(171 days)
Not Found
No
The description focuses on a mechanical lock-release system for attaching a prosthetic device, with no mention of AI or ML technologies.
No
The device is described as an attachment system for removable prosthetic devices to endosseous implants. Its function is to provide a mechanical means for retention, not to treat or cure a disease or condition.
No
The device is described as an attachment system for removable prosthetic devices, focusing on mechanical retention and ease of manipulation, not on diagnosing medical conditions.
No
The device description explicitly details physical components like "ball abutments," "cone shaped" abutments, a "reciprocal cover in the denture base," and a "mechanical lock/release action activated by digital pressure." It also mentions "metal female counterpart" and "buttons" of the lock/release mechanism. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a means of attaching a removable prosthetic device to an endosseous implant body. This is a mechanical function performed in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a mechanical attachment system for dental prosthetics. It focuses on the physical mechanism of attachment and release.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies mentioned are related to ease of handling in vivo and biocompatibility in vitro (which is a standard test for medical devices, not specific to IVDs). There are no studies related to diagnostic accuracy or performance.
In summary, the LRT Attachment System is a medical device used for a prosthetic application within the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The LRT Attachment System is indicated for providing a mean of attaching a removable prosthetic device to an endosseous implant body.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Alike the Locator implant, the O-ring Prosthetic Attachment and the Nobel Ball Attachment systems, the LRT Attachment System provides a mean for attaching a removable prosthetic device to an endosseous implant body with the use of a mechanical based retention, hence eliminating permanent structures that prevent easy access to implant abutments.
The LRT Attachment System requires the use of two ball abutments to receive the The presence of additional implant abutments, although not attachment. mandatory, contributes to the support and stability of the prosthesis. These abutments are cone shaped and mate with a reciprocal cover in the denture base.
All predicate devices are snap-on devices. The retentive female part is embedded in the denture part and snaps on another part (e.g. a ball abutment). The retentive action relies on the expansion and constriction of the metal female counterpart. The LRT Attachment System provides for an innovative solution by featuring a lock-release retention system activated by digital pressure. This mechanical lock/release action offers ease of manipulation. One of the key elements of the LRT Attachemt System is the easily identified "buttons" of the lock/release mechanism which allow an assistant to manipulate the denture for the severely impaired person.
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
Over 18 years of clinical testing were performed to fine tune the device and its integration to dental prostheses.
Description of the test set, sample size, data source, and annotation protocol
In these clinical tests, the LRT Attachment System was found substantially equivalent to the cited predicates. Furthermore, Cytotoxicity in-vitro screening assays in accordance with USP 87 were successfully performed to assess the biocompatibility of the material.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The activation of the mechanism to provide the lock/release function was tested in vivo to insure the ease of handling. Over 18 years of clinical testing were performed to fine tune the device and its integration to dental prostheses. In these clinical tests, the LRT Attachment System was found substantially equivalent to the cited predicates. Furthermore, Cytotoxicity in-vitro screening assays in accordance with USP 87 were successfully performed to assess the biocompatibility of the material.
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.
Locator implant anchor K994257, Ball Attachment system K955372, O-ring Prosthetic Attachment K001638
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
§ 872.3630 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.)
0
JAN 3 0 2012
510(k) Summary
| 1. | Name/Address of Submitter: | Innovation TAP inc.
1441, rue du Collège
Suite 4
Montréal, Québec
H4L 2L8 CANADA |
|----|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person: | Emmanuel Montini, Ph.D., Adm.A
Co-President, BCF Certification inc.
Phone: (514) 927-4635
Fax: (514) 397-8515
Email: emontini@bcf.ca |
| 3. | Date Summary Prepared: | July 15th, 2011 |
| 4. | Classification: | 21 CFR 872.3630 |
| 5. | Common Name: | Accessory to endosseous dental implan
abutment |
| 5. | Device Name: | LRT Attachment System |
| 6. | Product Code: | NHA |
5. Predicate Devices:
| LRT
System | Attachment | Locator implant anchor K994257
Ball Attachment system K955372
O-ring Prosthetic Attachment K001638 |
| --------------- | ------------ | ---------------------------------------------------------------------------------------------------------- |
|---|
Device Description: 6.
Alike the Locator implant, the O-ring Prosthetic Attachment and the Nobel Ball Attachment systems, the LRT Attachment System provides a mean for attaching a removable prosthetic device to an endosseous implant body with the use of a mechanical based retention, hence eliminating permanent structures that prevent easy access to implant abutments.
The LRT Attachment System requires the use of two ball abutments to receive the The presence of additional implant abutments, although not attachment. mandatory, contributes to the support and stability of the prosthesis. These abutments are cone shaped and mate with a reciprocal cover in the denture base.
All predicate devices are snap-on devices. The retentive female part is embedded in the denture part and snaps on another part (e.g. a ball abutment). The retentive
1
action relies on the expansion and constriction of the metal female counterpart. The LRT Attachment System provides for an innovative solution by featuring a lock-release retention system activated by digital pressure. This mechanical lock/release action offers ease of manipulation. One of the key elements of the LRT Attachemt System is the easily identified "buttons" of the lock/release mechanism which allow an assistant to manipulate the denture for the severely impaired person.
7. Indication for Use:
The LRT Attachment System is indicated for providing a mean of attaching a removable prosthetic device to an endosseous implant body.
- Brief Description of Clinical and Non-clinical Testing: The activation of the 8. mechanism to provide the lock/release function was tested in vivo to insure the ease of handling. Over 18 years of clinical testing were performed to fine tune the device and its integration to dental prostheses. In these clinical tests, the LRT Attachment System was found substantially equivalent to the cited predicates. Furthermore, Cytotoxicity in-vitro screening assays in accordance with USP 87 were successfully performed to assess the biocompatibility of the material.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Louis-Paul Marin Consultant BCF Certification Incorporation 1100 Rene-Levesque Boulevard, West 25th Floor Montreal CANADA H4L 2L8
Re: K112333
Trade/Device Name: LRT Attachment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 19, 2012 Received: January 23, 2012
Dear Mr. Marin:
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.
JAN 3 0 2012
3
Page 2 - Mr. Marin
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilation ification" (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 1 samall 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,
es fer Anthony Diktson
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
KII 2333
Indication for Use
510(k) Number (if known):
Device Name: LRT ATTACHMENT SYSTEM
Indication for Use: The LRT Attachment System is indicated for providing a mean of attaching a removable prosthetic device to an endosseous implant body.
Concurrence of CDRH Office of Device Evaluation
Prescription Use (per 21CFR 801.109)
: ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・
2291689.1
OR
Over-the-counter Use
Susan Gunner
510(k) Number:
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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