(84 days)
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No
The summary describes a dental composite material and does not mention any AI or ML components or functionalities.
No
The device is a composite material used for dental restorations (building up teeth) and post cementations. While it aids in restoring tooth structure, it does not directly treat or prevent a disease and is not described as having an active therapeutic effect on the body beyond structural restoration.
No
The device is described as a material for "endodontic post cementations and core build-ups" and to "clinically build up human teeth (restauration in the case of mostly destroyed tooth structure)", which indicates it is a restorative or therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "self cure micro hybride composite" and a "material" used for "endodontic post cementations and core build-ups," indicating it is a physical dental 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 for "endodontic post cementations and core build-ups" and "clinically build up human teeth (restauration in the case of mostly destroyed tooth structure)". This describes a material used directly on the patient's body for structural restoration.
- Device Description: The description reinforces this by stating it's a "material for use by the dentist is to clinically build up human teeth".
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to test samples (like blood, urine, tissue) taken from the body to diagnose or monitor a condition. This device is a restorative material applied to the body.
N/A
Intended Use / Indications for Use
DC-Core / Core-Ide is a self cure micro hybride composite for endodontic post cementations and core build-ups (see enclosed Instruction for Use, MSDS).
Product codes
EBD
Device Description
The chemistry of DC-Core / Core-Ide P. L. Superior GmbH distributes for Roydent 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.
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
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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)
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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).
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§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
Roydent
FEB 4 1099
10. 510(k) Summary or Statement
SUMMARY
K984637
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 P. L. Superior GmbH to distribute the Roydent DC-Core / Core-Ide cited above manufactured at its facilities at Robert-Bosch-Str. 5, D-25335 Elmshorn, which can be used as Core Build Up material.
P. L. Superior GmbH spezializes in distributing and marketing numerous dental materials and related items manufactured at its facilities at Robert-Bosch-Str. 5, D-25335 Elmshorn, worldwide.
It is P. L. Superior GmbH`s intention to distribute DC-Core / Core-Ide cited herein which is manufactured at its facility located at Robert-Bosch-Straße 5, D-25335 Elmshorn, Germany, employing Good Manufacturing Practices (GMP's) pursuant and according to Title 21 CFR. P. L. Superior GmbH is certified to DIN EN ISO 9003 / DIN EN 46003 and Medical Device Directive (MDD) 93/42/EEC, annex VI.
The DC-Core / Core-Ide may be offered and marketed in the United States by Roydent, in which case P. L. Superior GmbH will maintain control and govern the production and primary packaging. Roydent will maintain the claims, labels, instructions and indications by himself which are consistent with this submission and final FDA 510(k) clearance to market by P. L. Superior GmbH.
The chemistry of DC-Core / Core-Ide P. L. Superior GmbH distributes for Roydent 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 / Core-Ide 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 1999
Mr. Don Leroy President ROYDENT Dental Products 1010 West Hamlin Road Rochester Hills, Michigan 48309
K984037 Re : Trade Name: Core-Ide Requlatory Class: II Product Code: EBD Dated: September 1, 1998 November 12, 1998 Received:
Dear Mr. Leroy:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Leroy
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 requlation 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.fda.gov/cdrh/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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9. Statement of Indications for Use
510(k) Number (if known): -
Device Name: DC-Core / Core-Ide
Indications for Use:
DC-Core / Core-Ide is a self cure micro hybride composite for endodontic post cementations and core build-ups (see enclosed Instruction for Use, MSDS).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Susan Rumper
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Over-The-Counter Use: