IMPREGUM PENTA

K992897 · Espe Dental AG · ELW · Sep 8, 1999 · Dental

Device Facts

• Record ID: K992897
• Device Name: IMPREGUM PENTA
• Applicant: Espe Dental AG
• Product Code: ELW · Dental
• Decision Date: Sep 8, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Dental impression material for: Impressions for inlay, onlay, crown, and bridge restorations Functional impressions Fixation impressions Implant impressions

Device Story

IMPREGUM® PENTA® is a polyether-based dental impression material used by dental professionals to reproduce the structure of a patient's teeth. The device is used in a clinical setting to capture accurate dental anatomy for restorative procedures, including inlays, onlays, crowns, bridges, and implants. The material is applied to the patient's oral cavity to create a physical mold, which the clinician then uses to facilitate the fabrication of dental prosthetics. This modification involves replacing one chemical ingredient with a comparable compound and adding another, while maintaining the same fundamental scientific technology and operating principle as the predicate device.

Clinical Evidence

No clinical data. The submission relies on a comparison of chemical composition and physical/mechanical properties between the modified and unmodified versions of the device, supported by design control activities.

Technological Characteristics

Polyether-based dental impression material. Classified as an impression material under 21 C.F.R. § 872.3660. The device utilizes a chemical setting reaction to reproduce dental structures. No software or electronic components.

Indications for Use

Indicated for dental patients requiring impressions for inlay, onlay, crown, and bridge restorations, functional impressions, fixation impressions, and implant impressions.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• IMPREGUM® PENTA® (K992897)

Submission Summary (Full Text)

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8 1999 SEP

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### 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 |
| E-mail | [e-mail] |
| 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.

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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.

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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 □