(172 days)
Not Found
No
The device description and performance studies focus on the material properties of a mineral trioxide aggregate cement, with no mention of AI or ML.
Yes
The device is a dental cement used for various endodontic treatments aimed at repairing and preserving dental tissues, which falls under the definition of therapeutic interventions.
No
The device is a mineral trioxide aggregate cement used for root repair during endodontic treatment, not for diagnosing conditions. Its intended uses primarily involve treatment procedures like repairing perforations, pulp capping, and apexification.
No
The device description clearly states it is a mineral trioxide aggregate cement, which is a physical material, 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 treating conditions within the human body, specifically within the teeth and surrounding structures. IVDs are used to examine specimens taken from the body (like blood, urine, tissue) to provide information about a person's health status.
- Device Description: The device is described as a cement used for root repair during endodontic treatment, which is a therapeutic procedure performed directly on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, MTA Angelus, as described, is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions
- Via canal treatment of root perforation due to internal resorption
- Surgical treatment of root perforation due to internal resorption
- Periapical surgery with reverse filling
- Pulp capping
- Pulpotomy (removal of affected coronal pulp to preserve vitality of remaining pulp tissue)
- Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp).
- Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
MTA Angelus is a mineral trioxide aggregate cement used for root repair during endodontic treatment, combining the powder and liquid produces a colloidal gel that solidifies to form a barrier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal, furcation, pulp, root tip
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)
Performance testing was conducted for setting time, solubility, radiopacity and dimensional changes to demonstrate substantial equivalence and included methods described in ISO 6876 Dental Root Canal Sealing Materials.
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.
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
§ 872.3820 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.
0
510(k) Summary
Angelus Indústria de Produtos Odontológicos S/A
MTA Angelus K112046
December 27, 2011
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Angelus Indústria de Produtos Odontológicos S/A
Rua Waldir Landgraf, 101
Londrina - PR - 86031-218
Brazil | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------|--|
| Telephone: | +55 (43) 2101-3200 | |
| Fax: | +55 (43) 2101-3201 | |
| Official Contact: | Marco Canonico
International Business Director | |
| Representative/Consultant: | Linda K. Schulz
Kevin A. Thomas
PaxMed International, LLC
11234 El Camino Real, Suite 200
San Diego, CA 92130 | |
| Telephone: | +1 (858) 792-1235 | |
| Fax: | +1 (858) 792-1236 | |
| Email: | lschulz@paxmed.com
kthomas@paxmed.com | |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | MTA Angelus |
|---|---|
| Classification Name: | Root Canal Filling Resin |
| Classification Regulations: | 21 CFR 872.3820, Class II |
| Product Code: | KIF |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
1
510(k) Summary
INTENDED USE
- . Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions
- . Via canal treatment of root perforation due to internal resorption
- . Surgical treatment of root perforation due to internal resorption
- . Periapical surgery with reverse filling
- . Pulp capping
- . Pulpotomy (removal of affected coronal pulp to preserve vitality of remaining pulp tissue)
- . Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp).
- . Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)
DEVICE DESCRIPTION
MTA Angelus is a mineral trioxide aggregate cement used for root repair during endodontic treatment, combining the powder and liquid produces a colloidal gel that solidifies to form a barrier.
EQUIVALENCE TO MARKETED DEVICE
Angelus Indústria de Produtos Odontológicos S/A demonstrated that, for the purposes of FDA's regulation of medical devices, MTA Angelus is substantially equivalent in indications and design principles to the following predicate devices:
DENTSPLY International, MTA Advanced Material cleared under K073218 and DENTSPLY International, White MTA Material cleared under K011009. DENTSPLY International, MTA Root Canal Sealer K080203
The subject device and the predicate devices have the same or similar intended use and have the same technological characteristics and are made of the same or similar materials. They encompass the same range of physical and chemical properties. The subject and predicate devices are packaged in similar materials and use similar methods of application. Any differences in the technological characteristics do not raise new issues of safety or efficacy.
Performance testing was conducted for setting time, solubility, radiopacity and dimensional changes to demonstrate substantial equivalence and included methods described in ISO 6876 Dental Root Canal Sealing Materials.
Overall, MTA Angelus has the following similarities to the predicate devices:
- has the same or similar intended use, .
- uses the same operating principle, .
- incorporates the same basic design, .
- incorporates the same or very similar materials, and .
- . has similar packaging.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Angelus Industria de Produtos Odontologicos S/A C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
JAN - 6 2012
Re: K112046
Trade/Device Name: MTA Angelus Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: December 27, 2011 Received: December 28, 2011
Dear Ms. Schulz:
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 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
Page 2 -- Ms. Schulz
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 (veparine 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
Device Name: MTA Angelus
Indications for Use:
- Treatment of perforations of root canal and furcation caused iatrogenically or by caries . lesions
- Via canal treatment of root perforation due to internal resorption .
- Surgical treatment of root perforation due to internal resorption .
- . Periapical surgery with reverse filling
- . Pulp capping
- Pulpotomy (removal of affected coronal pulp to preserve vitality of remaining pulp tissue) .
- Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp) .
- Apexification (induction of formation of a mineralized barrier at the root tip of young . permanent teeth with incomplete root development and a necrotic pulp)
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Page 1 of
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________