
510k Summary September 12, 2002
Applicant's Name and Address:
Dentsloy Ceramco 6 Terri Lane Burlington, NJ 08016 Fax: 609-386-8282 Contact Person: Thomas B. Cameron, Dir. Q. A.
Name of Device:
Classification Name: Common / Usual Name: Proprietary Name: Establishment Registration Number: Owner - Operator: Classification;
Implant, Endosseous Dental Implant Ankylos 1225486 2246968 Class III
Predicate Devices
Straumann ITI Implant (510k - 984104) Branemark System (510k - 992937)
Description of Device
Ankylos dental implants consist of uncoated pure titanium (grade 2 per ISO 5832/II). The threaded area features a rough structure, the cervical margin is polished. The implants come packaged in a sterile double glass container for contact-free handling. The cover screw has already been mounted in the implant and is only removed prior to placing the abutment.
Intended Use of the Device
An endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2003
Mr. Thomas B. Cameron Director, Quality Assurance Dentsply Ceramco 6 Terri Lane, Suite 100 Burlington, New Jersey 08016
Re: K012681
Trade/Device Name: Ankylos Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 28, 2003 Received: June 2, 2003
Dear Mr. Cameron:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 -- Mr. Cameron
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Swertfump
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use:
K012681 510(k) Number (if known):
Device Name: __
Ankylos Implant System
Indications for Use:
An endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants"
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801, 109)
(Optional Format 1-2-96)
Kain Muley La WSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K012681