(139 days)
No
The device description and performance studies focus on the physical properties and performance of a dental impression material, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is an impression material used to reproduce the structure of teeth and gums, not to treat a disease or condition.
No
Explanation: The device is an impression material used to reproduce the structure of teeth and gums. Its function is to create a mold, not to diagnose a medical condition or disease. The performance metrics focus on material properties relevant to impression taking, not diagnostic accuracy.
No
The device description clearly states it is a "dental Impression Material" supplied as a "two-part base/catalyst formulation preloaded in a dual-barrel cartridge," 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 to "reproduce the structure of a patient's teeth and gums" for dental procedures like crowns, bridges, and implants. This is a physical impression of anatomical structures, not a test performed on biological samples to diagnose a condition or provide information about a physiological state.
- Device Description: It's a dental impression material, a physical substance used to create a mold.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The performance metrics listed (Consistency, Working time, Detail reproduction, etc.) are related to the physical properties and performance of the impression material itself, not its ability to diagnose or provide information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (on the body) to create a physical replica.
N/A
Intended Use / Indications for Use
VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
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 a two-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
patient's teeth and gums
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.)
Consistency: 31
Working time: 2'
Detail reproduction: complies
Linear dimensional change: 0.16%
Compatibility with gypsum: complies
Elastic recovery: 99.06%
Strain-in-compression: 2.73%
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.
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 shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
September 4, 2019
Hygedent Inc. Peng Wang General Manager Room 210C, Building 4, No 5 Chaoqian Road, Science Industry Park, Changping Beijing, 102299 Cn
Re: K191034
Trade/Device Name: VPS Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: March 20, 2019 Received: April 18, 2019
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.
1
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 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 (QS) 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 medical devices and radiation-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.
for Michael Adjodha Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191034
Device Name VPS Impression Marterial
Indications for Use (Describe)
VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.
| 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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3
Chapter 6 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 03/20/2019 | |||
|---|---|---|---|---|
| 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: | 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: | VPS 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: |
| K040053: Discus Dental, Inc. | |
| Precision VPS Impression Material | |
| Reference Predicate Device: | |
| K133071: Shandong Huge Dental Material Corporation | |
| Elastomeric Impression Material | |
| Device Description: | 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 a two-part base/catalyst | |
| formulation preloaded in a dual-barrel cartridge. The VPS | |
| Impression Material package includes four dual-barrel 50ml | |
| cartridges. | |
| Comparison of | |
| Indications for Use: | VPS Impression Material is intended for use with all crowns, bridges, |
| occlusal and dental implant impression techniques to reproduce the | |
| structure of a patient's teeth and gums. |
K040053: Precision VPS Impression Material is intended for use
with all crowns, bridges, occlusal and dental implant impression
techniques to reproduce the structure of a patient's teeth and gums.
K133071: A Silicone Dentistry-Elnstie Impression Material, with
the trade name of PERFIT. is an addition-cure vinyl polysiloxane
dental impression material that is used far all crown and bridge,
edentulous, orthodontic and implant impression techniques. |
5
Indications for Use
Discussion: _ VPS Impression Material Is comparable to other vinyl Polysiloxane dental impression materials on the market, such as Precision VPS Impression Material (K040053) and Elastomeric Impression Material (K133071).the devices have the same intended use and except for minor differences in composition to achieve certain features such as rapid setting or elasticity, Strain-in-compression employ the same vinyl Polysiloxane chemistry. All three products may be employed in the same clinical applications. The difference between VPS Impression Material and the declared predicate devices lie in the selection and relative percentages of the additives, all of which are common for vinyl Polysiloxane impression materials.
Technology
- The technology for the proposed device VPS Impression Material is characteristics: comparable to the predicate device.VPS Impression Material is mainly composed of Vi-PDMS, Hydrogen-containing Silicone Oil, Catalyst, Inhibitor, Silica Powder and Filler. Vi-PDMS is used as the base polymer, Hydrogen-containing Silicone Oil as a crosslinking agent, Pt Catalyst as catalysts, Silica Fume is used as filler, Fumed Silica can be used as a filler for reinforcements. Besides, Inhibitor, Thinner, Pigments are added.
Technological
characteristics
Discussion: Proposed device and Primary Predicate Device (K040053), have the same raw materials,except for minor differences in proportion. This difference does not affect the safety and effectiveness.
Page 6-3
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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 | Standard
ISO4823 |
|---------------------------------|-------------------------------|-----------------------------------------|----------------------------------------------------|---------------------|
| | K191034 | K040053 | K133071 | |
| | | | Shandong
Huge Dental
Material
Corporation | |
| | Hygedent
Inc. | Discus
Dental,Inc. | | |
| | VPS
Impression
Material | Precision VPS
Impression
Material | Elastomeric
Impression
Material | |
| Consistency | 31 | 32 | 31 | ≤35mm |
| Working time | 2' | 1'45" | 2' | ≥1'30" |
| Detail
reproduction | complies | complies | complies | 50μm |
| Linear
dimensional
change | 0.16% | 0.18% | 0.20% | ≤1.5% |
| Compatibility
with gypsum | complies | complies | complies | 50μm |
| Elastic
recovery | 99.06% | 99.0% | 98.98% | ≥96.5% |
| Strain-in-
compression | 2.73% | 2.38% | 3.12% | >0.8%