(170 days)
Not Found
No
The device description and intended use do not mention any computational or analytical capabilities, focusing solely on the material composition and structural application.
No
The device is described as a material used for various dental applications like splinting, reinforcing, and acting as a matrix, but its intended use does not involve treating or curing any disease or condition, which is characteristic of a therapeutic device. It is primarily a structural aid in dentistry.
No
The device description and intended uses clearly state that Interlig is a material used for various dental procedures like splinting, reinforcing, and acting as a matrix or space maintainer. These are therapeutic and restorative functions, not diagnostic ones.
No
The device description explicitly states it is a "structure of intertwined glass fibers pre-impregnated with light-cured composite resin," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Interlig's Intended Use: The intended uses listed for Interlig are all related to mechanical support and reinforcement of teeth and dental prosthetics within the mouth. This is a direct application to the patient's anatomy, not the analysis of samples taken from the patient.
- Device Description: The description of Interlig as a structure of glass fibers and composite resin further supports its role as a structural material for dental applications, not a diagnostic tool.
Therefore, Interlig falls under the category of a dental device used for treatment and support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Interlig is indicated for:
- Splinting periodontal involved and mobile teeth to prevent movement
- To reinforce full denture and partial denture repairs
- As a matrix between abutment teeth for receiving a temporary replacement tooth
- As an aid in the reinforcement of temporary crowns and bridge work
- As a space maintainer for orthodontic involved teeth
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Interlig is a structure of intertwined glass fibers pre-impregnated with light-cured composite resin.
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
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.
Splint It K972985
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Angelus Science and Technology. The logo consists of a black circle with a white triangle inside, followed by the word "angelus" in black lowercase letters. Below the word "angelus" is the phrase "science and technology" in smaller, lighter letters.
MAY 3 1 2013
SECTION 9
510 (K)SUMMARY OF SAFETY AND EFFECTIVENESS
Proprietary Name
Interlig
Date Prepared
May 1, 2013
Submitter
Angelus Industria de Productos Odontologicos Waldir Landgraf, 101 Londrina, Brazil 86031-3200
Telephone: +55 43 2101 3200
Official Contact
Tara Conrad TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180 TEL- (305) 377-0077
Common Name
Glass fiber reinforcement material
Classification Name
Regulation Number & Product Codes
Proposed Requiatory Class
Predicate Device Identification
Tooth Shade Resin Material
EBF - 872.3690
Class II
Splint It K972985
1
Image /page/1/Picture/0 description: The image shows the logo for Angelus Science and Technology. The logo features a black circle with a white triangle inside, followed by the word "angelus" in a stylized font. Below the word "angelus" are the words "science and technology" in a smaller font.
Description of Proposed Device
Interlig is a structure of intertwined glass fibers pre-impregnated with light-cured composite resin.
Indications for Use
Interlig is indicated for:
- Splinting periodontal involved and mobile teeth to prevent movement
- To reinforce full denture and partial denture repairs
- As a matrix between abutment teeth for receiving a temporary replacement tooth
- As an aid in the reinforcement of temporary crowns and bridge work
- As a space maintainer for orthodontic involved teeth
Substantial Equivalence
Interlig has the same intended use and similar technical characteristics as Splint It K972985. The indications for use, materials, form factor, performance and safety characteristics between Interlig and Splint It are the same.
Conclusion
Based on the information provided in this premarket notification, we can conclude that Interlig is as safe and effective as the predicated device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2013
Angelus Industria de Productos Odontologicos C/O Ms. Lilian Llull TechLink International Consulting 18851 North East, 29th Avenue Suite 720 AVENTURA FL 33180
Re: K123823
Trade/Device Name: Interlig Regulation Number: 21 CFR 872.3690 Regulation Name: Endodontic Stabilizing Splint. Regulatory Class: II Product Code: EBF Dated: May 1, 2013 Received: May 2, 2013
Dear Ms. Llull:
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-interstatecommerce 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.
3
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
Sincerely yours.
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Kwame O. Ulmer
S FLA
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Interlig is indicated for: 11/23823
-
Splinting periodontal involved and mobile teeth to prevent movement
-
To reinforce full denture and partial denture repairs
-
As a matrix between abutment teeth for receiving a temporary replacement tooth
-
As an aid in the reinforcement of temporary crowns and bridge work
-
As a space maintainer for orthodontic involved teeth
_ (Part 21 CFR 801 SubpartD) AND/OR Prescription Use _ × _ (21 CFR 801 Subpart C) Over-The-Counter Use (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Image /page/4/Picture/9 description: The image shows a signature and some text. The signature reads "Susan Runner, DDSMA". Below the signature is the text "Digitally signed by Mary S. Runner-5". Additional text includes information about the digital signature, such as "c=US, o=U.S. Government, ou=HHS, ou=FOA, ou=People, cn=Mary S. Runner-5" and a date and time stamp: "Date: 2013.05.31 09:17:49-04'00".
slotogy, General Hospital
510(k) Number: K125062
K123823 Additional Information Request