(46 days)
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
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®.
Acceptance Criteria and Study for IMPREGUM® PENTA® M MONOSOFT
This response is based on the provided 510(k) summary for IMPREGUM® PENTA® M MONOSOFT (K994192).
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on modifications to an existing device (IMPREGUM® PENTA®) rather than a de novo submission. Therefore, the "acceptance criteria" are implicitly defined by the demonstration of substantial equivalence to the predicate device, IMPREGUM® PENTA®, particularly regarding its physical and mechanical properties. The key modification is explicitly stated as reduced Shore hardness. The performance is demonstrated by directly comparing the modified material's properties to the unmodified predicate.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (IMPREGUM® PENTA® M MONOSOFT) |
|---|---|---|
| Intended Use | Same as predicate device (IMPREGUM® PENTA®) | "IMPREGUM® PENTA® M MONOSOFT has the same intended use" |
| Operating Principle | Same as predicate device | "IMPREGUM® PENTA® M MONOSOFT is used by the same operating principle" |
| Chemical Design | Same basic chemical design as predicate device | "IMPREGUM® PENTA® M MONOSOFT incorporates the same basic chemical design" |
| Shelf Life | Same as predicate device | "IMPREGUM® PENTA® M MONOSOFT has the same shelf life" |
| Manufacturing/Packaging | Same materials and processes as predicate device | "IMPREGUM® PENTA® M MONOSOFT is manufactured and packaged using the same materials and processes" |
| Biocompatibility | No new biocompatibility issues raised by chemical composition | "All chemical components... are already part of the predicate device... or are contained in other 510(k) cleared impression materials... Therefore, we believe that additional biocompatibility testing is not required." |
Note regarding "Reduced Shore hardness": While this is a change in a physical property, it's presented as an improvement in "user convenience" and not as failing a specific functional acceptance criterion for the intended use. The underlying assumption is that the reduced hardness still allows the material to function effectively as an impression material for its stated indications. The document implies that this change does not negatively impact the clinical performance required for substantial equivalence. No specific quantitative targets or thresholds for Shore hardness are provided as "acceptance criteria."
2. Sample Size and Data Provenance
The document does not specify a separate "test set" and thus, no sample sizes for a test set are provided. The "study" described is a comparison of the modified device's characteristics to the predicate device.
- Sample Size for Test Set: Not explicitly stated as a separate "test set" for performance evaluation, but rather a comparison of defined properties. The document mentions "the physical and mechanical properties" being compared.
- Data Provenance: The document identifies the submitter as "ESPE Dental AG" in "Seefeld, Bavaria, Germany," suggesting the studies and data originate from Germany. The document does not specify if the data is retrospective or prospective, but given it's a comparison of material properties, it is likely based on laboratory testing.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This submission is for a material modification of a dental impression material, evaluated through physical and chemical properties, not a diagnostic device requiring expert interpretation of results. Therefore, no experts were used to establish "ground truth" in the diagnostic sense.
4. Adjudication Method
Not applicable. No "adjudication method" is described as this is not a study involving human reader interpretation or clinical outcomes requiring independent review for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study was not done. This device is a dental impression material, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No. A standalone performance study (in the context of an algorithm's performance) was not done. This is a material science modification, not an algorithm.
7. Type of Ground Truth
The "ground truth" for this submission is implicitly the established physical, mechanical, and chemical properties of the predicate device (IMPREGUM® PENTA®) and standard material science test methods. The modified device's properties are compared against these benchmarks, with the key difference (reduced Shore hardness) presented as beneficial for user convenience.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
{0}------------------------------------------------
'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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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
§ 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).