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.

Device Description

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.

AI/ML Overview

The provided document describes the substantial equivalence determination for the "DentMix VPS Impression Material" (K223892) by comparing it to a predicate device, "Elements™" (K151150). The acceptance criteria are based on meeting or exceeding the performance of the predicate device across various physical properties, typically measured against recognized standards like ISO 4823-2015.

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

A direct table of "acceptance criteria" is not explicitly stated as distinct from the predicate device's performance. Instead, the study aims to show that the subject device performs at least as well as the predicate device. Therefore, the predicate device's performance serves as the de facto acceptance benchmark.

Acceptance Criteria (Predicate Performance)	Reported Device Performance (DentMix VPS Impression Material)
Consistency
Heavy Body: 31mm	Heavy Body: 32mm
Monophase: 35mm	Monophase: 35mm
Light Body: 39mm	Light Body: 40mm
Working Time (Regular Set)
Heavy Body: 2'30"	Heavy Body: 2'34"
Monophase: 2'30"	Monophase: 2'12"
Light Body: 2'30"	Light Body: 2'37"
Working Time (Fast Set)
Heavy Body: 1'30"	Heavy Body: 1'16"
Monophase: 1'30"	Monophase: 1'23"
Light Body: 1'30"	Light Body: 1'21"
Detail Reproduction	PASS
Linear Dimensional Change
Heavy Body: 0.14% (0.01)	Heavy Body: 0.14% (0.01)
Monophase: 0.05% (0.02)	Monophase: 0.05% (0.02)
Light Body: 0.08% (0.02)	Light Body: 0.08% (0.02)
Compatibility with Gypsum	PASS
Elastic Recovery
Heavy Body: 99.7 (0.1)	Heavy Body: 99.1 (0.2)
Monophase: 99.6 (0.3)	Monophase: 99.1 (0.3)
Light Body: 99.8 (0.1)	Light Body: 98.9 (0.1)
Strain-In-Compression
Heavy Body: 2.85 (0.1)	Heavy Body: 2.54 (0.8)
Monophase: 3.67 (0.13)	Monophase: 3.61 (0.4)
Light Body: 4.93 (0.1)	Light Body: 5.91 (1.6)

Note on "Acceptance Criteria": For each of these properties, the acceptance criterion implicitly is that the DentMix VPS Impression Material is functionally equivalent to or performs within an acceptable range compared to the predicate device, often guided by the ISO 4823-2015 standard. "PASS" explicitly indicates meeting a standard. For numerical values, the goal is typically to be similar or better.

Study Details for DentMix VPS Impression Material

The document outlines a comparison study to demonstrate substantial equivalence, primarily focusing on physical properties.

Sample size used for the test set and the data provenance:
- The document does not explicitly state the numerical "sample size" for each test point (e.g., number of specimens tested for consistency, working time, etc.). However, the values reported for "Linear Dimensional Change," "Elastic Recovery," and "Strain-In-Compression" include standard deviations (e.g., "0.14% (0.01)"), which implies that multiple measurements were taken to calculate an average and variability.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It presents the results as part of a 510(k) submission by IPB Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of detail (number and qualifications of experts) is typically associated with clinical studies or studies where human interpretation or consensus is required (e.g., image analysis). For material property testing as performed here, the "ground truth" is established by direct measurement of physical properties according to standardized test methods (e.g., those described in ISO 4823-2015). Experts in material science or dentistry might design and oversee these tests, but their "consensus" is not the ground truth in the same way it would be for diagnosing a medical image.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication methods (e.g., 2+1) are relevant for studies involving human interpretation and potential disagreement (e.g., reading medical images). For physical property testing of dental impression materials, direct measurements are taken, and typically, there is no "adjudication" in this sense. Quality control and adherence to standard protocols ensure reliability.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for evaluating a dental impression material, as it's a diagnostic tool comparison for medical imaging interpretation, not a material property evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is also not applicable. The device is a physical dental impression material, not an algorithm or AI system. The performance evaluated is the inherent physical properties of the material itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation in this context is the results of standardized physical property tests as defined by recognized standards (specifically ISO 4823-2015). This is a direct measurement of material characteristics against objective criteria, not based on human consensus, pathology, or outcomes data.
The sample size for the training set:
- This concept is not applicable. The evaluation is a direct comparison of physical material properties against a predicate, not a machine learning model that requires a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device evaluation.

Summary

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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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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

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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DescriptiveInformation	Subject DeviceDentMix VPS ImpressionMaterial (K223892)	Predicate DeviceElements™ (K151150)	Summary
Indications forUse	DentMix VPS ImpressionMaterial is intended for usewith all crown and bridge,occlusal and implantimpression techniques toreproduce the structure of apatient's teeth and gums.	Elements™ is intended for usewith all crown and bridge,occlusal and implant impressiontechniques to reproduce thestructure of a patient's teeth andgums.	The indications for useof the subject andpredicate devices areintended for use withall crown and bridge,occlusal and implantimpression techniquesto reproduce thestructure of a patient'steeth and gums.
Composition ofMaterials	Vinyl PolysiloxaneFillerPigments	Vinyl PolysiloxaneFillerPigments	The composition of thesubjective andpredicate devicesare the same.
Mode of Use	1. Light body (Type 3)A low viscosity impressionmaterial used to captureextraordinary subgingivaldetails.2. Regular body/Monophase(Type 2)A medium viscosity monophaseimpressionmaterial used in single stepimpression procedures.3. Heavy body (Type 1)A heavy body impressionmaterial used as base intwo-step heavy-washapplications.	1. Light body (Type 3)A low viscosity impressionmaterial used to captureextraordinary subgingivaldetails.2. Regular body/Monophase(Type 2)A medium viscosity monophaseimpressionmaterial used in single stepimpression procedures.3. Heavy body (Type 1)A heavy body impressionmaterial used as base intwo-step heavy-washapplications.	The mode of use of thesubjective andpredicate devicesare the same.
FDA-RecognizedStandards	ISO 4823-2015	ISO 4823-2015	Claims are the same

Comparison of Technological Characteristics

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Test Method	Dentimix VPS Impression Material(K223892)			Elements TM ( K151150)
	HeavyBody	Monophase	LightBody	HeavyBody	Monophase	LightBody
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 (FastSet)	1'16"	1'23"	1'21"	1'30"	1'30"	1'30"
Detail Reproduction	PASS	PASS	PASS	PASS	PASS	PASS
Linear DimensionalChange	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 withGypsum	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.

Regulation Number and Section

§ 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).