(131 days)
No
The device description and intended use clearly describe a traditional alginate impression material, with no mention of AI or ML capabilities. The performance studies focus on material properties, not algorithmic performance.
No
Explanation: The device is an impression material used to create models of the patient's mouth for study and production of restorative prosthetic devices. It does not provide therapy or treatment itself.
No
Explanation: The device, HygePLUS Alginate Impression Material, is used to take anatomical data for creating models for study and production of restorative prosthetic devices. It does not perform any diagnosis or provide diagnostic information.
No
The device is a physical material (alginate powder) used for taking dental impressions, not a software application.
Based on the provided information, the HygePLUS Alginate Impression Material 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 for study and production of restorative prosthetic devices. This is a physical impression process, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's a powder used to create a physical mold.
- Lack of Diagnostic Claims: There are no claims of diagnosing any disease or condition.
- No Mention of Biological Samples: The process involves taking an impression of the oral cavity, not analyzing biological samples like blood, urine, or tissue.
IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The HygePLUS Alginate Impression Material does not fit this definition.
N/A
Intended Use / Indications for Use
HygePLUS 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.
Product codes
ELW
Device Description
HygePLUS Alginate Impression Material is a alginate impression material for general dental practice and for orthodontics. It is presented in the form of a homogeneous yellow powder with spearmint flavour.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's mouth, oral cavity
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.
Results of performance testing indicate that the grounding pad meets applicable sections of the standards referenced and are sufficient for their intended use.
Biocompatibility testing was Performed for cytoxicity (ISO 10993-5 ),sensitizization and irritation( ISO 10993-10).The test results demonstrate that the proposed device HygePLUS Alginate Impression Material is biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Compatibility with gypsum: complies
Elastic recovery: 97.4%
Strain in compression: 16%
Compressive strength: 1.00 MPa
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three profiles facing to the right, representing the human element of the department's mission.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2017
Hygedent Inc. Peng Wang General Manager Daliushu Industrial Zone Xiaotangshan Changping District 102211 Beijing, 102211 CHINA
Re: K170812
Trade/Device Name: HygePLUS Alginate Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: April 20, 2017 Received: May 5, 2017
Dear Peng 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (21 CFR 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.
Mary S. Runner -S
for
Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Chapter 5 Indications for Use Statement INDICATIONS FOR USE STATEMENT
510(K) Number if known:K170812
Device Name: HygePLUS Alginate Impression Material
Indications For Use:
HygePLUS 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.
| Prescription Use X | AND/OR | Over-The-Counter Usee |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDEDD
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 03/10/2017 | |||
|---|---|---|---|---|
| Submitter: | HYGEDENT INC | |||
| Add : | Daliushu Industrial Zone Xiaotangshan Changping District | |||
| Beijing102211, P. R. China | ||||
| Establishment | ||||
| Registration Number: | 3011187729 | |||
| Owner/Operator | ||||
| Number: | 10047045 | |||
| Primary | ||||
| Person: | Contact | Peng Wang | ||
| General Manager | ||||
| HYGEDENT INC. | ||||
| Tel: +85-13901284956 | ||||
| email: zoe.sun@hygedent.com | ||||
| US Agent: | RICHARD TING | |||
| TING ORTHODONTIC LAB,INC | ||||
| 2138 South Broad Street | ||||
| Philadelphia | ||||
| Phila , PA 19145 | ||||
| Phone: 215 4688168 Ext | ||||
| Fax: 215 4685335 | ||||
| Email: Tingdental@Yahoo.Com | ||||
| Device:Trade Name : | HygePLUS Alginate Impression Material | |||
| Common/Usual | ||||
| Name: | Impression Material | |||
| Classification Names: | Material, Impression |
4
Regulation number: 21 CFR 872.3660 Product Code: ELW Predicate Device(s): Primary Predicate Device: K140074 : Hygedent Inc. Hygedent Alginate Impression Material Reference Predicate Device: K023466 : Cavex Holland Tulip Alginate Impression Material
Device Description:
HygePLUS Alginate Impression Material is a alginate impression material for general dental practice and for orthodontics. It is presented in the form of a homogeneous yellow powder with spearmint flavour.
Comparison of
Indications for Use: HygePLUS 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 qold inlays and dentures.
K140074: 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.
K023466 : Tulip Alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth . It is a general purpose impression material for making study models, first impressions for the construction of
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5
individual trays, situation models, orthodontic impressions etc.
Indications for Use
- HygePLUS Alginate impression Material Is comparable to other Discussion: irreversible hydrocolloid impression materials on the market, such as Hygedent Alginate Impression Material (K140074) and Tulip Alginate impression material (K023466).the devices have the same intended use and except for minor differences in composition to achieve certain features such as rapid setting or elasticity, tear resistance employ the same alginate-based hydrocolloid chemistry. All three products may be employed in the same clinical applications. The difference between HygePLUS Alginate impression Material and the declared predicate devices lie in the selection and relative percentages of the additives, all of which are common for irreversible-hydrocolloid impression materials.
Technology
- The technology for the proposed device HygePLUS Alginate characteristics: impression Material is comparable to the predicate device. Basically the alginate, a soluble salt of alginate (extracted from brown seaweed), serves as the thickener for water. It reacts chemically with calcium sulphate to make the paste harden into a solid impression. The fillers (diatomaceous earth) give the mixture its mechanical strength. A retarder, sodium pyrophosphate, is used for achieving the required hardening-time, sufficient to mix, apply and take a proper impression and setting time in the mouth. Besides, stabilizers and pigments are added.
6
Technological characteristics
Discussion: _ Proposed device and Primary Predicate Device (K140074), have the same raw materials,except for minor differences in proportion. This difference does not affect the safety and effectiveness.
Performance data: The physical properties of the proposed device and the predicate device are compared as following:
| Physical
Parameters | Proposed
device | Primary
predicate
device | Reference
predicate
device | ADA18
Requireme
nts |
|------------------------------|---------------------|--------------------------------|----------------------------------|---------------------------|
| | K170812 | K140074 | K023466 | |
| | Hygedent
Inc. | Hygedent
Inc. | Cavex
holland | |
| | HygePLUS | Hygedent | Tulip | |
| Appearance | Powder | Powder | Powder | |
| Color | Yellow | Red | Yellow | |
| Flavor | spearmint
flavor | Mint flavor | Mint flavor | |
| Compatibility
with gypsum | complies | complies | complies | 0-50μm |
| Elastic
recovery | 97.4% | 96.50 % | 96% | > 95% |
| Strain in
compression | 16% | 14.70% | 14% | 5-20% |
| Compressive
strength | 1.00 MPa | 0.75 MPa | 0.7 MPa | > 0.35MPa |
Performance tests Discussion:
Although there is little difference for Elastic recovery, Strain in compression, Compressive strength of Proposed device and Primary Predicate Device(K140074), Reference Predicate Device(K023466), they comply with ADA Spec No.18 recommendations. This difference does not affect the safety and effectiveness.
Summary of Non-Clinical Tests:
Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalence to the predicate device.
Results of performance testing indicate that the grounding pad meets applicable sections of
7
the standards referenced and are sufficient for their intended use. The subject of this premarket submission, HygePLUS Alginate Impression Material did not require clinical studies to support substantial equivalence.
Biocompatibility :
HygePLUS Alginate Impression Material, the primary predicate device and Reference Predicate Device contacts directly with the oral mucosa (3-5 minutes). The duration of contact is less than 24 hours, therefore they are categorized as surface contact devices with limited contact duration. Testing was Performed for cytoxicity (ISO 10993-5 ),sensitizization and irritation( ISO 10993-10).The test results demonstrate that the proposed device HygePLUS Alginate Impression Material is biocompatible .
Conclusion:
The technical characteristics, material composition, principles of operation and indications for use of the proposed device HygePLUS Alginate impression Material is comparable to the predicate device. The few differences do not affect the safety and effectiveness of the proposed device. Therefore, Hygedent Inc. considers that HygePLUS Alginate impression Material is substantially equivalent to the predicate device.