(46 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a dental impression material, with no mention of AI or ML.
No.
The device is used for taking intra-oral impressions, which is a diagnostic or imaging purpose, not for treating a condition.
No
Explanation: Hydroflex is an impression material used to create a replica of dentition, not to diagnose a condition. It is a tool for creating models, which can then be used for treatment planning or fabrication, but it does not provide diagnostic information itself.
No
The device description explicitly states it is a "dental silicone impression material," which is a physical substance, not software. The performance studies also detail physical properties of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for taking intra-oral impressions of a person's dentition." This is a physical process of creating a mold of the teeth and gums.
- Device Description: The device is a "dental silicone impression material." This material is used to physically capture the shape of the oral tissues.
- Lack of Diagnostic Purpose: The description does not mention any diagnostic purpose. The impression is used to create a physical replica, not to analyze biological samples or provide information for diagnosis.
- No Mention of Biological Samples: IVD devices are typically used to examine biological samples (blood, urine, tissue, etc.) to provide information about a person's health. This device interacts directly with the oral tissues to create a physical mold.
Therefore, Hydroflex is a dental material used for creating physical impressions, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Hydroflex is intended to be used for taking intra-oral impressions of a person's dentition.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The provided document presents physical properties for Hydroflex (Injection, Regular, Monophase, Heavy Body, Heavy Body Hard viscosities) and equivalence data comparing Hydroflex to the predicate device Exaflex/Examix across several test items defined by ISO 4823.
Key results from the performance characteristics are:
- better flow
- extended working time with snap set
- dimensional stability
- improved elasticity and high tear strength
Specific physical properties include:
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
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
(ISO 4823) | Exaflex
Injection | Hydroflex
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
(ISO 4823) | Exaflex
Regular | Hydroflex
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
(ISO 4823) | Exaflex
Monophase | Hydroflex
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
(ISO 4823) | Examix
Heavy body | Hydroflex
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
(ISO 4823) | Exaflex
Heavy Body | Hydroflex
Heavy Body
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 (301) 594-4618. 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.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
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 ________________________________________________________________________________________________________________________________________________________________