(79 days)
Not Found
No
The document describes a dental implant system and its components, with no mention of AI or ML technology.
No.
The device, a dental implant system, is designed to restore missing teeth and support prosthetics, which is a structural and restorative function, not a therapeutic treatment for a disease or medical condition.
No
Explanation: The device is described as an implant system prosthetics (abutments) designed to restore partially or fully edentulous patients. Its purpose is restoration, not diagnosis.
No
The device description explicitly states the device consists of physical components made of Titanium 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 to restore partially or fully edentulous patients using dental implants and prosthetics. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device consists of dental implants and abutments made of titanium alloy. These are physical components implanted into the bone to support prosthetics.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a restorative purpose.
N/A
Intended Use / Indications for Use
The Intra-Lock Mini Drive Lock™ Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.
Product codes
NIHA
Device Description
The Intra-Lock Mini Drive-Lock™ Dental Implant System Prosthetics consist of straight and angled cement retained abutments in various sizes. There are also provisions on the implants for overdenture retention abutment allowing for tissue born or combination tissue and tooth born removable prosthetic appliances. The prosthetics allow for full arch restorations, for either fixed or removable prosthetic appliances. The abutment raw materials consist of Titanium Alloy for Surgical Implant Applications (as per ASTM F 136) Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy. The abutment components are non sterile packaged.
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
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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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.)
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| Establishment: | Intra-Lock International, Inc.
6560 West Rogers Circle
Suite 24
Boca Raton, FL 33487 | | MAY 21 2008 |
|-------------------|-----------------------------------------------------------------------------------------------|--|-------------|
| Proprietary Name: | Mini Drive-LockTM Dental Implant System Prosthetics | | |
Classification Name: Endosseous Dental Implant Abutments (21 CFR 872.3630)
Device Classification: Class II
Predicate Devices:
| Predicate Device List | |||||
|---|---|---|---|---|---|
| Product Name | Company | 510(k) | |||
| Intra-Lock Dental Implant | |||||
| Systems | Intra-Lock | ||||
| International | K021322 |
- Device Description: The Intra-Lock Mini Drive-Lock™ Dental Implant System Prosthetics consist of straight and angled cement retained abutments in various sizes. There are also provisions on the implants for overdenture retention abutment allowing for tissue born or combination tissue and tooth born removable prosthetic appliances. The prosthetics allow for full arch restorations, for either fixed or removable prosthetic appliances. The abutment raw materials consist of Titanium Alloy for Surgical Implant Applications (as per ASTM F 136) Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy. The abutment components are non sterile packaged.
- The Intra-Lock Mini Drive Lock™ Implant System Prosthetics Intended Use: have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.
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- This submission is an Abbreviated 510(k) as described Safety and Performance: 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 Endosseous Implant Abutments 872-3630. In addition, the FDA Guidance Document for Root Form Endosseous Implants, 872-3640 was also consulted during our preparation of this application for permission to market these products.
- Based on the indications for use, technological Conclusion: characteristics, and comparison to predicate devices, the Intra-Lock Mini Drive-Lock" Implant System Prosthetics have been shown to be safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2008
Mr. Jeffrey Sakoff Director of Operations Intra-Lock International 6560 West Rogers Circle, Suite 24 Boca Raton, Florida 33487
Re: K080598
Trade/Device Name: Mini Drive-Lock" Dental Implant System Prosthetics Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NIHA Dated: February 27, 2008 Received: March 4, 2008
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.
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Page 2- Mr. Sakoff
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Suite Y. McRae Davis
Chiu Lin, Ph.D. 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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Indications for Use
12080598 510(K) Number (if known):
Device Name: Mini Drive-Lock™ Dental Implant System Prosthetics
Indications for Use:
The Intra-Lock Mini Drive Lock™ Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over the Counter Use (21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Dunne
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K080548
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