(88 days)
Not Found
Not Found
No
The summary describes a material used for sealing and protecting dental surfaces, with no mention of software, data processing, or AI/ML terms.
No.
The device's intended use is for protection, sealing, and smoothing of glass ionomer cement surfaces, which are functions related to dental material application rather than treating a disease or condition in a patient.
No
The document describes the device's function as protection, sealing, and smoothing surfaces, not identifying or analyzing medical conditions.
No
The provided text describes a material (glass ionomer cement protection/sealing) and its intended use, not a software device. There is no mention of software, algorithms, data processing, or any other characteristics of a software medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in protecting, sealing, and smoothing dental materials (glass ionomer cement) applied to a patient's teeth. This is a direct application to the body or a material applied to the body, not a test performed in vitro (outside the living body) on samples like blood, urine, or tissue.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
Therefore, this device falls under the category of a dental material or restorative product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Protection of glass ionomer cement surfaces against both humidity and drying immediately after placing the filling
Sealing and smoothing of glass ionomer cement surfaces after polishing
Sealing of cervical margin of cementations immediately after removal of excess
Product codes
KLE
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): 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.
Not Found
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
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2003
Voco GmbH C/O Gerald Shipps Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K030844
Trade/Device Name: Final Varnish LC Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 14, 2003 Received: March 17, 2003
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 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.
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 (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.
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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runoer
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
i10(k) Number: _ 长0 30844
Device Name: Final Varnish LC_________________________________________________________________________________________________________________________________________________
Indications for Use:
Protection of glass ionomer cement surfaces against both humidity and drying immediately after placing the filling
Sealing and smoothing of glass ionomer cement surfaces after polishing
Sealing of cervical margin of cementations immediately after removal of excess
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| OR | |
| Over-The-Counter Use |
Ken Muly for MsR
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
| 510(k) Number: | K030844 |
|---|---|
| ---------------- | --------- |
-୍ଦ