(170 days)
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
Interlig is a structure of intertwined glass fibers pre-impregnated with light-cured composite resin.
The provided document K123823 is a 510(k) summary for a dental device called "Interlig," a glass fiber reinforcement material. The document primarily focuses on establishing substantial equivalence to a predicate device ("Splint It" K972985) and does not contain information on detailed acceptance criteria or a specific study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy.
The document states:
- "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."
- "Based on the information provided in this premarket notification, we can conclude that Interlig is as safe and effective as the predicated device."
This 510(k) submission relies on demonstrating similarity to a previously cleared device rather than presenting a de novo performance study with specific acceptance criteria and results for the new device. Therefore, I cannot provide the requested information.
However, based on the type of document, I can infer what would typically be presented for such a submission if a new performance study were conducted. Since it is not present in the given text, I will state explicitly that the following is not found in the document.
Information NOT Found in the Provided Document:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set and data provenance.
- Number of experts used to establish ground truth for a test set and their qualifications.
- Adjudication method for a test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Conclusion:
The provided 510(k) summary for K123823 does not contain the detailed performance study information requested. It establishes substantial equivalence to a predicate device (Splint It K972985) based on similar intended use, technical characteristics, indications for use, materials, form factor, performance, and safety characteristics. No specific performance metrics, acceptance criteria, or study results proving such criteria directly for the Interlig device are presented in this document.
{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
§ 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.