(120 days)
Not Found
No
The 510(k) summary describes a dental impression material, which is a physical substance used to create molds. There is no mention of software, algorithms, or any computational processing that would involve AI or ML.
No.
The material is used to reproduce the structure of teeth and gums for impression taking, which is a diagnostic rather than therapeutic purpose.
No
Explanation: This device is an impression material used to reproduce the structure of teeth and gums, not to diagnose a medical condition. Its purpose is to create a physical model, not to provide diagnostic information about disease.
No
The device description clearly states it is a "polyvinylsiloxane dental impression material," which is a physical substance, 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 impression techniques. This is a physical process for creating a mold, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description confirms it's a dental impression material used to create a physical impression.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVDs are typically used to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and related to creating a physical representation of anatomical structures.
N/A
Intended Use / Indications for Use
DentMix VPS Impression Material is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.
Product codes
ELW
Device Description
DentMix VPS Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.
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
Prescription Use
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)
Comparison of Testing:
Test Method: Mixing Time, Consistency, Working Time (Regular Set), Working Time (Fast Set), Detail Reproduction, Linear Dimensional Change, Compatibility with Gypsum, Elastic Recovery, Strain-In-Compression.
Results for Dentimix VPS Impression Material (K223892) vs. Elements TM (K151150) for Heavy Body, Monophase, and Light Body variations were presented.
The conclusion states: "Dentimix VPS Impression Material is substantially equivalent to the predicate device Elements TM (K151150) in terms of physical properties."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Consistency:
Heavy Body: 32mm (Dentimix) vs 31mm (Elements TM)
Monophase: 35mm (Dentimix) vs 35mm (Elements TM)
Light Body: 40mm (Dentimix) vs 39mm (Elements TM)
Working Time (Regular Set):
Heavy Body: 2'34" (Dentimix) vs 2'30" (Elements TM)
Monophase: 2'12" (Dentimix) vs 2'30" (Elements TM)
Light Body: 2'37" (Dentimix) vs 2'30" (Elements TM)
Working Time (Fast Set):
Heavy Body: 1'16" (Dentimix) vs 1'30" (Elements TM)
Monophase: 1'23" (Dentimix) vs 1'30" (Elements TM)
Light Body: 1'21" (Dentimix) vs 1'30" (Elements TM)
Detail Reproduction: PASS for all Dentimix and Elements TM variations.
Linear Dimensional Change:
Heavy Body: 0.14% (0.01) (Dentimix) vs 0.14% (0.01) (Elements TM)
Monophase: 0.05% (0.02) (Dentimix) vs 0.05% (0.02) (Elements TM)
Light Body: 0.08% (0.02) (Dentimix) vs 0.08% (0.02) (Elements TM)
Compatibility with Gypsum: PASS for all Dentimix and Elements TM variations.
Elastic Recovery:
Heavy Body: 99.1 (.2) (Dentimix) vs 99.7 (0.1) (Elements TM)
Monophase: 99.1 (.3) (Dentimix) vs 99.6 (0.3) (Elements TM)
Light Body: 98.9 (.1) (Dentimix) vs 99.8 (0.1) (Elements TM)
Strain-In-Compression:
Heavy Body: 2.54 (.8) (Dentimix) vs 2.85 (0.1) (Elements TM)
Monophase: 3.61 (.4) (Dentimix) vs 3.67 (0.13) (Elements TM)
Light Body: 5.91 (1.6) (Dentimix) vs 4.93 (0.1) (Elements TM)
Predicate Device(s)
Elements TM (K151150)
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).
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April 27, 2023
Innovative Product Brands, Inc. Shane Nielsen Chief Executive Officer 7045 Palm Avenue Highland, California 92346
Re: K223892
Trade/Device Name: DentMix VPS Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: February 7, 2023 Received: February 7, 2023
Dear Shane Nielsen:
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
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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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223892
Device Name DentMix VPS Impression Material
Indications for Use (Describe)
DentMix VPS Impression Material is intended for use with all crown and bridge, occlusal and 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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Image /page/3/Picture/0 description: The image shows the logo for IPB Inc. The letters IPB are in a large, bold, blue font. Below the letters IPB, the words "Innovative Product Brands" are written in a smaller, black font. The word "Inc" is in a smaller, black font and is located to the right of the letters IPB.
K223892 510(k) Summary
Submitter:
IPB Inc 7045 Palm Avenue Highland, CA 92346
Contact Person:
Shane Nielsen President / CEO 909-864-7477
Date Summary Prepared:
(Revised per FDA request) April 2023
Device Name Trade Name: DentMix VPS Impression Material Common Name: Dental Impression Material Device Classification: Class II Classification Product Code: ELW Classification Name: Material, Impression, per 21 CFR 872.3660
Predicate Device
ElementsTM
Description of Device
DentMix VPS Impression Material is an addition-reaction base/catalyst polyviny/siloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.
Indications for Use
DentMix VPS Impression Material is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.
7045 Palm Ave, Highland, CA 92346 ● (909) 864-7477 ● Fax (909) 864-7232 www.ipbinc.com
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| Descriptive
Information | Subject Device
DentMix VPS Impression
Material (K223892) | Predicate Device
Elements™ (K151150) | Summary |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | DentMix VPS Impression
Material is intended for use
with all crown and bridge,
occlusal and implant
impression techniques to
reproduce the structure of a
patient's teeth and gums. | Elements™ is intended for use
with all crown and bridge,
occlusal and implant impression
techniques to reproduce the
structure of a patient's teeth and
gums. | The indications for use
of the subject and
predicate devices are
intended for use with
all crown and bridge,
occlusal and implant
impression techniques
to reproduce the
structure of a patient's
teeth and gums. |
| Composition of
Materials | Vinyl Polysiloxane
Filler
Pigments | Vinyl Polysiloxane
Filler
Pigments | The composition of the
subjective and
predicate devices
are the same. |
| Mode of Use | 1. Light body (Type 3)
A low viscosity impression
material used to capture
extraordinary subgingival
details.
2. Regular body/Monophase
(Type 2)
A medium viscosity monophase
impression
material used in single step
impression procedures.
3. Heavy body (Type 1)
A heavy body impression
material used as base in
two-step heavy-wash
applications. | 1. Light body (Type 3)
A low viscosity impression
material used to capture
extraordinary subgingival
details.
2. Regular body/Monophase
(Type 2)
A medium viscosity monophase
impression
material used in single step
impression procedures.
3. Heavy body (Type 1)
A heavy body impression
material used as base in
two-step heavy-wash
applications. | The mode of use of the
subjective and
predicate devices
are the same. |
| FDA-Recognized
Standards | ISO 4823-2015 | ISO 4823-2015 | Claims are the same |
Comparison of Technological Characteristics
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Image /page/5/Picture/0 description: The image contains the logo for IPB Inc. The letters "IPB" are in a large, bold, blue font. Below the letters, the words "Innovative Product Brands" are written in a smaller, black font. To the right of the letters, the word "Inc" is written in a smaller, black font.
| Test Method | Dentimix VPS Impression Material
(K223892) | | | Elements TM ( K151150) | | |
|-------------------------------|-----------------------------------------------|--------------|-----------------|------------------------|--------------|-----------------|
| | Heavy
Body | Monophase | Light
Body | Heavy
Body | Monophase | Light
Body |
| Mixing Time | N/A | N/A | N/A | N/A | N/A | N/A |
| Consistency | 32mm | 35mm | 40mm | 31mm | 35mm | 39mm |
| Working Time
(Regular Set) | 2'34" | 2'12" | 2'37" | 2'30" | 2'30" | 2'30" |
| Working Time (Fast
Set) | 1'16" | 1'23" | 1'21" | 1'30" | 1'30" | 1'30" |
| Detail Reproduction | PASS | PASS | PASS | PASS | PASS | PASS |
| Linear Dimensional
Change | 0.14%
(0.01) | 0.05% (0.02) | 0.08%
(0.02) | 0.14%
(0.01) | 0.05% (0.02) | 0.08%
(0.02) |
| Compatibility with
Gypsum | PASS | PASS | PASS | PASS | PASS | PASS |
| Elastic Recovery | 99.1 (.2) | 99.1 (.3) | 98.9 (.1) | 99.7 (0.1) | 99.6 (0.3) | 99.8 (0.1) |
| Strain-In-
Compression | 2.54 (.8) | 3.61 (.4) | 5.91 (1.6) | 2.85 (0.1) | 3.67 (0.13) | 4.93 (0.1) |
Comparison of Testing
Conclusion:
Dentimix VPS Impression Material is substantially equivalent to the predicate device Elements TM (K151150) in terms of physical properties.