K Number

Device Name

HYGEDENT ALGINATE IMPRESSION MATERIAL

Manufacturer

HYGEDENT INC

Date Cleared

2014-05-21

(128 days)

Product Code

ELW

Regulation Number

872.3660

Intended Use

Hygedent Alginate Impression Material is irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Device Description

Hygedent Alginate Impression Material is a dust free alginate impression material with a creamy consistency for general dental practice and for orthodontics. It is presented in the form of a homogeneous orange colored powder with a nice mint flavor. The material has exceptional good elastic properties and a high tear-resistance. The impression surface is very smooth, which gives excellent gypsum compatibility.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K023466

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and chemical properties of the alginate material, with no mention of AI or ML.

Therapeutic

No
The device is an impression material used to take anatomical data for study models and the production of prosthetic devices, not to directly treat or alleviate a disease or condition.

Diagnostic

No
The document states the material is used to take anatomical data for models, not for diagnosis.

SaMD (Software as a Medical Device)

The device description clearly states it is a "dust free alginate impression material" in powder form, indicating it is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to take anatomical data of the patient's mouth for creating models and prosthetic devices. This is a physical impression process, not a diagnostic test performed on biological samples in vitro (outside the body).
Device Description: The description details a material used for creating a physical mold, not a reagent or instrument for analyzing biological specimens.
Lack of Diagnostic Claims: There are no claims about diagnosing, monitoring, or predicting any disease or condition.
Performance Studies: The performance studies focus on physical properties and equivalence to a predicate device used for the same impression purpose, not on diagnostic accuracy or clinical outcomes related to diagnosis.

IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

ELW

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's mouth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dentist

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)

Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalence to the predicate device:

・ ISO 1563:1990;
. ADA Specification No.18.1992;
Results of performance testing indicate that the grounding pad meets applicable sections of the standards referenced and are safe and as effective for their intended use. The subject of this premarket submission, Hygedent Alginate Impression Material, did not require clinical studies to support substantial equivalence.

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.

K023466

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

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).

Summary

510(k) Summary

. . . . .

: :

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	2014 Jan 04.
Submitter:	HYGEDENT INC.
	Add: Daliushu Industrial Zone Xiaotangshan Changping District, 102211,
	Beijing, P. R. China
Primary Contact Person:	Peng Wang
	General Manager
	HYGEDENT INC.
	Tel: +86-13901284956
	Fax: +86-10-60701780
Secondary Contact
Person:	Mike Gu
	Regulatory Affairs Manager
	OSMUNDA Medical Device Consulting Co., Ltd.
	Tel: (+86)-20-6232 1333
	Fax: (+86) -20-8633 0253
Device: Trade Name	Hygedent Alginate Impression Material
Common/Usual
Name:	Impression Material
Classification Names:	Material, Impression
Regulation number:	CFR 872.3660
Product Code:	ELW
Predicate Device(s):	K023466
Device Description:	Hygedent Alginate Impression Material is a dust free alginate impression
material with a creamy consistency for general dental practice and for
orthodontics. It is presented in the form of a homogeneous orange colored
powder with a nice mint flavor. The material has exceptional good elastic
properties and a high tear-resistance. The impression surface is very
smooth, which gives excellent gypsum compatibility.
Intended Use:	Hygedent Alginate Impression Material is irreversible hydrocolloids for
dental impressions used by the dentist to take the anatomical data of the
patient's mouth. The device is intended to provide models for study and
for production of restorative prosthetic devices such as gold inlays and

: :

dentures.

Technology:

All the alginates described in the premarket notification application (510k) have the following technological characteristics:

- Identical mechanism of action
- Highly similar preparation times
- Highly similar elastic recovery and accuracy

The physical properties of the proposed device and the predicate device are compared as following:

Physical Parameters	Proposed device	Predicate device
Appearance	Powder	Powder
Odor	Peppermint	Peppermint
Compression strength	0.75MPa	0.7 MPa
Compatibility with gypsum	50μm	50μm
Recovery from Deformation	96.50 %	96%

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

Hygedent Alginate Impression Material contacts directly with the oral mucosa. The duration of contact is less than 24 hours. Biocompatibility of the Material complies with ISO 10993-10. The test results demonstrate that the proposed device is biocompatible.

Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalence to the predicate device:

・ ISO 1563:1990;
. ADA Specification No.18.1992;

Results of performance testing indicate that the grounding pad meets applicable sections of the standards referenced and are safe and as effective for their intended use. The subject of this premarket submission, Hygedent Alginate Impression Material, did not require clinical studies to support substantial equivalence.

Conclusion:

HYGEDENT INC. considers the Hygedent Alginate Impression Material to be as safe, as effective, and performance is substantially equivalent to the predicate device. .

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

May 21, 2014

HYGEDENT, Incorporated Ms. Peng Wang General Manager Daliushu Industrial Zone Xiaotangshan, Changping District Beijing 102211 P.R. CHINA

Re: K140074

Trade/Device Name: Hygedent Alginate Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Il Product Code: ELW Dated: February 19, 2014 Received: February 21, 2014

Dear Ms. Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Page 2 - Ms. Wang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

140074 510(k) Number (if known): []

Device Name: Hygedent Alginate Impression Material

Common/usual name: Impression Material

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_

(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -S 2014.05.20 11:33:11 -04'00'