(59 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the impression material, with no mention of AI or ML.
No
The device is described as a silicone impression material used for creating impressions of oral tissues, which is a diagnostic or procedural tool, not a therapeutic treatment.
No
The device description indicates silicone impression materials used for creating impressions of oral tissues, such as for crowns, bridges, inlays, onlays, and dentures. These impressions are used to fabricate dental prosthetics, which is a restorative rather than a diagnostic function.
No
The device description clearly states it is a family of silicone impression materials, which are physical substances used to create molds. This is a hardware-based medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The DENU family of silicone impression materials is used to create physical impressions of oral tissues (crowns, bridges, inlays, onlays, dentures, models). This is a physical process for creating a mold, not a test performed on a biological sample to diagnose or monitor a condition.
- Intended Use: The intended uses listed are all related to creating physical impressions for dental restorations and models. None of them involve analyzing a biological sample for diagnostic purposes.
Therefore, based on the provided information, the DENU Light Body, Heavy Body, and Putty Set are dental impression materials and do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
- Denture impression
- Model impression
DENU Putty Set(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use. Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices.
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)
Non-clinical testing was performed based on referenced standards. All test results met preset criteria.
- ISO 4823: Appearance and Component colors, Consistency, Working time, Detail reproduction, Setting time, Compatibility with gypsum, Linear dimensional change, Elastic recovery, Strain in compression
- ISO 7405: Cytotoxicity
- ISO 10993-10: Skin sensitization, Oral mucosa irritation
- ISO 10993-11: Acute systemic toxicity
Key results of performance characteristics (Working time, Setting reaction time, Consistency, Compatibility with gypsum, Strain in compression, Dimensional accuracy, mixing time) were compared between the subject devices and predicate devices, showing equivalence, better performance, or conformance to relevant ISO standards.
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.
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.
November 7, 2022
HDI, Inc. Taekyou Kim CEO A-1504, 14, Sagimakgol-ro, 45 Beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-do 13209 SOUTH KOREA
Re: K222741
Trade/Device Name: DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: August 25, 2022 Received: September 9, 2022
Dear Taekyou Kim:
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.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K222741
Device Name DENU Light Body(Regular, Fast) DENU Heavy Body(Regular, Fast) DENU Putty Set(Regular, Fast)
Indications for Use (Describe) DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
- Denture impression
- Model impression
DENU Putty Set(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
| 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
K222741
006_ 510(k) SUMMARY
Date: August 25, 2022
1. SUBMITTER
HDI, Inc.
A-1504, 14, Sagimakgol-ro, 45 Beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do,
Republic of Korea
TEL : +82-31-735-3510
FAX : +82-31-735-3511
Contact Name: Taekyou Kim
Email: hdikorea@hanmail.net
2. DEVICE
·Trade Name: DENU Light Body(Regular, Fast) DENU Heavy Body(Regular, Fast) DENU Putty Set(Regular, Fast)
·Common Name: Impression Material
· Regulation Number 872.3660
·Class: 2
·Classification Product Code: ELW
3. PREDICATE DEVICE
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast) : K152615 Vonflex STM, Vericom Co. Ltd DENU Putty Set(Regular, Fast) Vonflex S Putty, Vericom Co. Ltd : K152518
4. DEVICE DESCRIPTION
The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further
4
classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use.
Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices.
5. INDICATIONS FOR USE
DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
- Denture impression
- Model impression
DENU Putty Set(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
6. NON-CLINICAL TESTING
The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.
- ISO 4823 Appearance and Component colors, Consistency, Working time, Detail reproduction, Setting time, Compatibility with gypsum, Linear dimensional change, Elastic recovery, Strain in compression
- ISO 7405 Cytotoxicity •
- ISO 10993-10 - Skin sensitization, Oral mucosa irritation
- ISO 10993-11 Acute systemic toxicity •
7. SUBSTANITAL EQUIVALENCE
| | Subject device | Predicate Device | Discuss/Justify the
Differences |
|---------------|----------------|------------------|------------------------------------|
| 510(k) Number | New | K152615 | - |
5
| Trade Name | DENU Light Body(Regular, Fast)
DENU Heavy Body(Regular, Fast) | Vonflex STM | - | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | HDI, Inc. | Vericom Co. Ltd | - | |
| Common Name | Impression material | Impression material | Same | |
| Device Class | 2 | 2 | Same | |
| Product Code | ELW | ELW | Same | |
| Device Description | The DENU family of silicone
impression materials consists
of three different viscosities
(light body, heavy body, putty)
for various application systems.
Products are further classified
into Regular type and Fast
type, depending on curing time,
but there is no difference on
viscosity, indications for use,
or scope of use.
Each device is consisted of 1:1
base and catalyst component,
packaged in 560mL jars for
DENU Putty set and 50mL
syringes for other devices. | Vonflex STM, as the additional
polymerization silicone type, is
composed of a two component
(base and catalyst, mixing ratio
1:1) hydrophilic vinyl
polysiloxane impression
material for all dental
impression techniques. Vonflex
STM consists of light-bodied,
medium-bodied or heavy-
bodied consistencies in
delivery systems of cartridges
and/or tubes. It has normal set
and fast set that would be
desired by the operator. | Same | |
| Indications for use | • Crown and bridge impression
• Inlay and onlay impression
• Denture impression
• Model impression | • Impression material in dual
phase impression technique
• Precise duplication of models
• Capturing multiple unit
impressions
• Impression of inlay, crown,
bridge and partial denture etc. | Same
The subject and
predicate device have
the same intended
use. Both devices are
used for dental
impression
techniques according
to their consistencies. | |
| Physical State | Two product lines (DENU
Light Body, DENU heavy
Body) are provided with | Various pastes with various
viscosity | Similar
Both subject and
predicate devices are | |
| | | different viscosity. | | provided as putties
with various
elasticities.
The physical states
are similar, as
compared in physical
properties. |
| Structure | | Addition type silicone based
elastomeric impression
materials | Addition type silicone based
elastomeric impression
materials | Same |
| | Packaging | Primary packaging : Cartridges
Secondary packaging :
Fiberboard | Primary packaging : Cartridges
Secondary packaging :
Fiberboard | Same |
| Usage | | Single patient, single use.
Not reusable | Single patient, single use.
Not reusable | Same |
| | Sterility | Non-sterile | Non-sterile | Same |
| Handling System | | Two part base/catalyst system | Two part base/catalyst system | Same |
| Type of Curing | | Self-curing after mixing of base
and catalyst part. | Self-curing after mixing of base
and catalyst part. | Same |
| Physical
properties | Light
body,
regular | See the table below | See the table below | Similar |
| | Light
body, fast | See the table below | See the table below | Individual values of
physical properties
are same or similar.
Every physical
property of predicate
and subject device |
| | Heavy
body,
regular | See the table below | See the table below | |
| | Heavy
body, fast | See the table below | See the table below | conforms to the
related standard. |
| | Chemical
composition | Vinyl siloxanes | Vinyl siloxanes | Similar |
| | | Vinyl terminated
cyclosiloxanes | | Both device are
composed of vinyl
terminated siloxane,
cross-linking |
| | | Siloxane and Silicone, di-Me,
Me Hydrogen | Hydrogen polysiloxane | |
| | | Silica | Silica | siloxane, Filler |
| | Silicon dioxide | Fumed silica | platinum catalyst
pigments and
surfactant. | |
| | Pt-divinyltetramethyldisiloxane
in Polysiloxane | Organo platinum complex | | |
| | Pigments | Pigments | | |
| | surfactant | Surfactant | | |
| Biocompatibility | Meets ISO 10993-1 for a
surface device contacting
mucosal membrane and dentin
for a short-term contact
duration (>24h) | Conforms with ISO 10993-1 | Same | |
| Standards
conformed | ISO 4823
ISO 10993-1 | ISO 4823
ISO 10993-1 | Same | |
6
7
| | DENU Light Body(Regular, Fast) | Vonflex | Standard | Discuss/Justify
the Differences | |
|------------------------------|--------------------------------|---------------------------|---------------------------|-------------------------------------------|------------|
| | DENU Heavy Body(Regular, Fast) | STM | Predicate
device | | |
| | Subject device | | | | |
| Working time | Light body, regular | 1'30" | 2'30" | [ISO 4823:2021
7.3] | Equivalent |
| | Light body, fast | 1'30" | 1'30" | suggested value
of the
manufacturer | Equivalent |
| | Heavy body, regular | 1'30" | 2'15" | | Equivalent |
| | Heavy body, fast | 1'30" | 1'30" | | Equivalent |
| Setting reaction time | Light body, regular | 4'10" | 4'00" | [ISO 4823:2021
7.3] | Equivalent |
| | Light body, fast | 2'40" | 2'30" | suggested value
of the
manufacturer | Equivalent |
| | Heavy body, regular | 4'10" | 4'00" | | Equivalent |
| | Heavy body, fast | 2'40" | 2'30" | | Equivalent |
| Consistency | Light body, regular | 39.18 mm | 43.43 mm | [ISO 4823:2021
7.2] | Equivalent |
| | Light body, fast | 36.16 mm | 42.02 mm | >= 36 mm | Equivalent |
| | Heavy body, regular | 34.10 mm | 34.76 mm | [ISO 4823:2021
7.2] | Equivalent |
| | Heavy body, fast | 32.54 mm | 34.78 mm | 24h) | Conforms with ISO 10993-1 | Same |
| Standards
conformed | ISO 4823
ISO 10993-1 | ISO 4823
ISO 10993-1 | Same |
| | DENU Putty Set Regular | Vonflex STM | Standard | Discuss/Justif
y the
Differences | |
|-------------------------|------------------------|------------------|----------|----------------------------------------|------------------------------------------------|
| DENU Putty Set Fast | | | | | |
| | Subject device | Predicate device | | | |
| Dimensional
accuracy | Putty Set Regular | 0.21% |