← Product Code [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF) · K123823 # INTERLIG (K123823) _Angelus Industria DE Productos Odontologicos · EBF · May 31, 2013 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K123823 ## Device Facts - **Applicant:** Angelus Industria DE Productos Odontologicos - **Product Code:** [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF.md) - **Decision Date:** May 31, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3690 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended 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 ## Device Story Interlig is a dental reinforcement material consisting of intertwined glass fibers pre-impregnated with light-cured composite resin. Used by dental professionals in clinical settings to provide structural support for mobile teeth, denture repairs, temporary prosthetics, and orthodontic space maintenance. The material is applied to the dental site and cured using a light source to harden the resin, creating a rigid splint or reinforcement structure. This stabilizes mobile teeth, strengthens dental repairs, or maintains space for orthodontic purposes, ultimately improving patient dental function and prosthetic longevity. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Glass fiber reinforcement material pre-impregnated with light-cured composite resin. Form factor is a fiber structure. Energy source required for curing is a dental light-curing unit. ## Regulatory 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. ## Predicate Devices - Splint It ([K972985](/device/K972985.md)) ## Related Devices - [K972985](/device/K972985.md) — SPLINT IT · Jeneric/Pentron, Inc. · Sep 24, 1997 - [K063170](/device/K063170.md) — TENDER FIBER · Micerium S.P.A. · Jan 12, 2007 - [K102207](/device/K102207.md) — FIBER FORCE · Synca Marketing, Inc. · Nov 23, 2010 - [K053328](/device/K053328.md) — BIOSPLINT SPLINTING RIBBON · Satelec · Jan 25, 2006 - [K082180](/device/K082180.md) — PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 · Angelus Industria DE Productos Odontologicos · Dec 17, 2008 ## Submission Summary (Full Text) {0}------------------------------------------------ K123823 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K123823](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K123823) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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