(84 days)
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No
The summary describes a dental composite material and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a composite material used for endodontic post cementations and core build-ups, which is a restorative dental material, not a therapeutic device.
No
Explanation: The device, DC-CORE, is described as a composite for endodontic post cementations and core build-ups. Its intended use is for restorative dental procedures, not for identifying the nature or cause of a disease or condition. It acts as a material for treatment rather than a tool for diagnosis.
No
The device is described as a "dual cured micro hybride composite," which is a physical material used in dentistry, 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 "endodontic post cementations and core build-ups" in human teeth. This is a direct application within the body (in vivo) for structural restoration.
- Device Description: It's described as a "dual cured micro hybride composite," which is a material used for dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, DC-CORE is a dental restorative material used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DC-CORE is a dual cured micro hybride composite for endodontic post cementations and core build-ups
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
DC-CORE is a dual cured micro hybride composite
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
Image /page/0/Picture/0 description: The image shows the text "FEB - 9 1999 S & C Polymer". The text is arranged in a way that the month and day are on the same line, followed by the year on the next line. The words "S & C Polymer" are located below the year. The text is in a simple, sans-serif font.
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 DC-Core cited above which can be used as Core Build Up 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 DC-Core 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 (MDD) 93/42/EEC, annex II.
DC-Core 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 and governed by Henry Schein Inc. or Pharmex.
The chemistry of DC-Core S & C Polymer GmbH manufactures for Henry Schein Inc. and Pharmex is commonly used in current dental materials.
The purpose of this material for use by the dentist is to clinically build up 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 DC-Core is substantially equivalent to "BIS-CORE Core Build Up Composite", a product manufactured and marketed by BISCO Dental Products, ITASCA, ILLINOIS USA.
Respectfully submitted
Jürgen Engelbrecht, Ph.D.
Regulatory Compliance Officer
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1999
Jürgen Ebgelbrecht, Ph.D. President S & C Polymer Silicon- und Composite-Spezialitäten GmbH Robert-Bosch-StraBe 5 D-25335 Elmshorn GERMANY
Re : K984097 Trade Name: DC-CORE Requlatory Class: II Product Code: EBF Dated: January 15, 1999 Received: January 25, 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 reqistration, 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. ਹੈ 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 requlation (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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Image /page/3/Picture/0 description: The image shows the text "K984097" in a large, bold font. Below this text, the words "Page" and "of" are printed, with blank lines indicating spaces for page numbers. The text is clear and easily readable, suggesting it is part of a document or label.
K984097 510(k) NUMBER (IF KNOWN):
DC-CORE DEVICE NAME:
INDICATIONS FOR USE:
ﺎ ﺑﮩﺖ ﻣ
DC-CORE is a dual cured micro hybride composite for endodontic post cementations and core build-ups (see enclosed page 6 of our actual 510(k) submission !).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﯾﺎ (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
Susan Varga
(Division Sign-Off) Division of Dents Infection Control, and General ting Delice 510(k) Number