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.

AI/ML Overview

This document, K913343 refers to a 510(k) submission for a dental impression material named "Hydroflex". The submission uses a "substantial equivalence" claim, comparing the new device against existing predicate devices (Exaflex and Examix). This type of submission relies on demonstrating that the new device has similar performance characteristics to a legally marketed device, rather than conducting extensive clinical efficacy studies typically required for novel devices.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a pass/fail form but are implied by the comparison to predicate devices, which are assumed to meet acceptable performance standards. The "reported device performance" are the physical properties measured for the Hydroflex product line and the predicate devices. The study demonstrates that the Hydroflex varieties (Injection, Regular, Monophase, Heavy Body, Heavy Body Hard) have physical properties that are comparable to or within the range of their respective predicate devices (Exaflex and Examix).

Below is a consolidated table with the properties of Hydroflex and its predicate devices:

Table of Performance Characteristics - Hydroflex vs. Predicate Devices (Based on ISO 4823)

Test Item (ISO 4823)	Predicate Device (Exaflex/Examix)	Hydroflex
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
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
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
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	2.7
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
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

Study Proving Device Meets Acceptance Criteria:

The study presented is a comparative analysis of the physical properties of the "Hydroflex" dental impression material and its predicate devices ("Exaflex" and "Examix"), both manufactured by GC Corporation. The comparison is based on ISO 4823 standards, which outlines requirements for elastomeric dental impression materials. The data provided demonstrates that Hydroflex possesses similar material characteristics to the predicate devices across various parameters, including working time, setting time, consistency, strain in compression, recovery from deformation, linear dimensional change, detail reproduction, and compatibility with gypsum. This similarity in performance under standardized tests is the basis for the claim of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size for each test of physical properties (e.g., how many measurements were taken for working time, setting time, etc.). This kind of detail is typically found in the full test report, not usually summarized in a 510(k) abstract.
Data Provenance: The data stems from laboratory testing of the physical properties of the dental impression materials. The country of origin for the data is implied to be from the manufacturer (GC America Inc. for Hydroflex, and GC Corporation, Tokyo, Japan for Exaflex/Examix). The data is prospective in the sense that these tests were conducted on the materials as part of the submission process to demonstrate their properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This is not applicable in this context. The "ground truth" for material properties is established through standardized physical and chemical testing methods (ISO 4823), not clinical expert consensus. The reported values are direct measurements from these tests.

4. Adjudication Method for the Test Set

N/A. This is not applicable as the study involves objective physical measurements based on ISO standards, not subjective assessments requiring expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study (MRMC) is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess diagnostic performance. This submission concerns a dental material's physical properties, not diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This concept applies to AI/ML algorithms where the algorithm's performance is evaluated independently. This submission is for a physical dental impression material, not a software algorithm. The "standalone" performance here refers to the intrinsic physical properties of the material as measured in a lab.

7. The Type of Ground Truth Used

The ground truth used consists of objective physical measurements obtained through standardized laboratory tests (specifically, tests outlined in ISO 4823 for elastomeric dental impression materials). These standards define procedures for measuring characteristics such as working time, setting time, consistency, strain in compression, recovery from deformation, linear dimensional change, detail reproduction, and compatibility with gypsum. The values obtained from these tests serve as the "ground truth" for the material's properties.

8. The Sample Size for the Training Set

N/A. This concept is for AI/ML models. For this medical device (dental impression material), there isn't a "training set" in the machine learning sense. The "development" or "formulation" of the material would involve iterative testing and refinement, but this isn't a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

N/A. As mentioned above, there is no training set as this is not an AI/ML device. The "ground truth" for material development would be the desired performance characteristics based on clinical needs and existing industry standards, which are then verified through controlled laboratory testing.

Summary

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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

Performance Characteristics

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

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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

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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

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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)	ExaflexInjection	HydroflexInjection
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)	ExaflexRegular	HydroflexRegular
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)	ExaflexMonophase	HydroflexMonophase
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

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Test Item(ISO 4823)	ExamixHeavy body	HydroflexHeavy 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)	ExaflexHeavy Body	HydroflexHeavy BodyHard
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

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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

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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

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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 ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).