(45 days)
K 953374
Not Found
No
The 510(k) summary describes a dental impression material and its intended use and physical properties. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of such technologies. The description focuses on the material composition and dispensing method.
No.
The device is described as an impression material intended to reproduce the structure of a patient's teeth, which is a diagnostic rather than a therapeutic function.
No
Explanation: The device is an impression material used to reproduce the structure of a patient's teeth for restorations, not to diagnose a medical condition.
No
The device is described as a dental impression material, which is a physical substance used to create a mold of teeth. The description explicitly mentions it is a "polyether based impression material" and is used for "mixing, dosing and dispensing". This indicates a physical product, 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 to create dental impressions for various restorative procedures. This is a physical process of reproducing the structure of teeth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is classified as an "impression material" and its function is to reproduce the structure of teeth. This aligns with a physical impression process, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a dental impression material used for restorative and functional purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dental impression material for mixing and dispensing in a GARANT® dispenser:
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
IMPREGUM® GARANT® L DUOSOFT is a low viscosity impression material for mixing, dosing and dispensing in the GARANT® dispenser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
K 953374
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
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
Image /page/0/Picture/0 description: The image shows a sequence of digits and a letter, all rendered in a bold, black font. The sequence starts with the letter 'K', followed by the numbers '994190'. The characters are closely spaced and have a uniform appearance, suggesting they might be part of a code or identification number.
JAN 2 7 2000
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV.
Submitter
| 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 10, 1999 | |
| Name of Device | ||
| Proprietary Name: | IMPREGUM® GARANT® L DuoSOFT | |
| Classification Name: | Impression material | |
| Common Name: | Polyether based impression material | |
| Predicate Device | ||
| PERMADYNE® GARANT® | K 953374 |
Description for the Premarket Notification
IMPREGUM® GARANT® L DUOSOFT is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.
ESPE is submitting this Special 510(k) for modifications to its polyether based impression material PERMADYNE® GARANT®. IMPREGUM® GARANT® L DUOSOFT is
Image /page/0/Picture/8 description: The image shows the text "Special 510(k) IMPREGUM® GARANT® L DUOSOFT" in a clear, sans-serif font. Below the text is the logo of ESPE, which includes a stylized tree within a square. The text and logo are aligned to the left, creating a clean and professional appearance.
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intended to be used together with ESPE's new impression material IMPREGUM® PENTA® H DUOSOFT in a one-step and two-step "putty wash" technique.
Like PERMADYNE® GARANT®, IMPREGUM® GARANT® L DUOSOFT is a low viscosity impression material for mixing, dosing and dispensing in the GARANT® dispenser.
IMPREGUM® GARANT® L DUOSOFT has the same fundamental scientific technology, the same intended use and is applied by the same technique as PERMADYNE® GARANT®, therefore, we believe these modifications are eligible for the Special 510(k) review process.
In this Special 510(k) Device Modification submission the chemical composition, the physical and mechanical properties, and the indications for use of both the unmodified PERMADYNE® GARANT® and the modified IMPREGUM® GARANT®L DUOSOFT are compared. Furthermore, ESPE's design control activities are shortly explained.
The modified impression material IMPREGUM® GARANT® L DUOSOFT has the following similarities to the unmodified PERMADYNE® GARANT®:
- IMPREGUM® GARANT® L DUOSOFT has the same intended use .
- IMPREGUM® GARANT® L DUOSOFT is used by the same operating principle ●
- IMPREGUM® GARANT® L DUOSOFT incorporates the same basic chemical ● design
- IMPREGUM® GARANT® L DUOSOFT has the same shelf life .
- IMPREGUM® GARANT® L DUOSOFT is manufactured and packaged using ● the same materials and processes
All chemical components of IMPREGUM® GARANT® L DUOSOFT are already part of the predicate device PERMADYNE® GARANT® or are contained in other 510(k) cleared impression materials manufactured by ESPE. Therefore, we believe that additional biocompatibility testing is not required.
In summary the modified IMPREGUM® GARANT® L DUOSOFT described in this submission is, in our opinion, substantially equivalent to the predicate device.
Image /page/1/Picture/12 description: The image shows the text "Special 510(k) IMPREGUM® GARANT® L DUOSOFT" in a sans-serif font. Below this text is the logo for ESPE, which includes a stylized tree. The text and logo are all in black and are set against a white background. The image appears to be a product label or advertisement.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2000
Dr. Andreas Petermann Manager, U.S. Regulatory Affairs ESPE Dental AG - ESPE Platz D-82229 Seefeld, Bavaria, Germany
Re: K994190 Impregum® Garant® L DuoSoft Trade Name: Requlatory Class: II Product Code: ELW December 10, 1999 Dated: Received: December 13, 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 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 Requlations, 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 requlatory 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
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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 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" (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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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D. Statement of Indications for Use
Device Name:
IMPREGUM® GARANT® L DUOSOFT
Indications for use:
Dental impression material for mixing and dispensing in a GARANT® dispenser:
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital j 1: "An Number _
Prescription
DEVICE
Special 510(k) IMPREGUM® GARANT® L DuoSOFT
ESPE
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