(60 days)
K 984246
Not Found
No
The summary describes a chemical bonding agent and does not mention any computational or data-driven components indicative of AI/ML.
No
The device is a bonding agent used to improve the retention of restorative materials in dental cavities, which is not considered a therapeutic function.
No
This device is described as a "Resin Tooth Bonding Agent" intended to improve the retention of restorative materials (compomer and composite) in a tooth cavity. Its purpose is to bond materials, not to diagnose a condition or disease.
No
The device description clearly states it is a "Resin Tooth Bonding Agent" intended to be "painted on the interior of a prepared cavity of a tooth," which describes 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 for bonding dental materials to tooth structure (dentin/enamel). This is a direct application within the body (or on a part of the body), not for examining specimens in vitro (outside the body).
- Device Description: It's classified as a "Resin Tooth Bonding Agent" and is applied to the interior of a prepared tooth cavity. This further reinforces its use within the oral cavity.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for bonding restorative materials to tooth structure.
N/A
Intended Use / Indications for Use
Bonding between dentin/enamel and composite filling materials.
Bonding between dentin/enamel and compomer filling materials.
Bonding mediator for fissure sealing
Bonding mediator for bracket attachment
Product codes
KLE
Device Description
PROMPT® 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 and composite restorative material).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth / dentin/enamel
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)
The effectiveness of PROMPT® L-POP® is established by performance data.
The results of safety and effectiveness analysis show that the range of indications of the device can be expanded and that PROMPT® L-POP® is a safe and effective dental adhesive.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 984246
Reference Device(s)
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
ll.
Image /page/0/Picture/1 description: The image shows a sequence of digits and a letter, seemingly written with a thick brush. The sequence reads 'K92048'. The characters are bold and have a somewhat rough, hand-drawn appearance, suggesting they may have been created using a brush or marker with a broad tip.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
| Name: | ESPE Dental AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas Petermann, Regulatory Affairs |
| Phone: | 011-49-8152-7001395 |
| Fax: | 011-49-8152-7001869 |
| E-mail: | Andreas_Petermann@ESPE.de |
| Date: | June 15, 1999 |
Name of Device
| Proprietary Name: | PROMPT® L-POP® |
|---|---|
| Classification Name: | Resin Tooth Bonding Agent |
| Common Name: | Dental Adhesive |
Predicate Device
PROMPT® L-POP® by ESPE ....................................................................................................................................................... (old formula)
Description for the Premarket Notification
РяомРт L-POP® is classified as a Resin Tooth Bonding Agent (21 С.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 and composite restorative material).
On January 8, 1999 a device called РяомРт® L-РоР® was 510(k) cleared by the FDA (K 984246). The intended use of РяомРт® L-РоР® (old formula) was limited to the bonding of compomer restorative materials. By little variations of the product
Image /page/0/Picture/12 description: The image shows the logo for ESPE. The logo includes the text "510(k) PROMPT® L-POP®" above the ESPE logo. The ESPE logo includes a tree-like symbol to the left of the word "ESPE". The logo is in black and white.
1
composition it is now possible to expand the range of indications on bonding of composite restorative materials as well.
Due to the FDA guidance document: "Deciding When to Submit a 510(k) for a Change to an Existing Device" published by the Office of Device Evaluation on January 10, 1997 a new 510(k) has to be submitted because labeling changes of PROMPT® L-POP® affect the indications for use.
However, PROMPT® L-POP® (new formula) is similar and substantially equivalent to РяомРт L-P0P (old formula). To provide evidence for the safety of the device, the material safety data sheets of the components and a toxicological assessment carried out by an independent institute are attached. The effectiveness of РяомРт L-POP® is established by performance data.
The results of safety and effectiveness analysis show that the range of indications of the device can be expanded and that РяомРт L-РоР° is a safe and effective dental adhesive.
Image /page/1/Picture/4 description: The image contains the text "510(k) PROMPT L-POP" in a sans-serif font. Below the text is a logo that includes a stylized tree-like symbol to the left of the word "ESPE" in a bold, sans-serif font. The logo appears to be a company or product identifier, possibly related to medical devices or healthcare, given the "510(k)" reference, which is associated with FDA clearances for medical devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 16 1999
Dr. Andreas Petermann Requlatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany
Re : K992048 Modification of Prompt L-Pop Trade Name: Regulatory Class: II Product Code: KLE Dated: June 15, 1999 June 17, 1999 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. ਸ 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 requlation (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 requlation may result in requlatory 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
3
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 yitro 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 requlation 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/dsmamain.html".
Sincerely yours,
Patricio Cucurella
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
STATEMENT OF INDICATIONS FOR USE
Device Name:
PROMPT® L-POP®
Indications for use:
Bonding between dentin/enamel and composite filling materials.
Bonding between dentin/enamel and compomer filling materials.
Bonding mediator for fissure sealing
Bonding mediator for bracket attachment
Susan Runnos
ental, Infection Control, Seneral Hosn 510(k) Number
Prescription use: 因
Over-the counter use □