(153 days)
Not Found
No
The summary describes a dental composite material and its physical properties, with no mention of AI or ML.
No
The device is a direct filling material for restoring cavities, functioning as a dental composite, not a therapeutic device.
No
Explanation: The device description states Meridian is a "direct filling material for restoration" and a "light curing universal dental composite material". Its intended use is for "restoration of Class I to V cavities and for restoration of deciduous teeth". This indicates it is a therapeutic or restorative device, not one used for diagnosis.
No
The device description clearly states it is a "light curing universal dental composite material," which is a physical substance, not software. The performance studies also focus on material properties like strength and solubility, further indicating it is a hardware/material device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth." This describes a material used directly on the patient's teeth for treatment, not for testing samples taken from the body to diagnose a condition.
- Device Description: The description states it's a "light curing universal dental composite material." This is a material used in dental procedures, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The information provided clearly indicates this is a dental restorative material used in a clinical setting for treatment, not a diagnostic device used in a laboratory or point-of-care setting to analyze samples.
N/A
Intended Use / Indications for Use
Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.
Product codes
EBF
Device Description
Meridian is a light curing universal dental composite material of the latest nanohybrid type having an optimized chemical composition.
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
The device was tested in accordance with ISO 4049:2009 for Polymer based dental restorative materials for Water Absorption, Water solubility, Radiopacity, Flexural Strength, Depth of Cure. Modulus of Elasticity, and Compressive Strength and the results from testing demonstrates that Meridian is substantially equivalent to the predicate device. Biocompatibility testing and evaluation was also carried out according to ISO 10993.
Key Metrics
Not Found
Predicate Device(s)
Tetric EvoCeram (K042819)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(K) SUMMA
Meridian
| Contact: | Donna Marie Hartnett |
|---|---|
| Company: | Ardent, Inc. 175 Pineview Drive, Amherst, NY 14228 |
| (716) 691-0010 | |
| Date Prepared: | June 13, 2013 |
| Proprietary Name: | Meridian |
| Classification Name: | Material, Tooth Shade, Resin (872.3690) |
| Predicate Devices: | Tetric EvoCeram (K042819) |
Meridian is a light curing universal dental composite material of the Device Description: latest nanohybrid type having an optimized chemical composition.
The predicate device to which Meridian has been compared is Tetric EvoCeram (K042819). For this application. Tetric EvoCeram has been compared to its predicate with regard to chemical composition, performance data and indications for use. The comparison shows that Meridian is substantially equivalent to the predicate device.
Intended Use: Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.
Technological Characteristics: The device design, i.e. delivery form, and intended use of Meridian and the predicate device are the same. The composition of the subject device has been modified from the predicate, however, there are no ingredients in the subject device which pose any new issues of safety and effectiveness.
Guidance Document: The submission was prepared in accordance with FDA Guidance document entitled Dental Composite Resin Devices - Premarket Notification (510K) Submissions dated October 26, 2005.
Testing Summary: The device was tested in accordance with ISO 4049:2009 for Polymer based dental restorative materials for Water Absorption, Water solubility, Radiopacity, Flexural Strength, Depth of Cure. Modulus of Elasticity, and Compressive Strength and the results from testing demonstrates that Meridian is substantially equivalent to the predicate device. Biocompatibility testing and evaluation was also carried out according to ISO 10993.
Conclusion: Meridian is substantially equivalent to the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2013
AB Ardent C/O Ms. Donna Marie Hartnett Director Quality Assurance/Regulatory Affairs 175 Pineview Drive AMHERST NY 14228
Re: K131753
Trade/Device Name: MERIDIAN Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 3, 2013 Received: September 5, 2013
Dear Ms Hartnett:
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.
2
Page 2 - Ms. Hartnett
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 (800) 638-2041 or (301) 796-7100 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/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.
Mary S. Runner -S
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
3
Indications for Use
510(k) Number (if known): K134753
Device Name: MERIDIAN
Indications For Use:
Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (21 CFR 807 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 1
Andrew I. Steen -S 2013.11.14 08:21:40 -05'00'