(86 days)
No
The summary describes a material used for root end filling and does not mention any computational or analytical capabilities, let alone AI/ML.
No.
Explanation: The device is a material used to fill root ends, which is a structural or restorative function, not a therapeutic one that treats a disease or condition.
No
Explanation: The device, MTA MATERIAL, is explicitly indicated as a "root end filling material," meaning its purpose is restorative or reparative rather than diagnostic. It does not mention detecting, diagnosing, or characterizing medical conditions.
No
The device is described as a powder that solidifies into a hard structure, indicating it 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 use is "as a root end filling material." This describes a material used within the body during a dental procedure, not a test performed outside the body on a sample to diagnose a condition.
- Device Description: The description details a powder that solidifies into a hard structure, consistent with a dental filling material. It doesn't describe reagents, instruments, or software used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
Therefore, based on the provided text, MTA MATERIAL is a medical device used in a dental procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MTA MATERIAL is indicated for use as a root end filling material.
MTA MATERIAL II is indicated for use as a root end filling material.
Product codes
KIF
Device Description
MTA MATERIAL is identical to K964174 and K980332. This submission is for a new intended use.
MTA MATERIAL is a powder consisting of fine hydrophilic particles. Hydration of the powder results in a colloidal gel, which solidifies to a hard structure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
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
JUL 31 1998
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343
P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
DATE PREPARED: MAY 8 ,1998
TRADE OR PROPRIETARY NAME: MTA MATERIAL
Root Filling Material COMMON OR USUAL NAME:
872.3820 Root canal filling resin material CLASSIFICATION NAME: K964174 PREDICATE DEVICE: Mineral Trioxide Aggregate K980332 MTA Material
DEVICE DESCRIPTION: MTA MATERIAL is identical to K964174 and K980332. This submission is for a new intended use.
MTA MATERIAL is a powder consisting of fine hydrophilic particles. Hydration of the powder results in a colloidal gel, which solidifies to a hard structure.
INTENDED USE: MTA MATERIAL is indicated for use as a root end filling material.
TECHNOLOGICAL CHARACTERISTICS: MTA MATERIAL is identical to DENTSPLY'S K964174 and K980332. This submission is for an additional intended use.
The fact that the formula is identical to K964174 and K980332 leads to the conclusion that biocompatibility studies with the formulation are not necessary
Therefore, we believe that the prior use of the formula in K964174 and K980332, the in-vitro and animal study performance data provided, and the results of previous testing in K964174 support the safety and effectiveness of MTA MATERIAL for the new intended use.
1
Substantial Equivalence Comparison:
ID of Predicate Device:
K964174 and K980332 are the predicate devices for this submission. MTA MATERIAL is identical to the predicates. This submission is for a new intended use only.
Statement of Similarities and/or Differences:
MTA MATERIAL is identical to K964174 and K980332. This submission is for a new intended use only.
- This submission addresses the new intended use: Root end filling material. ●
- K980332 addresses the uses: Repair of root canals as an apical plug during Apexification, . and repair of Root Perforations during root canal therapy (endodontic therapy) or as a consequence of internal resorption.
- K964174 addresses the use: Intended to be applied to a tooth to protect the pulp. ●
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure in black, with its wings forming a curved shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird. The text is in all capital letters and is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 | 1998
Mr. P. Jeffrey Lehn ·Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re : K981620 MTA Material II Trade Name: Requlatory Class: İI Product Code: KIF Dated: May 5, 1998 May 6, 1998 Received:
Dear Mr. Lehn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Lehn
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
: 中
Sincerely yours,
S. Dutrow for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(K) Number:
:
Device Name:
MTA MATERIAL II
MTA MATERIAL II is indicated for use as a root end filling material.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Skinner
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices 510(k) Number J K98 160
000007