(94 days)
No
The device description and performance studies focus on the physical and biocompatibility properties of a silicone material, with no mention of AI or ML technologies.
No
This device is for making occlusal registrations in dentistry, which is a diagnostic or procedural aid, not a therapeutic intervention that treats or prevents a disease.
No
Explanation: The device is used for making occlusal registrations, which are impressions of the bite, not for diagnosing medical conditions. It aids in dental procedures by accurately recording the bite during surgery and in the laboratory.
No
The device description clearly states it is a physical material (vinylpolysiloxane) used for bite registration, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "making occlusal registrations." This is a mechanical process used in dentistry to record the relationship between the upper and lower teeth. It does not involve testing a sample from the human body to provide information about a physiological state, disease, or condition.
- Device Description: The device is a silicone material used for physical impression taking. Its components are materials used for their physical properties (flexibility, setting time, etc.) to create a mold.
- Lack of IVD Characteristics: The description 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 (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
The device is clearly a dental material used for a physical procedure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
A-Silicone for Bite Registration is indicated for making occlusal registrations.
Product codes
ELW
Device Description
A-Silicone for Bite Registration is a vinylpolysiloxane (addition silicone), also known as A-Silicones, polyvinyl siloxanes (PVS), or vinyl polysiloxanes (VPS), especially made for bite registration work in the surgery and laboratory. It mainly contains polydimethylsiloxane, silica and platinum catalyst.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Physical properties testing: A-Silicone for Bite Registration was tested and met the applicable requirements of the FDA Recognized Consensus standard: ISO 4823 Fourth edition 2015-08-01 Dentistry -Elastometric impression materials. Key results: Component colours: Satisfactory, Consistency: Satisfactory, Linear dimensional change: Satisfactory, Detail reproduction: Satisfactory, Elastic recovery: Satisfactory.
Biocompatibility testing: Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity, Sensitization and Irritation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 24, 2020
Maggie Zheng, Regulatory Affairs Manager Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District Rizhao City. CHINA 276800 Shandong Province
Re: K201684
Trade/Device Name: A-Silicone for Bite Registration Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: June 15, 2020 Received: June 22, 2020
Dear Maggie Zheng:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 Srinvas "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 Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201684
Device Name A-Silicone for Bite Registration
Indications for Use (Describe) A-Silicone for Bite Registration is indicated for making occlusal registrations.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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the
3
K201684
510 (k) Summary
This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.
-
- Date Summary Prepared: September 24, 2020
-
- Submitter Information:
| Name | Shandong Huge Dental Material Corporation |
|---|---|
| Address | No. 68 Shanhai Road, Donggang District, Rizhao City |
| Shandong Province, 276800, P.R. China | |
| Telephone | 086-633-2277285 |
| Fax | 086-633-2277298 |
| Contact Person | Mrs. Maggie Zheng |
| Contact Title | Regulatory Affairs Manager |
| zhengxy@hugedent.com |
3. Device Name
Trade name: A-Silicone for Bite Registration
Common name: Bite Registration
Classification name: Impression material (21 CFR 872.3660)
Regulatory Class: II
Product Code: ELW
4. Predicate Device Information
| Table 1: Predicate Device Information | ||||
|---|---|---|---|---|
| Owner/Operator | Device Trade Name | 510 (k) No. | Product Code | Predicate |
| Zhermack S. P. A. | Occlufast Rock | K024034 | ELW | Primary |
This predicate have not been subject to a design-related recall.
No reference devices were used in this submission.
5. Description of Device
4
HUGE
A-Silicone for Bite Registration is a vinylpolysiloxane (addition silicone), also known as A-Silicones, polyvinyl siloxanes (PVS), or vinyl polysiloxanes (VPS), especially made for bite registration work in the surgery and laboratory. It mainly contains polydimethylsiloxane, silica and platinum catalyst.
6. Indications for Use
A-Silicone for Bite Registration is indicated for making occlusal registrations.
7. Technological Characteristics
All components of the A-Silicone for Bite Registration are based upon industry well-known chemistry. A-Silicone for Bite Registration is vinylpolysiloxane based materials which has two components addition-type (platinum-catalyzed) silicone rubber. If two parts were mixed together, it will transform into elastomeric materials by the platinum-catalyzed addition curing reaction. The following table shows the technological characteristics for the subject device and indicates the following similarities and differences with the predicate device:
| Table 4: Technological Characteristics Comparison Table | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Technological | ||||||||||||||||||
| Characteristics | Subject device | |||||||||||||||||
| (A-Silicone for Bite Registration) | Primary predicate device | |||||||||||||||||
| (Occlufast Rock, K024034) | ||||||||||||||||||
| Description | ||||||||||||||||||
| of Material | Vinylpolysiloxane based | Vinylpolysiloxane based | ||||||||||||||||
| Mode of Action | Addition-curing bite registration | Addition-curing bite registration | ||||||||||||||||
| Indications of Use | A-Silicone for Bite Registration is | |||||||||||||||||
| indicated for making occlusal | ||||||||||||||||||
| registrations. | Zhermack OCCLUFAST ROCK a dental | |||||||||||||||||
| impression material intended to be | ||||||||||||||||||
| placed on a preformed impression tray and | ||||||||||||||||||
| used to reproduce the structure of | ||||||||||||||||||
| a patient's teeth and gums. | ||||||||||||||||||
| Prescription/over- | ||||||||||||||||||
| the-counter use | Prescription | Prescription | ||||||||||||||||
| Physical Form | Double cartridge system 1:1 | Double cartridge system 1:1 | ||||||||||||||||
| Accessories | Mixing tips, Dispenser | Mixing tips, Dispenser | ||||||||||||||||
| Physical Properties | HUGE ZHERMACK Remarks Trade name A Silicone For | |||||||||||||||||
| Bite Registration Occlufast Rock / Consistency | ||||||||||||||||||
| (≤35mm) 20mm 23mm Similar Linear dimensional | ||||||||||||||||||
| change | ||||||||||||||||||
| ( |