(12 days)
Dental impression material for:
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
The modified IMPREGUM® PENTA® 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 of its polyether based impression material IMPREGUM® PENTA®. In particular one ingredient will be exchanged by a chemical compound with comparable character and another one will be added.
1. Acceptance Criteria and Device Performance:
The document does not explicitly state quantitative acceptance criteria or device performance metrics for the modified IMPREGUM® PENTA® in a clear table format, as this is a Special 510(k) focused on demonstrating substantial equivalence. Instead, the "acceptance" is based on the material meeting the same fundamental scientific technology, intended use, operating principle, basic chemical design, shelf life, and manufacturing/packaging processes as the predicate device.
2. Sample Size and Data Provenance:
No studies with specific sample sizes of test sets are described. The submission relies on a comparison of the modified and unmodified device characteristics rather than a standalone clinical or performance study with a distinct test set. The data provenance is effectively "internal" to the manufacturer (ESPE Dental AG, Germany), comparing their own modified product to their existing predicate product.
3. Number and Qualifications of Experts for Ground Truth:
Not applicable. This type of submission does not involve a test set requiring expert ground truth establishment in the traditional sense of a diagnostic or therapeutic device study. The "ground truth" here is a comparison of product specifications and performance in a manufacturing/testing context.
4. Adjudication Method for the Test Set:
Not applicable, as there is no specifically defined "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a diagnostic imaging or clinical decision support device where human readers interact with AI.
6. Standalone (Algorithm Only) Performance Study:
Not applicable, as this is an impression material, not a software algorithm.
7. Type of Ground Truth Used:
The "ground truth" for demonstrating substantial equivalence relies on:
- Physical and Mechanical Properties: Comparative tests of the material's characteristics (implied, though specific data is not provided in this summary).
- Chemical Composition: Comparison of the components between the modified and unmodified devices.
- Intended Use, Operating Principle, Shelf Life, Manufacturing: Demonstrating consistency with the predicate device.
8. Sample Size for the Training Set:
Not applicable. This product is a medical device (impression material), not an AI algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
8 1999 SEP
Image /page/0/Picture/2 description: The image shows a sequence of digits and a letter, all in bold black font. The sequence starts with the letter 'K', followed by the numbers '992897'. The characters are closely spaced and have a uniform appearance, suggesting they might be part of a code, serial number, or identifier. The background is plain white, which makes the black characters stand out.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV.
Submitter
| Name: | 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 of U.S. Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| Andreas_Petermann@ESPE.de | |
| Date: | August 25, 1999 |
| Name of Device |
Classification Name: .........................................................................................................................................................
Common Name:..................................................................................................................................................................
Predicate Device
IMPREGUM® PENTA® .............................................................................................................................................................
Description for the Premarket Notification
The modified IMPREGUM® PENTA® 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 of its polyether based impression material IMPREGUM® PENTA®. In particular one ingredient will be ex-
Image /page/0/Picture/14 description: The image contains the text "Special 510(k) IMPREGUM® PENTA®" in a bold, sans-serif font. Below the text is the logo for ESPE, which includes a stylized leaf graphic to the left of the word "ESPE", which is also in a bold, sans-serif font. The logo is black and white.
{1}------------------------------------------------
2 of 2
changed by a chemical compound with comparable character and another one will be added. The modified IMPREGUM® PENTA® has the same fundamental scientific technology and the same intended use, therefore, we believe these modifications are eligible for the Special 510(k) 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® are compared. Furthermore, ESPE's design control activities are shortly explained.
The modified impression material IMPREGUM® PENTA® has the following similarities to the unmodified IMPREGUM® PENTA®:
- IMPREGUM® PENTA® (modified) has the same intended use ●
- IMPREGUM® PENTA® (modified) is used by the same operating principle .
- IMPREGUM® PENTA® (modified) incorporates the same basic chemical de-. sign
- IMPREGUM® PENTA® (modified) has the same shelf life .
- IMPREGUM® PENTA® (modified) is manufactured and packaged using the . same materials and processes
In summary the modified IMPREGUM® PENTA® described in this 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) IMPREGUM® PENTA®" at the top. Below this text is the logo for ESPE, which features a stylized tree-like symbol next to the word "ESPE" in a bold, sans-serif font. The logo and text are all in black and white.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol that resembles a stylized caduceus, which is a symbol often associated with healthcare organizations.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 8 1999
Dr. Andreas Petermann Regulatory Affairs ESPE Dental AG ESPE Plaza D-82229 Seefeld, Bavaria Germany
K992897 Re : Impregum® Penta® . Trade Name: Regulatory Class: II Product Code: ELW Dated: August 25, 1999 Received: August 27, 1999
Dear Dr. Petermann:
We have reviewed your Section 510(k) notification of intent to we have leviewed jour referenced above and we have determined the marker is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate use stated in the enough, 1976, the enactment date of the commerce prior amendments, or to devices that have been redled bevest imecomance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). "You may, therefore, rood, bray, and o, subject to the general 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 Existing major be subject to such additional controls. 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 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
{3}------------------------------------------------
Page 2 - Dr. Petermann
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 debtired in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marrice 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) 594-4690. 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 ene regaración Shoroson" (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
{4}------------------------------------------------
Statement of Indications for Use
Device Name:
IMPREGUM® PENTA®
Indications for use:
Dental impression material for:
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
Suses Rumpres
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K92897
Prescription use:区
Over-the counter use □
§ 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).