IMPREGUM GARANT L DUOSOFT

K994190 · Espe Dental AG · ELW · Jan 27, 2000 · Dental

Device Facts

• Record ID: K994190
• Device Name: IMPREGUM GARANT L DUOSOFT
• Applicant: Espe Dental AG
• Product Code: ELW · Dental
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended 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

Device Story

IMPREGUM® GARANT® L DUOSOFT is a polyether-based dental impression material. It functions as a low-viscosity material used for capturing dental structures. The device is designed for use with the GARANT® dispenser system, which facilitates mixing, dosing, and dispensing. It is intended for use by dental professionals in a clinical setting to create impressions for various restorative procedures, including inlays, onlays, crowns, bridges, and implants. The output is a physical impression of the patient's teeth and oral structures, which the clinician uses to fabricate dental restorations. The device benefits the patient by enabling the creation of accurate dental prosthetics.

Clinical Evidence

No clinical data. Substantial equivalence is supported by comparison of chemical composition, physical/mechanical properties, and design control activities.

Technological Characteristics

Polyether-based impression material. Low viscosity. Form factor: cartridge for use with GARANT® dispenser. Principle of operation: manual mixing and dispensing via dispenser system. No software or electronic components.

Indications for Use

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

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

• PERMADYNE® GARANT® (K953374)

Submission Summary (Full Text)

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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.<br>Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 | |
| Fax: | 011-49-8152-700 1869 | |
| E-mail | [e-mail] | |
| 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 [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
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 [phone] or [phone] 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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