(38 days)
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Not Found
No
The 510(k) summary describes a dental filling material and makes no mention of AI or ML technology.
No
The device is a composite for tooth fillings, which is used to restore the structure and function of a tooth rather than to treat or cure a disease or condition in a therapeutic sense.
No
Explanation: The device is described as a composite for tooth fillings, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "light cure microfill composite for tooth fillings," which is 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 "light cure microfill composite for tooth fillings." This describes a material used directly on the patient's teeth for restorative purposes.
- Device Description: The description reinforces its use as a "light cure microfill composite for tooth fillings."
- Anatomical Site: The anatomical site is "human teeth."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a dental restorative material.
N/A
Intended Use / Indications for Use
LC MICROFILL is a light cure microfill composite for tooth fillings (see enclosed Instruction for Use, MSDS).
Product codes
EBF
Device Description
It is the intention of S & C Polymer GmbH to manufacture the LC MICROFILL cited above which can be used as a tooth filling material.
The chemical composition and use of the LC MICROFILL material is the same as the material of RE-NAMEL of COSMEDENT, INC., 5419 N. Sheridan Road, Chicago, IL 60640, USA.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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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)
RE-NAMEL of COSMEDENT, INC.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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10. 510(k) Summary or Statement
SUMMARY
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 MICROFILL cited above which can be used as a tooth filling material.
S & C Polymer spezializes in manufacturing, distributing and marketing numerous dental materials and related items worldwide.
It is S & C Polymer GmbH's 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 (GMP's) 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.
LC MICROFILL may be offered and marketed in the United States by DISCUS Inc. and/or Pharmex, in which case S & C Polymer will maintain control and govern the production and primary packaging. The claims, labels, instructions and indications consistent with this submission and final FDA 510(k) clearance to market will be controlled by DISCUS Inc. or Pharmex.
The cited LC MICROFILL S & C Polymer GmbH manufactures for DISCUS Inc. and/or Pharmex is commonly used 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 the LC MICROFILL material is the same as the material of RE-NAMEL of COSMEDENT, INC., 5419 N. Sheridan Road, Chicago, IL 60640, USA. S & C Polymer GmbH`s intended use, performance, indications, proposed labels and instructions for use (see attached) are substantially similar to the above predicted device.
Respectfully submitted
Jürgen Engelbrecht, Ph. D.
Regulatory Compliance Officer
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a way that they also resemble a bird-like shape.
3 1999 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jurgen Enqelbrecht, Ph.D. President Regulatory Compliance Officer S & C Polymer GmbH Silicon- und Composite Spezialitaten GmbH Robert-Bosch-Str.5 D - 25335 ELMSHORN
Re: K991442 Trade Name: LC MICROFILL Regulatory Class: II Product Code: EBF Dated: March 1, 1999 Received: April 26, 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 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 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 regulations 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.
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Page 2 - Dr. Engelbrecht
this response to your premarket notification Please note: submission does not affect any 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 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" (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.fdalgov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Divishon of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
S & C Polymer
LC MICROFILL - Premarket Notification 510(k) Submission - page 6
9. Statement of Indications for Use
510(k) Number (if known):
Device Name:
LC MICROFILL
Indications for Use:
LC MICROFILL is a light cure microfill composite for tooth fillings (see enclosed Instruction for Use, MSDS).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Quare
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number __
Prescription Use: ✓
or
Over-The-Counter Use: