(79 days)
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.
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 provided text describes the regulatory clearance of a dental implant system and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or technical study setup.
The submission is an "Abbreviated 510(k)," meaning it relies on demonstrating conformity with FDA guidance documents and substantial equivalence to predicate devices rather than presenting new performance data from a dedicated study.
Therefore, I cannot fulfill the request for information regarding:
- A table of acceptance criteria and reported device performance: This type of data is not present in the provided document.
- Sample size used for the test set and data provenance: No test set is described.
- Number of experts used to establish ground truth and qualifications: No ground truth establishment process is described.
- Adjudication method: Not applicable as no test set or ground truth establishment is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical dental device, not an algorithm.
- Type of ground truth used: Not applicable as no ground truth is established.
- Sample size for the training set: Not applicable as this is a physical device, not a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
The document focuses on the regulatory process for enabling the marketing of the device based on its substantial equivalence to previously approved devices and adherence to relevant guidance documents.
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| Establishment: | Intra-Lock International, Inc.6560 West Rogers CircleSuite 24Boca 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 ImplantSystems | Intra-LockInternational | 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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§ 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.)