HYDROFLEX

K973343 · GC America, Inc. · ELW · Oct 21, 1997 · Dental

Device Facts

• Record ID: K973343
• Device Name: HYDROFLEX
• Applicant: GC America, Inc.
• Product Code: ELW · Dental
• Decision Date: Oct 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Hydroflex is intended to be used for taking intra-oral impressions of a person's dentition.

Device Story

Hydroflex is a vinyl polysiloxane dental impression material. It is used by dental professionals to create intra-oral impressions of a patient's dentition. The material is available in five viscosities: Regular, Injection, Monophase, Heavy Body, and Heavy Body Hard. After application, the impression is poured with dental stone or plaster to create a hard replica of oral tissues. The device provides improved flow, extended working time with a snap set, dimensional stability, and high tear strength. It is used in a clinical dental setting.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4823 standards for dental impression materials. Comparative data provided for five viscosities (Injection, Regular, Monophase, Heavy Body, Heavy Body Hard) against predicate Exaflex/Examix, measuring working time, setting time, consistency, strain in compression, recovery from deformation, linear dimensional change, detail reproduction, and gypsum compatibility.

Technological Characteristics

Vinyl polysiloxane dental impression material. Available in five viscosities. Performance characteristics include improved flow, extended working time, snap set, dimensional stability, and high tear strength. Testing conducted per ISO 4823 standards.

Indications for Use

Indicated for taking intra-oral impressions of human dentition.

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

• Exaflex/Examix (K955932)

Submission Summary (Full Text)

{0}------------------------------------------------

K913343

Attachment G

#### 510(k) Summary of OCT 2 1 1997 Safety and Effectiveness Data

47 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2

vinyl polysiloxane impression material Device Generic Name:

Hydroflex - Modified Device Trade Name:

Applicant's Name and Address:

GC AMERICA INC. 3737 West 127th Street Alsip, IL 60803

### II. 12 Indications = 2 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 =

Hydroflex is intended to be used for taking intra-oral impressions of a person's dentition.

### III. Co Device Description of the Carrier Comments of Career

Hydroflex is a dental silicone impression material used for making intra-oral impressions. The resulting impression is poured in dental stone or plaster to form a hard replica of the oral tissues. This product will be available in five viscosities: Regular, Injection, Monophase, Heavy Body and Heavy Body Hard.

#### Performance Characteristics

- � better flow
- extended working time with snap set ﻬ
- dimensional stability �
- improved elasticity and high tear strength �

{1}------------------------------------------------

## Physical Properties:

MALANGALITY-THE---------------------------------------------------------------------------------------------------------------------------------------------------------------

| Hydroflex Injection | |
|--------------------------------|-------|
| Total working time (min:sec) | 2:45 |
| Setting time (min:sec) | 5:00 |
| Consistency (mm) | 40 |
| Strain in compression (%) | 10.0 |
| Recovery from deformation (%) | 99.7 |
| Linear dimensional change (%) | - 0.1 |
| Detail reproduction (mm) | 0.020 |
| Compatibility with gypsum (mm) | 0.020 |

| Hydroflex Regular | |
|--------------------------------|-------|
| Total working time (min:sec) | 2:00 |
| Setting time (min:sec) | 4:00 |
| Consistency (mm) | 35 |
| Strain in compression (%) | 10.5 |
| Recovery from deformation (%) | 99.6 |
| Linear dimensional change (%) | - 0.1 |
| Detail reproduction (mm) | 0.020 |
| Compatibility with gypsum (mm) | 0.020 |

| Hydroflex Monophase | |
|--------------------------------|-------|
| Total working time (min:sec) | 2:00 |
| Setting time (min:sec) | 4:00 |
| Consistency (mm) | 36 |
| Strain in compression (%) | 2.7 |
| Recovery from deformation (%) | 99.7 |
| Linear dimensional change (%) | - 0.1 |
| Detail reproduction (mm) | 0.020 |
| Compatibility with gypsum (mm) | 0.020 |

{2}------------------------------------------------

| Hydroflex Heavy Body | |
|--------------------------------|-------|
| Total working time (min:sec) | 2:00 |
| Setting time (min:sec) | 4:00 |
| Consistency (mm) | 32 |
| Strain in compression (%) | 2.7 |
| Recovery from deformation (%) | 99.7 |
| Linear dimensional change (%) | - 0.1 |
| Detail reproduction (mm) | 0.050 |
| Compatibility with gypsum (mm) | 0.050 |

| Hydroflex Heavy Body Hard | |
|--------------------------------|-------|
| Total working time (min:sec) | 2:00 |
| Setting time (min:sec) | 4:00 |
| Consistency (mm) | 32 |
| Strain in compression (%) | 2.0 |
| Recovery from deformation (%) | 99.0 |
| Linear dimensional change (%) | - 0.1 |
| Detail reproduction (mm) | 0.050 |
| Compatibility with gypsum (mm) | 0.050 |

{3}------------------------------------------------

# IV. Equivalence Data - Equivale - Presenter Page Cara Carane Carane Ca

and the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states of the states

| Test Item<br>(ISO 4823) | Exaflex<br>Injection | Hydroflex<br>Injection |
|--------------------------------|----------------------|------------------------|
| Total working time (min:sec) | 2:45 | 2:45 |
| Setting time (min:sec) | 5:00 | 5:00 |
| Consistency (mm) | 40 | 40 |
| Strain in compression (%) | 5.2 | 10.0 |
| Recovery from deformation (%) | 99.6 | 99.7 |
| Linear dimensional change (%) | - 0.1 | - 0.1 |
| Detail reproduction (mm) | 0.020 | 0.020 |
| Compatibility with gypsum (mm) | 0.020 | 0.020 |

Marketed Device: Exaflex/Examix (K955932) - GC Corporation, Tokyo, Japan 1

| Test Item<br>(ISO 4823) | Exaflex<br>Regular | Hydroflex<br>Regular |
|--------------------------------|--------------------|----------------------|
| Total working time (min:sec) | 1:45 | 2:00 |
| Setting time (min:sec) | 4:00 | 4:00 |
| Consistency (mm) | 39 | 35 |
| Strain in compression (%) | 4.5 | 10.5 |
| Recovery from deformation (%) | 99.6 | 99.6 |
| Linear dimensional change (%) | - 0.1 | - 0.1 |
| Detail reproduction (mm) | 0.020 | 0.020 |
| Compatibility with gypsum (mm) | 0.020 | 0.020 |

| Test Item<br>(ISO 4823) | Exaflex<br>Monophase | Hydroflex<br>Monophase |
|--------------------------------|----------------------|------------------------|
| Total working time (min:sec) | 1:45 | 2:00 |
| Setting time (min:sec) | 4:00 | 4:00 |
| Consistency (mm) | 35 | 36 |
| Strain in compression (%) | 2.7 | 2.7 |
| Recovery from deformation (%) | 99.7 | 99.7 |
| Linear dimensional change (%) | - 0.1 | - 0.1 |
| Detail reproduction (mm) | 0.020 | 0.020 |
| Compatibility with gypsum (mm) | 0.020 | 0.020 |

{4}------------------------------------------------

| Test Item<br>(ISO 4823) | Examix<br>Heavy body | Hydroflex<br>Heavy Body |
|--------------------------------|----------------------|-------------------------|
| Total working time (min:sec) | 2:00 | 2:00 |
| Setting time (min:sec) | 4:00 | 4:00 |
| Consistency (mm) | 32 | 32 |
| Strain in compression (%) | 2.5 | 2.5 |
| Recovery from deformation (%) | 99.4 | 99.7 |
| Linear dimensional change (%) | - 0.1 | - 0.1 |
| Detail reproduction (mm) | 0.050 | 0.050 |
| Compatibility with gypsum (mm) | 0.050 | 0.050 |

| Test Item<br>(ISO 4823) | Exaflex<br>Heavy Body | Hydroflex<br>Heavy Body<br>Hard |
|--------------------------------|-----------------------|---------------------------------|
| Total working time (min:sec) | 2:00 | 2:00 |
| Setting time (min:sec) | 4:00 | 4:00 |
| Consistency (mm) | 32 | 32 |
| Strain in compression (%) | 2.5 | 2.0 |
| Recovery from deformation (%) | 99.4 | 99.0 |
| Linear dimensional change (%) | - 0.1 | - 0.1 |
| Detail reproduction (mm) | 0.050 | 0.050 |
| Compatibility with gypsum (mm) | 0.050 | 0.050 |

and the comments of the comments of

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT 2 1 1997

Mr. Terry Joritz Director-Regulatory Affairs and Quality Control GC America Incorporated 3737 West 127th Street Chicago, Illinois 60658

K973343 Re : Trade Name: Hydroflex Regulatory Class: II Product Code: ELW Dated: September, 2 1997 Received: September 5, 1997

Dear Mr. Joritz:

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 requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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

{6}------------------------------------------------

Page 2 - Mr. Joritz

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 regulation (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.fida.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo Directd Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

{7}------------------------------------------------

K973343

### ATTACHMENT H

### INDICATIONS FOR USE

Device Name:

Hydroflex - Modification

Indications for use:

Hydroflex is intended to be used for taking intra-oral impressions of a person's dentition

(

(Division Sign-O Division of Dental, Infection Control, and General Hospital Devices 15973343 510/k) Number ________________________________________________________________________________________________________________________________________________________________