(46 days)
IMPREGUM® PENTA®
K 991913
No
The description focuses on the material properties (Shore hardness) and its use with an automatic mixing device, with no mention of AI or ML.
No.
This device is an impression material used to reproduce the structure of a patient's teeth for dental restorations, not to treat or cure a disease or condition.
No
Explanation: The device is a dental impression material used to reproduce the structure of teeth, not to diagnose a condition.
No
The device description clearly states it is an "impression material," which is a physical substance, not software. It is intended to be used with a mixing device, which is also hardware.
Based on the provided text, 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 and functional purposes. 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 description clearly states it is an "impression material" intended to "reproduce the structure of a patient's teeth." It is classified under 21 C.F.R. § 872.3660, which is the regulation for impression materials, not IVDs.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of substances, or diagnostic information being derived from the material itself.
Therefore, based on the provided information, IMPREGUM® PENTA® M MONOSOFT is a dental impression material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Dental impression material for automatic mixing and dispensing in a PENTAMIX® or PEN-TAMIX® 2 mixing device, resp.:
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® PENTA® M MONOSOFT 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 IMPREGUM® PENTA®. The modified material is characterized by its reduced Shore hardness in comparison to IMPREGUM® PENTA®. The reduced Shore hardness of the set impression material results in increased user convenience because the set impression is easier to remove from the mouth. As an additional effect of the reduced Shore hardness, slight undercuts have no longer to be blocked out. The name of the modified material will be, however, IMPREGUM® PENTA® M MONOSOFT.
Like IMPREGUM® PENTA®, IMPREGUM® PENTA® M MONOSOFT is an impression material designed for the monophase technique. Like for example IMPREGUM® PENTA® and PERMADYNE® PENTA®, IMPREGUM® PENTA® MONOSOFT is another material intended to be used in ESPE's automatic mixing, dosing and dispensing device, PENTAMIX®. PENTAMIX® 2 received recently 510(k) clearance (K 991913).
IMPREGUM® PENTA® M MONOSOFT has the same fundamental scientific technology, the same intended use and is applied by the same technique as IMPREGUM® PENTA®, 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 IMPREGUM® PENTA® and the modified IMPREGUM® PENTA® M MONOSOFT are compared. Furthermore, ESPE's design control activities are shortly explained.
The modified impression material IMPREGUM® PENTA® M MONOSOFT has the following similarities to the unmodified IMPREGUM® PENTA®:
- IMPREGUM® PENTA® M MONOSOFT has the same intended use ●
- IMPREGUM® PENTA® M MONOSOFT is used by the same operating principle .
- IMPREGUM® PENTA® M MONOSOFT incorporates the same basic chemical . design
- IMPREGUM® PENTA® M MONOSOFT has the same shelf life .
- IMPREGUM® PENTA® M MONOSOFT is manufactured and packaged using ● the same materials and processes
All chemical components of IMPREGUM® PENTA® M MONOSOFT are already part of the predicate device IMPREGUM® PENTA® or are contained in other 510(k) cleared impression materials manufactured by ESPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth / mouth
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.
IMPREGUM® PENTA®
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.
K 991913
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).
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'JAN 2 8 2000
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV.
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: | |||
|---|---|---|---|
| ------------------- | -- | -- | -- |
Classification Name: .........................................................................................................................................................
Common Name:..................................................................................................................................................................
Predicate Device
IMPREGUM® PENTA® .............................................................................................................................................................
Description for the Premarket Notification
IMPREGUM® PENTA® M MONOSOFT 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 IMPREGUM® PENTA®. The modified material is characterized by
1
its reduced Shore hardness in comparison to IMPREGUM® PENTA®. The reduced Shore hardness of the set impression material results in increased user convenience because the set impression is easier to remove from the mouth. As an additional effect of the reduced Shore hardness, slight undercuts have no longer to be blocked out. The name of the modified material will be, however, IMPREGUM® PENTA® M MONOSOFT.
Like IMPREGUM® PENTA®, IMPREGUM® PENTA® M MONOSOFT is an impression material designed for the monophase technique. Like for example IMPREGUM® PENTA® and PERMADYNE® PENTA®, IMPREGUM® PENTA® MONOSOFT is another material intended to be used in ESPE's automatic mixing, dosing and dispensing device, PENTAMIX®. PENTAMIX® 2 received recently 510(k) clearance (K 991913).
IMPREGUM® PENTA® M MONOSOFT has the same fundamental scientific technology, the same intended use and is applied by the same technique as IMPREGUM® PENTA®, 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 IMPREGUM® PENTA® and the modified IMPREGUM® PENTA® M MONOSOFT are compared. Furthermore, ESPE's design control activities are shortly explained.
The modified impression material IMPREGUM® PENTA® M MONOSOFT has the following similarities to the unmodified IMPREGUM® PENTA®:
- IMPREGUM® PENTA® M MONOSOFT has the same intended use ●
- IMPREGUM® PENTA® M MONOSOFT is used by the same operating principle .
- IMPREGUM® PENTA® M MONOSOFT incorporates the same basic chemical . design
- IMPREGUM® PENTA® M MONOSOFT has the same shelf life .
- IMPREGUM® PENTA® M MONOSOFT is manufactured and packaged using ● the same materials and processes
Image /page/1/Picture/10 description: The image shows the text "Special 510(k) IMPREGUM® PENTA® M MONOSOFT" in black font. Below this text is the logo for ESPE. The logo consists of a square outline with a stylized tree inside, followed by the word "ESPE" in bold, sans-serif font. The text and logo are aligned horizontally.
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All chemical components of IMPREGUM® PENTA® M MONOSOFT are already part of the predicate device IMPREGUM® PENTA® 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® PENTA® M MONOSOFT described in this 510(k) premarket notification submission is, in our opinion, substantially equivalent to the predicate device.
Image /page/2/Picture/2 description: The image shows the text "Special 510(k) IMPREGUM® PENTA® M MONOSOFT" in black font. Below this text is the logo for ESPE, which includes a stylized leaf design. The text and logo are aligned horizontally. The text appears to be a product name or a description of a medical device.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling three abstract human profiles or faces stacked on top of each other. The symbol is positioned to the right of the circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2000
Dr. Andreas Petermann Manager, U.S. Regulatory Affairs ESPE Dental AG - ESPE Platz D-82229 Seefeld, Bavaria, Germany
K994192 Re : Impregum® Penta® M MonoSoft 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, labelinq, 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. ਸ 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Dr. Petermann
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 findinq of substantial eguivalence 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.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
5
STATEMENT OF INDICATIONS FOR USE
(As Required by 21 C.F.R. § 801.109)
510(k) Number:
Device Name:
IMPREGUM® PENTA® M MONOSOFT
Indications for use:
Dental impression material for automatic mixing and dispensing in a PENTAMIX® or PEN-TAMIX® 2 mixing device, resp.:
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
Prescription use: Ø
Over-the counter use □
Susan Runnes
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number