(94 days)
No K/DEN numbers found in the "Predicate Device(s)" section.
Not Found
No
The provided 510(k) summary describes a dental restorative material and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "restorative material" and is used for repairing and restoring damaged biological tissues (enamel, dentine, pulp, root perforations, etc.), which are therapeutic actions.
No
The provided text describes the Biodentine's intended uses as a restorative and repair material for teeth (crown and root), including procedures like pulp capping and apexification. These are treatment-oriented applications, not diagnostic ones.
No
The intended use describes a material used for dental restorations and procedures, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed directly on a patient's teeth (crown and root). These are therapeutic and restorative applications within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro).
The description clearly indicates the device is used within the body for dental restoration and repair, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
When used in the crown:
- Temporary enamel restorative material.
- Permanent dentine restorative material.
- Restoration of deep and/or large coronal carious lesions (sandwich technique).
- Restoration of deep cervical and/or radicular lesions.
- Pulp capping.
- Pulpotomy.
When used 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).
Biodentine is not to be used for permanent obturation or sealing of the root canal
Product codes
KIF, EJK
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Crown (refers to teeth), Root (refers to teeth)
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3820 Root canal filling resin.
(a)
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.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Septodont C/O Mr. Wayne Matelski, Esq. Official Correspondent Arent Fox, L.L.P. 1050 Connecticut Avenue, Northwest Washington, DC 20036-5339
OCT 8 0 2009
Re: K092251 Trade/Device Name: Biodentine™ Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Codes: KIF and EJK Dated: October 21, 2009 Received: October 22, 2009
Dear Mr. Matelski:
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.
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- Mr. Matelski
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement I.
Indications for Use
510(K) Number: K092251
Device Name: Biodentine™M
Indications for Use:
When used in the crown:
- Temporary enamel restorative material. ◆
- Permanent dentine restorative material. �
- Restoration of deep and/or large coronal carious lesions (sandwich technique). .
- Restoration of deep cervical and/or radicular lesions. .
- � Pulp capping.
- Pulpotomy. .
When used 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). .
Biodentine is not to be used for permanent obturation or sealing of the root canal
AND/OR » Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K092251