BIODENTINE

K140132 · Septodont · KIF · Jun 27, 2014 · Dental

Device Facts

• Record ID: K140132
• Device Name: BIODENTINE
• Applicant: Septodont
• Product Code: KIF · Dental
• Decision Date: Jun 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biodentine™ is indicated to be used: In the crown: - Permanent dentine restoration under composites or Inlay/Onlay - Temporary dentine-enamel restoration. - Restoration of deep and/or large coronal carious lesions (sandwich technique). - Restoration of cervical radicular lesions. - Pulp capping. - Pulpotomy. In the root: - Repair of root perforations. - Repair of furcation perforations. - Repair of perforating internal resorptions. - Repair of external resorption - Apexification. - Root-end filling in endodontic surgery (retrograde filling).

Device Story

Biodentine is a dental material used by dentists for restorative and endodontic procedures. It functions as a dentine substitute for crown restorations (permanent or temporary) and as a repair material for root-related pathologies including perforations, resorptions, and apexification. It is applied directly to the tooth structure or root canal system by a clinician. The material facilitates clinical decision-making by providing a biocompatible barrier for pulp protection and structural repair of the tooth, potentially preserving tooth vitality and preventing extraction.

Clinical Evidence

No clinical data provided; device cleared based on bench testing and substantial equivalence to legally marketed predicate devices.

Technological Characteristics

Dentine substitute material; chemical composition and physical properties consistent with root canal filling materials (21 CFR 872.3820).

Indications for Use

Indicated for dental patients requiring coronal dentine restoration, pulp capping, pulpotomy, or endodontic root repair (perforations, resorptions, apexification, or root-end filling).

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

## 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

## June 27, 2014

Septodont C/O Ms. Cora Bracho-Troconis Director of Scientific and Regulatory Affairs 416 S. Taylor Ave Louisville, CO 80027

Re: K140132

Trade/Device Name: Biodentine Regulation Number: 21 CFR 872.3820 Regulation Name: Resin, Root Canal Filling Regulatory Class: II Product Code: KIF. EMA Dated: June 4, 2014 Received: June 6, 2014

Dear Ms. Bracho-Troconis:

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 notc: 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.

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## Page 2 - Ms. Bracho-Troconis

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Erin 1. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 004: Indications for Use Statement

(As Required by 21 CFR § 807.87)

510(k) Number:

Device Name: Biodentine™

Indications for Use:

Biodentine™ is indicated to be used:

In the crown:

- Permanent dentine restoration under composites or Inlay/Onlay

- Temporary dentine-enamel restoration.

- Restoration of deep and/or large coronal carious lesions (sandwich technique).

- Restoration of cervical radicular lesions.

- Pulp capping.

- Pulpotomy.

In the root:

- Repair of root perforations.
- Repair of furcation perforations.

- Repair of perforating internal resorptions.

- Repair of external resorption

- Apexification.

- Root-end filling in endodontic surgery (retrograde filling).

× Prescription Use (Part 21 CFR 801 Subpart D). AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael E. Adjodha -S 2014.06.27 10:01:39 -04'00'

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