(90 days)
Not Found
No
The summary describes a standard dental implant system with surgical and restorative components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies section refers to conformity with existing guidance documents for dental implants, not validation of an AI/ML algorithm.
No.
The device is a dental implant system designed to restore missing teeth, which is a restorative rather than a therapeutic function.
No
Explanation: The device is an implant system designed to restore edentulous patients, not to diagnose a condition.
No
The device description clearly outlines physical components such as dental implants, restorative components, surgical drills, instruments, and trays, indicating it is a hardware-based medical device system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to restore partially or fully edentulous patients by supporting removable or fixed prostheses. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device consists of dental implants, restorative components, and surgical instrumentation. These are all physical devices used in a surgical and prosthetic context.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the examination of specimens outside the body.
The device is clearly a dental implant system, which is a type of medical device used for surgical implantation and prosthetic restoration within the oral cavity.
N/A
Intended Use / Indications for Use
The Intra-Lock Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.
Product codes
DZE
Device Description
The Intra-Lock International Dental Implant System consists of root form dental implants and restorative components which provide the clinician with screw retained and removable overdenutre This system also includes prosthetic instrumentation, surgical drills, hand type restorative options. instruments, surgical trays and handpiece adapters for use in the surgical procedures. The implants are sterile packaged and include cover screws and a placement instrument. Prosthetic devices are packaged separately to allow the clinician to choose the appropriate means for restoration after osseointegration. Implant bodies are subjected to a surface treatment of blasting with resorbable blast media and then acid passivation to roughen the surface.
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)
This submission is a Special 510(k): Abbreviated 510(k) as described in FDA 's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Intra-Lock has provided information to demonstrate conformity with FDA's guidance document entitled: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K944683, K945398, K950624, K003226, K994104
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 2 4 2002
510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, International is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Intra-Lock International chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | Intra-Lock System |
|---|---|
| Sponsor: | Intra-Lock International |
| 1200 North Federal Highway | |
| Suite 200 | |
| Boca Raton, FL 33432 | |
| Registration No.: 3003631996 | |
| Device Generic Name: | Dental Implants |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class III. |
Predicate Devices:
| Branemark Dental Implant System | K944683 |
|---|---|
| Branemark MkII Dental Implants | K945398 |
| Lifecore Self Tapping Implants | K950624 |
| Lifecore Stage 1 RBM Implants | K003226 |
| ITI Strauman One Part Implants | K994104 |
Product Description:
The Intra-Lock International Dental Implant System consists of root form dental implants and restorative components which provide the clinician with screw retained and removable overdenutre This system also includes prosthetic instrumentation, surgical drills, hand type restorative options. instruments, surgical trays and handpiece adapters for use in the surgical procedures. The implants are sterile packaged and include cover screws and a placement instrument. Prosthetic devices are packaged separately to allow the clinician to choose the appropriate means for restoration after osseointegration. Implant bodies are subjected to a surface treatment of blasting with resorbable blast media and then acid passivation to roughen the surface.
Indications for Use:
The Intra-Lock Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the maxilla and to support removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.
1
Safety and Performance:
This submission is a Special 510(k): Abbreviated 510(k) as described in FDA 's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Intra-Lock International has provided information to demonstrate conformity with FDA's guidance document entitled: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Intra-Lock Dental Implant System has been shown to be safe and effective for its intended use.
Image /page/1/Picture/4 description: In this image, there is a blurry stamp that says "RECEIVED" and "JUL 16". The stamp is tilted at an angle. The text is in black ink.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 2002
Mr. Jeffery Sakoff Director of Operations Intra-Lock International 1200 N. Federal Highway, Suite 200 Boca Raton, Florida 33432
Re: K021322
Trade/Device Name: Intra-Lock Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: April 19, 2002 Received: April 25, 2002
Dear Mr. Sakoff:
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.
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.
3
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of of 1 a
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Intra-Lock Dental Implant System Device Name:
Indications for Use:
The Intra-Lock Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the -Counter Use
Robert S. Betz, DDS for Dr. Susan Renner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital, Innection Con 510(k) Number _ KO2