(46 days)
K 992966, K 982395
Not Found
No
The document describes a flowable composite restorative material and does not mention any AI or ML capabilities.
No
The device is a restorative material for teeth, primarily used to fill and repair cavities and defects. It does not actively treat or prevent a disease, but rather restores an anatomical structure.
No
The device is a restorative material used for filling cavities and repairing teeth, which is a treatment function, not a diagnostic one.
No
The device is a physical material (flowable composite restorative material) and not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes the device as a "flowable composite restorative material" used for restoring teeth. This is a direct treatment applied to the body, not a test performed on a specimen outside the body.
- Anatomical Site: The anatomical site is "Teeth," which are part of the human body, not a specimen taken from the body.
- 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, or being used in a laboratory setting.
The device is a dental restorative material, which falls under a different category of medical devices.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
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.
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®.
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, 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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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.
K 992966, K 982395
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
§ 872.3690 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.
0
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
4
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