(17 days)
KETAC®-MOLAR
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No
The document describes a dental cement with a modified setting time and does not mention any AI or ML components.
No
The device is a dental glass ionomer cement used for fillings and core build-ups, which are restorative procedures, not therapeutic ones aimed at treating a disease or health problem.
No
Explanation: The device is described as a dental glass ionomer cement used for fillings and core build-ups, which are restorative functions, not diagnostic ones.
No
The device description clearly states it is a dental glass ionomer cement, which is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed directly on a patient's teeth (fillings, core build-ups, linings). IVDs are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The description clearly states it is a "dental glass ionomer cement" used as a "temporary tooth filling." This is a material used in a clinical setting for treatment, not for diagnostic testing of specimens.
- Classification: The device is classified under 21 C.F.R. § 872.3275(b) as a class II device. This regulation pertains to "Resin tooth restorative material," which is a category for dental materials used for restoring teeth, not for in vitro diagnostics.
The information provided strongly indicates this is a dental restorative material used for direct patient care, not an IVD.
N/A
Intended Use / Indications for Use
Linings for class I and II cavities filled with composite
Core build-ups
Fillings in deciduous teeth
Fillings in class I cavities located in non-occlusal load bearing areas
Fillings in class V cavities if the esthetics are not of primary importance
Temporary fillings in class I and II cavities
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
KETAC®-MOLAR QUICK is a dental glass ionomer cement (other than zinc oxideeugenol) to serve e.g. as a temporary tooth filling and is classified according to 21 C.F.R. § 872.3275(b) as a class II device.
ESPE is submitting this Special 510(k) for modifications to its glass ionomer restorative cement KETAC®-MOLAR. The modified material is characterized by a shorter setting time. The material will be marketed under the name KETAC®-MOLAR Quick.
Like KETAC®-MOLAR, KETAC®-MOLAR QUICK is available in capsules tradenamed APLICAP®.
The modified glass ionomer cement KETAC®-MOLAR Quick has the following similarities to the unmodified KETAC®-MOLAR:
- KETAC®-MOLAR QUICK has the same intended use ●
- KETAC®-MOLAR QUICK is used by the same operating principle .
- KETAC®-MOLAR QUICK incorporates the same basic chemical design .
- . KETAC®-MOLAR QUICK has the same shelf life
- . KETAC®-MOLAR QUICK is manufactured and packaged using the same materials and processes
All chemical components of KETAC®-MOLAR QUICK are already part of the predicate device KETAC -MOLAR, are contained in other 510(k) cleared devices manufactured by ESPE, or are described in a pharmacopoeia. Therefore, we believe that additional biocompatibility testing is not required.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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.
KETAC®-MOLAR
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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§ 872.3690 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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IV. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
| Company: | ESPE Dental AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas Petermann, Manager U.S. |
| Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| Andreas_Petermann@ESPE.de | |
| Date: | December 15 1999 |
Name of Device
| Proprietary Name: | KETAC -MOLAR QUICK |
|---|---|
| ------------------- | --------------------- |
Classification Name: .........................................................................................................................................................
Common Name: .................................................................................................................................................................
Predicate Device
KETAC®-MOLAR .................................................................................................................................................................
Description for the Premarket Notification
KETAC®-MOLAR QUICK is a dental glass ionomer cement (other than zinc oxideeugenol) to serve e.g. as a temporary tooth filling and is classified according to 21 C.F.R. § 872.3275(b) as a class II device.
ESPE is submitting this Special 510(k) for modifications to its glass ionomer restorative cement KETAC®-MOLAR. The modified material is characterized by a
1
shorter setting time. The material will be marketed under the name KETAC®-MOLAR Quick.
Like KETAC®-MOLAR, KETAC®-MOLAR QUICK is available in capsules tradenamed APLICAP®.
The modified glass ionomer cement KETAC®-MOLAR Quick has the following similarities to the unmodified KETAC®-MOLAR:
- KETAC®-MOLAR QUICK has the same intended use ●
- KETAC®-MOLAR QUICK is used by the same operating principle .
- KETAC®-MOLAR QUICK incorporates the same basic chemical design .
- . KETAC®-MOLAR QUICK has the same shelf life
- . KETAC®-MOLAR QUICK is manufactured and packaged using the same materials and processes
All chemical components of KETAC®-MOLAR QUICK are already part of the predicate device KETAC -MOLAR, are contained in other 510(k) cleared devices manufactured by ESPE, or are described in a pharmacopoeia. Therefore, we believe that additional biocompatibility testing is not required.
In summary the modified KETAC®-MOLAR QUICK described in this 510(k) premarket notification submission is, in our opinion, substantially equivalent to the predicate device.
Image /page/1/Picture/10 description: The image shows the text "Special 510(k) KETAC®-MOLAR QUICK" on the top line. Below that is the logo for ESPE. The logo is a stylized tree with the letters "ESPE" in bold font to the right of the tree.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming a shape resembling a bird or a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 3 2000
Dr. Andreas Petermann Manager U.S. Regulatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld, Bavaria Germany
Re: K994251 KETAC®-Molar Quick Trade Name: Regulatory Class: II Product Code: EBF Dated: December 15, 1999 Received: December 17, 1999
Dear Dr. Petermann:
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 qeneral 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 requlations 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Dr. Petermann
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.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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.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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STATEMENT OF INDICATIONS FOR USE
(As Required by 21 C.F.R. § 801.109)
510(k) Number:
K94251
Device Name:
KETAC®-MOLAR QUICK
Indications for use:
Linings for class I and II cavities filled with composite
Core build-ups
Fillings in deciduous teeth
Fillings in class I cavities located in non-
occlusal load bearing areas
Fillings in class V cavities if the esthetics are not of primary importance
Temporary fillings in class I and II cavities
Prescription use: 网
Over-the counter use □
(Division Sign-Off) familia bear for Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _699423