LC MICROHYBRID by S & C POLYMER GMBH

LC MICROHYBRID is a light cure micro hybride composite for tooth fillings. 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. 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.

AI/ML Overview

The provided text describes a 510(k) submission for a dental filling material called "LC MICROHYBRID." This document focuses on the regulatory submission process and the substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria typically associated with software or AI/ML medical devices.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI-specific details cannot be extracted from this document, as it pertains to a different type of medical device (dental filling material) and regulatory pathway.

Here's what can be inferred from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Cannot be inferred. The document does not specify quantitative acceptance criteria or detailed performance metrics. It focuses on the material's intended use and its substantial equivalence to a predicate device (ACORN), which implies that its performance is expected to be similar and acceptable for tooth fillings.

2. Sample Size Used for the Test Set and Data Provenance:

Cannot be inferred. As this is a material rather than a diagnostic or AI device, the concept of a "test set" for performance evaluation in the typical sense (e.g., image data for AI) is not applicable. There's no mention of specific clinical studies with defined sample sizes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Cannot be inferred. This concept is not relevant to the regulatory submission of a dental filling material. Ground truth establishes for AI models by experts.

4. Adjudication Method for the Test Set:

Cannot be inferred. Not applicable for a dental filling material's regulatory submission as described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Cannot be inferred. This type of study is specifically for evaluating diagnostic performance, often with human readers and AI assistance. It is not relevant to a dental filling material.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:

Cannot be inferred. This is relevant for AI algorithms. Not applicable here.

7. Type of Ground Truth Used:

Cannot be inferred. The document heavily relies on substantial equivalence to a predicate device (ACORN, K960565). The "truth" in this context is that the new device has "the same chemical composition and use" and "substantially similar intended use, performance, indications, proposed labels and instructions" as the already cleared predicate. This isn't "ground truth" in the AI sense but rather a regulatory comparison.

8. Sample Size for the Training Set:

Cannot be inferred. No training set is mentioned as this device is a material, not an AI model.

9. How the Ground Truth for the Training Set Was Established:

Cannot be inferred. No training set for AI.

Summary of what can be extracted directly relevant to the submission:

Device Name: LC MICROHYBRID
Predicate Device: ACORN (manufactured by S & C Polymer GmbH for Dent Zar International), 510(k) K960565
Basis of Acceptance: Substantial equivalence to the predicate device.
Key Equivalence Claims:
- Same chemical composition.
- Same use (tooth filling material).
- Substantially similar intended use, performance, indications, proposed labels, and instructions for use as the predicate device.
Intended Use: Clinically fill human teeth (restoration in the case of mostly destroyed tooth structure). Placed against an applied adhesive system.
Regulatory Class: II (as mentioned in the FDA letter, implying general and special controls may apply).
Product Code: EBF (Resin, Composite, Dental Restorative)

In conclusion, the provided text is a 510(k) summary for a dental restorative material, not an AI/ML device. Therefore, the specific details requested regarding acceptance criteria and studies typical for AI software are not present and cannot be extracted. The acceptance criteria for this device revolve around demonstrating substantial equivalence to a legally marketed predicate device in terms of composition, intended use, and performance, rather than specific quantitative performance metrics tested in the context of an AI algorithm.

Summary

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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

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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

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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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1/6/99

(PLEASE DO NOT MRITE BELOW THIS LANS-CONTINUE ON ANOTHER PAGE IF NEEDED.) .

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

Regulation Number and Section

§ 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.