(35 days)
Not Found
No
The summary describes a dental composite material, which is a passive substance and does not involve any computational or algorithmic processes like AI/ML.
Yes
The device, LC MICROHYBRID, is a composite for tooth fillings used by a dentist to clinically fill human teeth (restoration). This falls under the definition of a therapeutic device as it is intended to treat a condition (destroyed tooth structure) by restoring the tooth.
No
Explanation: The device, LC MICROHYBRID, is described as a light cure micro hybride composite for tooth fillings, specifically for "clinically fill human teeth (restauration in the case of mostly destroyed tooth structure)." This indicates it is a restorative material used for treatment, not for diagnosing a condition or disease.
No
The device is a light cure micro hybride composite material, which is a physical substance used for tooth fillings, 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" and "to clinically fill human teeth (restauration in the case of mostly destroyed tooth structure)". This is a direct therapeutic intervention on the patient's body.
- Device Description: The description reinforces its use as a material placed directly into the tooth for restoration.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens for diagnostic purposes.
Therefore, LC MICROHYBRID is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
LC MICROHYBRID is a light cure micro hybride composite for tooth fillings.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth
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.
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
JAN 20 1999
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 MICROHYBRID cited above which can be used as 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 MICROHYBRID 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. The claims, labels, instructions and indications consistent with this submission and final FDA 510(k) clearance to market will be controlled by Henry Schein Inc. or Pharmex.
The cited LC MICROHYBRID S & C Polymer GmbH manufactures for Henry Schein Inc. 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 LC MICROHYBRID material is the same as "ACORN", a product manufactured by S & C Polymer GmbH for Dent Zar International, 19643 Trull Brook Dr., Tarzana, CA 91356, USA, 510(k) K960565. S & C Polymer GmbH's intended use, performance, indications, proposed labels and instructions for use (see attached) are substantially similar to the predicted device see 510(k) K960565).
Respectfully submitted
Jürgen Engelbrecht, Ph. D.
Regulatory Compliance Officer
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird's head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1999
Jürgen Ebgelbrecht, Ph.D. President S & C Polymer Silicon- und Composite-Spezialitäten GmbH Robert-Bosch-StraBe 5 D-25335 Elmshorn GERMANY
Re : K984484 LC Microhybrid Trade Name: Regulatory Class: II Product Code: EBF Dated: October 1, 1998 Received: December 16, 1998
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 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 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 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" (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
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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of Page
| 510(k) NUMBER (IF KNOWN): | K984484 |
|---|---|
| DEVICE NAME: | LC MICROHYBRID |
| INDICATIONS FOR USE: | LC MICROHYBRID is a light cure micro hybride composite for tooth fillings. |
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Device Evaluation (ODE) Concurrence of CDRH, Office of
Prescription Use Prescripcion (Per 21 CFR 801.109)
OR Over-The-Counter-Use
(Optional Format 1-2
Seundra L. Shirdond for MSR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ... 4 84484