(55 days)
Not Found
Not Found
No
The summary describes a dental composite material and does not mention any AI or ML capabilities.
No
The device is a dental composite used for fillings, sealings, and cementing, which are restorative procedures, not therapeutic. Its predicate device ("FLOW IT") is also a restorative dental material.
No
Explanation: The device is described as a "flowable light current micro hybrid composite for tooth fillings, sealings and cementing," which indicates it is a restorative material used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "flowable light current micro hybride composite," which is a physical material used for dental procedures, 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 "tooth fillings, sealings and cementing." This is a direct application to the human body (teeth) for restorative purposes.
- Device Description: The description refers to it as a "flowable light current micro hybride composite material." This is a material used in dental procedures.
- Anatomical Site: The anatomical site is "human teeth."
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVDs are devices used in vitro (outside the body) to examine specimens derived from the human body. This device is used in vivo (within the body) for a therapeutic/restorative purpose.
N/A
Intended Use / Indications for Use
LC FLOWFILL is a flowable light current micro hybride composite for tooth r fillings, sealings and cementing.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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 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
10. 510(k) Summary or Statement
SUMMARY
Kaa0 108
Gentleman:
This submission is pursuent to paragraph 510(k) of the Federal Drug and Cosmetic Act of May, 1976 (as amended) (Title 21 USC). All informations contained herein are to be considered and treated as CONFIDENTIAL COMMERCIAL INFORMATION.
It is the intention of S & C Polymer GmbH to manufacture the LC FLOWFILL cited above which can be used as LC FLOWFILL material.
S & C Polymer spezializes in manufacturing, distributing and marketing numerous dental materials and related items worldwide.
It is S & C Polymer GmbHs intention to manufacture the cited product herein at its facility located at Robert-Bosch-Straße 5, D-25335 Elmshorn (formerly Offenauer Weg 19, D-25335 Bokholt-Hanredder), Germany, employing Good Manufacturing Practices (GMPs) pursuant and according to Title 21 CFR. S & C Polymer GmbH is certified to DIN EN ISO 9001 / DIN EN 46001 and Medical Device Directive 93/42/EEC, annex II.
The above cited product may be offered and marketed in the United States by Henry Schein Inc. and/or Pharmex, in which case S & C Polymer will maintain control and govern the production and primary packaging. Henry Schein Inc. and/or Pharmex will maintain the claims, labels, instructions and indications by themselves which are consistent with this submission and final FDA 510(k) clearance to market by Henry Schein Inc. and/or Pharmex.
The cited LC FLOWFILL material S & C Polymer GmbH manufactures for Henry Schein Inc. and/or Pharmex is commonly found in current dental materials.
The purpose of this material for use by the dentist is to clinically fill human teeth (restauration in the case of mostly destroyed tooth structure). The material is in general placed against an applied adhesive system.
The chemical composition and use of LC FLOWFILL material is substantially equivalent to "FLOW IT", a product manufactured and marketed by Pentron USA. S & C Polymer GmbH s and Henry Schein Inc. and/or Pharmex`s intented use, performance, indications, proposed labels and instructions for use (see attached) are substantially similar to the predicted device (see attached).
Respectfully submitted
Jürgen Engelbrecht, Ph. D.
Regulatory Compliance Officer
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1999
Jürgen Ebgelbrecht, Ph.D. President S & C Polymer Silicon- und Composite-Spezialitäten GmbH Robert-Bosch-StraBe 5 D-25335 Elmshorn GERMANY
Re : K990108 LC FLOWFILL Trade Name: Requlatory Class: II Product Code: EBF February 23, 1999 Dated: Received: March 1, 1999
Dear Dr. Engelbrecht:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ 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
2
Page 2 – Dr. Engelbrecht
through 542 of the Act for devices under the Electronic Chrough 342 or the not al 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 debering of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed production wour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
v A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| K990108 |
|---|
510 (k) NUMBER (IF KNOWN):
IC FLOWFILL DEVICE NAME:
. :
INDICATIONS FOR USE: LC FLOWFILL is a flowable light current micro hybride composite for tooth r fillings, sealings and cementing.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AND THER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. .
Prescription Use
(Per 21 CFR 801.109) OR Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K990108
้ ( (