(111 days)
Not Found
No
The device description and intended use clearly define it as a dental impression material, a physical substance used to create molds. There is no mention of software, algorithms, data processing, or any other component that would suggest the use of AI or ML. The performance studies focus on material properties and equivalence to a predicate device, not on algorithmic performance.
No
The device is an impression material used for making dental impressions, which aids in fabricating dentures or other dental prostheses. It is not used to treat or cure a disease or condition.
No
Explanation: The device is an impression material used for fabricating dental prostheses, not for diagnosing medical conditions.
No
The device description clearly states it is a dental impression material supplied as a two-part base/catalyst formulation in cartridges, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental impressions of the oral mucosa for various dental procedures (dentures, relines, etc.). This is a physical process of capturing a mold of anatomical structures.
- Device Description: The device is a dental impression material, a substance used to create a physical mold.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) to create a physical impression.
N/A
Intended Use / Indications for Use
VPS Impression Material(Light Body) is to be used as syringeable impression materials for:
-Two-step putty-wash impression technique;
-One-step putty-wash impression technique;
- Two-step impression technique using dual viscosities ;
- Reline impressions ;
-Fabricating full or partial dentures;
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
K203824:VPS Impression Material is dental Impression Material. It complies with the requirements of ISO 4823:2015 for dental elastomeric impression materials. It is supplied as atwo-part base/catalyst formulation preloaded in a dual-barrel cartridge. The VPS Impression Material package includes four dual-barrel 50ml cartridges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa
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)
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. The subject of this premarket submission, VPS 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.
K192941 (Primary Predicate): Osstem Implant Co.,Ltd.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 19, 2021
Hygedent, Inc. Peng Wang General Manager Room 210C, Building 4, No 5 Chaoqian Road Beijing, 102299 CHINA
Re: K203824
Trade/Device Name: VPS Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: January 25, 2021 Received: January 25, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203824
Device Name VPS Impression Marterial
Indications for Use (Describe)
VPS Impression Material(Light Body) is to be used as syringeable impression materials for:
-Two-step putty-wash impression technique;
-One-step putty-wash impression technique;
-
Two-step impression technique using dual viscosities ;
-
Reline impressions ;
-Fabricating full or partial dentures;
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Chapter 6 510(k) Summary (K203824)
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 04/16/2021 |
|---|---|
| Submitter: | HYGEDENT INC |
| Add: | Room 210C, Building 4, No 5 Chaoqian Road, Science Industry |
| Park, Changping District, Beijing, P.R.China | |
| Establishment | |
| Registration Number: | 3011187729 |
| Owner/Operator | |
| Number: | 10047045 |
| Primary Contact | |
| Person: | Peng Wang (General Manager) |
| HYGEDENT INC. | |
| Tel: +85-13901284956 | |
| Email: zoe.sun@hygedent.com | |
| US Agent: | Zoe |
| HYGEDENT DENTAL INC. | |
| 11622 El Camino Real, Suite 100, San Diego, CA 92130 | |
| Phone: 858 764 2495 | |
| Email: zoesunyi@yahoo.com | |
| Device:Trade Name: | |
| Type: | VPS Impression Material |
| Light | |
| Common/Usual | |
| Name: | Impression Material |
| Classification Names: | Material, Impression |
| Regulation number: | 21 CFR 872.3660 |
| Product Code: | ELW |
| Regulation Class: | 2 |
| Predicate Device(s): | K192941 (Primary Predicate): Osstem Implant Co.,Ltd. |
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| Device Description: | K203824:VPS Impression Material is dental Impression Material. It
complies with the requirements of ISO 4823:2015 for dental elastomeric
impression materials. It is supplied as atwo-part base/catalyst
formulation preloaded in a dual-barrel cartridge. The VPS Impression
Material package includes four dual-barrel 50ml cartridges. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | K203824: VPS Impression Material(Light Body) is to be used as
syringeable impression materials for:
-Two-step putty-wash impression technique;
-One-step putty-wash impression technique;
- Two-step impression technique using dual viscosities ;
- Reline impressions : |
-Fabricating full or partial dentures;
Substantial Equivalence Matrix :
| Proposed Device | Primary Predicate Device | Remark | |
|---|---|---|---|
| Device Name | VPS Impression Material | HySil Super Fast Impression | |
| Materials | Different | ||
| Type | Light | Heavy, Mono, Light | Different |
| 510(k) No. | K203824 | K192941 | Different |
| Manufacturer | HYGEDENT INC | Osstem Implant Co.,Ltd. | Different |
| Indications | |||
| for Use: | VPS Impression Material | ||
| (Light Body) is to be used | |||
| as syringeable impression | |||
| materials for: | |||
| -Two-step putty-wash | |||
| impression technique; | |||
| -One-step putty-wash | |||
| impression technique; |
- Two-step impression | HySil Heavy Super Fast is to be
used as heavy-bodied materials for: - One-step impression technique
using single or dual viscosities; - Two-step impression technique
using dual viscosities - Functional impressions
HySil Mono Super Fast is to be
used as a medium bodied tray or | Different since the
predicate devices
have 3 types of
devices (Heavy,
Mono,Light),
while the proposed
devices have 1type |
| | | | |
| technique using dual | syringeable impression material for: of devices . | | |
| viscosities ; | - Taking impressions over | Although there are | |
| - Reline impressions ; | removable/ fixed restorations and differences in | | |
| - Fabricating full or | - implants | number of types, | |
| partial dentures; | - Functional impressions | the Indications for | |
| | - Fabricating crown and bridgework | | |
| | or inlays | Use Statements of
Light type for | |
| | - Fabricating full or partial dentures | both proposed and | |
| | - Reline impressions | predicate devices | |
| | - Use in the simultaneous mixing | are same. | |
| | technique as well as the putty- | | |
| | wash and triple tray techniques | | |
| | - Transferring root posts when | | |
| | fabricating posts and cores | | |
| | indirectly | | |
| | HySil Light Super Fast is to be | | |
| | used as syringeable impression | | |
| | materials for: | | |
| | - Two-step putty-wash impression | | |
| | technique; | | |
| | - One-step putty-wash impression | | |
| | technique; | | |
| | - Two-step impression technique | | |
| | using dual viscosities ; | | |
| | - Reline impressions ; | | |
| | - Fabricating full or partial | | |
| | dentures; | | |
| | | | |
| | - Be placed on an
impression tray (or
injected directly into
the mouth, depending
on the technique and
device) and used to
reproduce the structure
of a patient's teeth and
gums - Provide models for study
and for production of
restorative prosthetic
devices | - Be placed on an impression tray
(or injected directly into the
mouth, depending on the
technique and device) and used
to reproduce the structure of a
patient's teeth and gums - Provide models for study and
for production of restorative
prosthetic devices | Same |
| Principle of
Operation | | | |
| Description of
Material | Vinylpolysiloxane | Vinylpolysiloxane | Compose with
same affiliated
material, but
ratios of each
component in
use are different |
| Standard
Conformed | ISO 4823 | ISO 4823 | Same |
| Working Time | 1 min. 30 sec. | Over 1 min. 15 sec | Proposed devices
have longer
working time |
| Shelf-life | 2 years | 2 years | Same |
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Similarities:
S.E
The proposed devices and the predicated devices are made with same affiliated material called Vinylpolysiloxane conformed to ISO 4823 standard. Both are in 50ml cartridge with base and catalyst ratio of 1 to 1; have same indications for use; have same principle of operation; and have same shelf-life.
Differences
Compared to the predicated devices, the proposed devices have different composition ratios which results in longer working time. However, based on the results of the performance and the biocompatibility testing, the proposed and the predicated devices both passed the requirements. Also, there are differences in Indications for Use Statement since the predicated devices have 3 types of devices, Heavy, Mono and Light while the proposed devices have 1 types of devices. Although there are differences in number of types, the Indications for Use Statements of Light type for both proposed and predicated devices are same. Thus, the differences in Indications for Use Statement do not affect the substantial equivalence of proposed devices. Therefore, we stated that proposed devices (VPS Light Impression Materials) are substantially equivalent to the predicated devices (HySil Light Super Fast Impression Materials) cleared in K192941.
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 the standards referenced and are sufficient for their intended use. The subject of this premarket submission, VPS Impression Material did not require clinical studies to support substantial equivalence.
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Biocompatibility:
VPS Impression Material, the proposed device and predicate device contacts directly with the oral mucosa (3-5 minutes). The duration of contact is less than 24hours, therefore they are categorized as surface contact devices with limited contact duration.
Testing was Performed for Cytotoxicity (ISO 10993-5 ), Sensitization and Irritation( ISO 10993-10). The test results demonstrate that the proposed device VPS Impression Material is as biocompatible as the predicate device.
Conclusion:
The technical characteristics, material composition, principles of operation and indications for use of the proposed device VPS 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 VPS Impression Material is substantially equivalent to the predicate device.