(54 days)
Not Found
Not Found
No
The provided text describes a dental sealant/filling material and its intended uses. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The description focuses on the material's application and function.
No.
The intended uses listed (sealing, filling, restoration, anchorage) describe preventive and restorative dental procedures rather than treating a disease or condition in a therapeutic manner.
No
The device's intended uses, such as sealing pits, fissures, and cavities, sealing damaged enamel, anchoring orthodontic appliances, and restoring small defects, are all therapeutic or restorative actions, not diagnostic ones. Diagnostic devices are used to identify or detect a disease or condition.
No
The provided 510(k) summary describes a device with intended uses related to dental procedures (sealing, filling, restoration). These applications typically involve physical materials and instruments applied to teeth, which are hardware components. The summary lacks a device description, making it impossible to confirm if it's software-only, but the intended uses strongly suggest a hardware component is involved.
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 direct application and manipulation of materials on teeth for sealing, filling, and restoration. These are clinical procedures performed on the patient's body, not tests performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly points to a material or device used in dental procedures.
- No Mention of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's intended use does not align with this definition.
N/A
Intended Use / Indications for Use
- Sealing/filling of pits and fissures as well as small cavities
- Sealing/facing of damaged enamel surfaces
- Anchorage of orthodontic appliances
- Sealing of composites or cement fillings
- Restoration of small defects in composites and amalgam fillings
- Sealing of deciduous teeth
Product codes
EBC
Device Description
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, along with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2002
VOCO GmbH C/O Mr. Gerald W. Shipps Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K021842
Trade/Device Name: Admira Seal Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: May 28, 2002 Received: June 05, 2002
Dear Mr. Shipps:
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 such additional controls. Existing major regulations affecting vour 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.
1
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number: K021842
Device Name: Admira Seal
Indications for Use:
- Sealing/filling of pits and fissures as well as small cavities ●
- Sealing/facing of damaged enamel surfaces ●
- Anchorage of orthodontic appliances .
- Sealing of composites or cement fillings .
- Restoration of small defects in composites and amalgam fillings ●
- Sealing of deciduous teeth .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PACE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻤﺎ ﻳﻮﻧﻴﻮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ Prescription Use
OR
Over-The-Counter Use
Rohit Shelat DDS for Dr. Susan Kummer
ction Control,