(42 days)
Not Found
No
The summary describes a chemical bonding agent and its components, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is a bonding agent for restorative dental materials, which is not considered a therapeutic device. Its purpose is to improve the retention of fillings, not to treat a disease or condition.
No
The device is a bonding agent used to improve the retention of restorative materials in a tooth, not to diagnose a condition.
No
The device description clearly states it is a "Resin Tooth Bonding Agent" and describes its physical composition and intended application as a material painted on a tooth. This indicates a physical, material-based device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Bonding of Enamel/Dentin and Compomer Restorative Materials." This describes a procedure performed directly on a patient's tooth to improve the retention of dental materials.
- Device Description: The device is described as a "Resin Tooth Bonding Agent" intended to be "painted on the interior of a prepared cavity of a tooth." This is a direct application to the patient's anatomy.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not involve testing samples from the body.
The information provided clearly indicates this is a dental device used for direct application within the mouth, not for testing biological samples.
N/A
Intended Use / Indications for Use
Bonding of Enamel/Dentin and Compomer Restorative Materials
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
РкомРт® L-Pop® is classified as a Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer restorative material).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth
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.
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
§ 872.3200 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.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ll.
Submitter
| Name: | ESPE Dental AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Contact: | Dr. Andreas Petermann, Regulatory Affairs |
| Phone: | 011-49-8152-700395 |
| Fax: | 011-49-8152-700869 |
| Andreas_Petermann@ESPE.de | |
| Date: | 11/17/1998 |
Name of Device
| Proprietary Name: | PROMPT® L-POP® |
|---|---|
| Classification Name: | Resin Tooth Bonding Agent |
| Common Name: | Compomer Bonding Agent |
Predicate Devices
| HYTAC® OSB by ESPE..................................(K962442) |
|---|
| HYDROGUM® by Zhermack.....................(K935898) |
| COMPOLUTE® by ESPE........................(K974458) |
Description for the Premarket Notification
РкомРт® L-Pop® is classified as a Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer restorative material).
PROMP® L-POP® is similar and substantially equivalent in intended use, composition, and function to ESPE'S compomer bonding material HYTAC® OSB. The filler of PROMPT® L-POP® is contained in Zhermack's alginate based impression material HYDROGUM®. ESPE's composite luting cement COMPOLUTE®
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contains the same photo initiator. All above mentioned predicate devices are well established and determined to be safe and effective.
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510(k) PROMPT® L-POP®
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 8 1999
Dr. Andreas Petermann Requlatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany
Re : K984246 Prompt® L-Pop® Trade Name: Regulatory Class: II Product Code: KLE Dated: November 17, 1998 November 27, 1998 Received:
Dear Dr. Petermann:
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 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). 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 (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. ਰੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Dr. Petermann
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (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" (21CFR 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/dsma/dsmamajp.html." .
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
Device Name:
PROMPT® L-POP®
Indications for use:
. Bonding of Enamel/Dentin and Compomer Restorative Materials
Susan Ruaser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription use: 因
Over-the counter use □