(46 days)
Flowable composite restorative material for: Minimally-invasive fillings Restorations of type III and V cavities (according to Black) Liner for restorations of type I and II cavities Small restorations of type I and II cavities Deciduous tooth fillings Fissure sealing Extended fissure sealing Tunnel preparation Repair of composite fillings and ceramic veneers Filling of defects and undercuts in crowns, inlays, and onlays Cementing porcelain veneers, crowns, inlays, and onlays Refacing acrylic temporaries Blockouts
PROMPTFLOW® is classified as tooth shade resin material (21 C.F.R. § 872.3660) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth. PROMPTFLOW® is a flowable composite restorative material.
The provided text is a 510(k) summary for the dental device PROMPTFLOW®, a flowable composite restorative material. It largely focuses on establishing substantial equivalence to predicate devices (REFERENCE® and DYRACT® FLOW) based on chemical composition, physical/mechanical properties, and intended use.
Crucially, the document does NOT contain information about specific acceptance criteria (numerical thresholds for performance) or an explicit study describing how PROMPTFLOW® met these criteria.
It is a regulatory submission for a device modification (Special 510(k)) where the manufacturer asserts that due to its fundamental similarity and comparative performance to existing devices, it is safe and effective for its stated indications for use. The approach is to compare the modified device (PROMPTFLOW®) to the unmodified predicate (REFERENCE®) and another similar flowable material (DYRACT® FLOW) to demonstrate suitability.
Therefore, many of the requested sections regarding specific study details cannot be filled from the provided text.
Here's an attempt to answer based on the available information, noting where data is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating that PROMPTFLOW® has "the same fundamental scientific technology and the same intended use as REFERENCE®" and that its properties, while slightly reduced in some mechanical characteristics due to flowability, are comparable to another predicate flowable material, DYRACT® FLOW.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Intended Use | PROMPTFLOW® has in general the same intended use as REFERENCE®. |
| Operating Principle | PROMPTFLOW® is used by the same operating principle as REFERENCE®. |
| Basic Chemical Design | PROMPTFLOW® incorporates the same basic chemical design as REFERENCE®. Reduced filler content was made to achieve flowability. |
| Shelf Life | PROMPTFLOW® has the same shelf life as REFERENCE®. |
| Manufacturing | PROMPTFLOW® is manufactured using the same materials and processes as REFERENCE®. |
| Physical and Mechanical Properties | Due to reduced filler content to achieve flowability, some mechanical strength characteristics decreased compared to REFERENCE®. However, "comparison with another flowable restorative material, DYRACT® FLOW by Dentsply, shows, that PROMPTFLOW® is a suitable material for the claimed indications for use." (Specific quantitative comparisons are not provided in this summary). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document describes a comparison between the modified and unmodified devices and a predicate flowable device, but does not detail the specific test sample sizes, study design (retrospective/prospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Ground truth establishment by experts is not described in this regulatory submission for a dental material.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are not applicable nor described for this type of submission for a dental composite material.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is not mentioned as this device is a dental material and not an AI-powered diagnostic system. Therefore, AI assistance and effect size on human readers are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable, as PROMPTFLOW® is a dental restorative material, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a dental restorative material, "ground truth" would typically refer to established standards for material properties (e.g., ISO standards for dental materials), chemical composition, and performance in standardized physical and mechanical tests. While the document mentions "physical and mechanical properties," it does not detail the specific "ground truth" methodology beyond implying comparison to predicate devices and established suitability for indications. There's no mention of expert consensus, pathology, or outcomes data in the context of establishing "ground truth" for the material's properties in this summary.
8. The sample size for the training set
This information is not provided. As this is not an AI/ML device, a "training set" in that context is not relevant. If referring to material development, information on the sample sizes used in R&D for formulation and initial testing is not present in this 510(k) summary.
9. How the ground truth for the training set was established
This information is not provided, and the concept of a "training set" with established ground truth, as typically understood for AI/ML devices, is not applicable here.
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DEG - 6 1999
Image /page/0/Picture/1 description: The image shows a sequence of digits and a letter, all in bold black font. The sequence starts with the letter 'K', followed by the numbers '9', '3', '5', and '6'. The numbers are written in a simple, rounded style, and the letter 'K' is also in a similar style. The image is simple and clear, with the focus on the sequence of characters.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV.
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, Manager U.S.Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| Andreas_Petermann@ESPE.de | |
| Date: | October 19, 1999 |
| Name of Device | |
| Proprietary Name: | PROMPTFLOW® |
| Classification Name: | Tooth shade resin material |
| Common Name: | Composite restorative material |
| Predicate Device | |
| REFERENCE® by ESPE | K 992966 |
| DYRACT® FLOW by Dentsply | K 982395 |
Description for the Premarket Notification
PROMPTFLOW® is classified as tooth shade resin material (21 C.F.R. § 872.3660) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth.
Image /page/0/Picture/7 description: The image shows the logo for ESPE Special 510(k) PROMPTFLOW®. The text "Special 510(k) PROMPTFLOW®" is at the top of the image. Below the text is the ESPE logo, which features a stylized tree inside of a square to the left of the word ESPE.
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The recently 510(k) cleared composite restorative material REFERENCE® will be marketed under the tradename PROMPTFIL®. However, in this Special 510(k) submission the name REFERENCE® is used to avoid misunderstanding and confusion.
ESPE is submitting this Special 510(k) for modifications of its composite based restorative material REFERENCE®. The modification results in PROMPTFLOW®, a flowable composite restorative material. PROMPTFLOW® has the same fundamental scientific technology and the same intended use as REFERENCE®, therefore, we believe these modifications are eligible for the Special 510(k) process.
To achieve the flowability of PROMPTFLOW® the filler content had to be reduced. As a result, some mechanical strength characteristics decreased which leads to a reduced range of indications. However, comparison with another flowable restorative material, DYRACT® FLOW by Dentsply, shows, that PROMPTFLOW® is a suitable material for the claimed indications for use.
In this Special 510(k) Device Modification submission the chemical composition, the physical and mechanical properties, and the indications for use of both the unmodified REFERENCE® and the modified PROMPTFLOW® are compared. Furthermore, ESPE's design control activities are shortly described. DYRACT® FLOW is provided to have a predicate flowable restorative material because, as described above, the physical and mechanical properties of PROMPTFLOW® are not as strong as those of REFERENCE® due to the lower filler content.
However, the modified restorative material PROMPTFLOW® has the following similarities to the unmodified REFERENCE®:
- PROMPTFLOW® has in general the same intended use .
- PROMPTFLOW® is used by the same operating principle .
- . PROMPTFLOW® incorporates the same basic chemical design
- PROMPTFLOW® has the same shelf life .
- PROMPTFLOW® is manufactured using the same materials and processes .
In summary PROMPTFLOW® described in this submission is, in our opinion, substantially equivalent to the predicate devices.
Image /page/1/Picture/11 description: The image shows the words "Special 510(k) PROMPTFLOW®" in black font. Below this text is the word "ESPE" in a larger black font. To the left of the word ESPE is a logo of a tree.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human figures or abstract shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 1990
Mr. Andreas Petermann Manager U.S. Regulatory Affairs ESPE Dental AG ESPE Platz D2229 Seefeld,Bavaria
Re: K993566 Promptflow® Trade Name: Regulatory Class: II Product Code: EBF Dated: October 28, 1999 Received: November 1, 1999
Dear Mr. 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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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
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Page 2 - Mr. Petermann
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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" (21 CFR 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.fday.gov/cdrh/dsmamain.html".
Sincerely yours,
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
(As Required by 21 C.F.R. § 801.109)
510(k) Number:
Device Name:
Promptflow®
Indications for use:
Flowable composite restorative material for:
Minimally-invasive fillings
Restorations of type III and V cavities (according to Black)
Liner for restorations of type I and II cavities
Small restorations of type I and II cavities
Deciduous tooth fillings
Fissure sealing
Extended fissure sealing
Tunnel preparation
Repair of composite fillings and ceramic veneers
Filling of defects and undercuts in crowns, inlays, and onlays
Cementing porcelain veneers, crowns, inlays, and onlays
Refacing acrylic temporaries
Blockouts
Prescription use: 12
Over-the counter use □
(Division Sign-Off Division of Dental, Infection C and General Hospital 510(k) Numbe
§ 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.