(126 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a dental impression material, with no mention of AI or ML.
No
The device is an impression material used for diagnostic or planning purposes in dentistry, not for treating a disease or condition.
No
The device is described as an "Impression Material" used for taking dental impressions in crown, bridge, and orthodontic techniques, which is a material used for creating molds, not for diagnosing conditions.
No
The device description clearly states it is an "Impression Material" composed of physical substances like vinyl polysiloxane and various fillers, which are hardware components, 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 "Used for all crown, bridge, and orthodontic impression techniques." This describes a device used to create a physical mold of teeth and surrounding structures for dental procedures. This is a mechanical process, not a diagnostic test performed on biological samples.
- Device Description: The description details the chemical composition of an impression material used to create a physical impression. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is clearly intended for use in dental procedures to create physical impressions, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Used for all crown, bridge, and orthodontic impression techniques.
Product codes
ELW
Device Description
The Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry.
It consists of base and catalyst, in which putty base contains Vinyl polysiloxane, Methylhydrogensiloxane dimethylsiloxane, dimeticone, white oil and silicon.
Catalyst mainly contains vinyl polysiloxane, platinum catalyst, dimeticone, white oil and silicon. The product is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A ISO 10993-11 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
- A ISO 4823 Dentistry - Elastomeric impression materials
No clinical study is included in this submission.
Key Metrics
Consistency: 32 mm (= 96.5% Accepted)
Strain in compression %: 4.52 (0.8 ~ 20% Accepted)
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
October 8, 2020
Zhengzhou Huaer Electro Optics Technology Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA
Re: K201483
Trade/Device Name: Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: September 8, 2020 Received: September 11, 2020
Dear Ivy 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 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.
for Srinivas "Nandu" Nandkumar, Ph.D. 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
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Indications for Use
510(k) Number (if known) K201483
Device Name Impression Material
Indications for Use (Describe) |
---|
Used for all crown, bridge, and orthodontic impression techniques. |
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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K201483
510(K) Summary
Date of Summary prepared: 2020-10-02
A. Applicant:
Zhengzhou Huaer Electro Optics Technology Co., Ltd Address: Floor 11, B of Building 18, the National University Science Park of Henan Province, Zhengzhou city, China, 450000 Contact Person: Li XiaoJun Tel: +86 13592524674 Mail: admin@cnhuaer.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Impression Material Common Name: Dental Impression Material
Regulatory Information Classification Name: Material, Impression Classification: Class II. Product code: ELW Regulation Number: 872.3660 Review Panel: Dental
C. Predicate device:
K152518 Vonflex S™ Putty VERICOM Co., Ltd.
D. Intended use of the device:
Used for all crown, bridge, and orthodontic impression techniques.
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K201483
E. Device Description:
The Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry.
It consists of base and catalyst, in which putty base contains Vinyl polysiloxane, Methylhydrogensiloxane dimethylsiloxane, dimeticone, white oil and silicon.
Catalyst mainly contains vinyl polysiloxane, platinum catalyst, dimeticone, white oil and silicon. The product is provided non-sterile.
F. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A ISO 10993-11 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
- A ISO 4823 Dentistry - Elastomeric impression materials
G. Clinical Test Conclusion
No clinical study is included in this submission.
H. Comparison with predicate device
Table 1 Comparison Table
Device | Proposed Device | Predicate Device | Result |
---|---|---|---|
Manufacturer | Zhengzhou Huaer Electro | ||
Optics Technology Co., Ltd | VERICOM Co., Ltd. | - | |
510K number | K201483 | K152518 | - |
Model Name | Impression Material | Vonflex S™ Putty | - |
Classification | Class II Device, ELW (21 CFR | ||
872.3660) | Class II Device, ELW (21 CFR | ||
872.3660) | Same | ||
Intend use | Used for all crown, bridge, | ||
and orthodontic | |||
impression techniques. | It is used for all crown, bridge | ||
and orthodontic impression | |||
techniques. | Same | ||
Standard conformed | ISO4823 | ISO4823 | Same |
Physical properties | - Classification according to | ||
ISO4823: Type 0 |
- Dimensional accuracy:
Max.1.5% - Consistency: Max. 35mm
- Compatibility with the die and
cast materials: 75 μm | - Classification according to
ISO4823: Type 0 - Dimensional accuracy:
Max.1.5% - Consistency: Max. 35mm
- Compatibility with the die and
cast materials: 75 μm | Same |
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K201483
| | reproduction
- Curve of the shrinkage (Strain
in compression): Min.0.8 ~
Max.20% | reproduction - Curve of the shrinkage (Strain
in compression): Min.0.8 ~
Max.20% | |
|------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------|
| Raw Material | Vinyl polysiloxane | Vinyl polysiloxane | Same |
| Mixing Ratio | 1:1 | 1:1 | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Method of Manipulation | Hand-kneaded mixes | Hand-kneaded mixes | Same |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
Table 2 Performance parameter
Item | Proposed device | Acceptance Criteria (Type 0) | Result |
---|---|---|---|
Consistency | 32 mm |