DentMix VPS Impression Material

K223892 · Innovative Product Brands, Inc. · ELW · Apr 27, 2023 · Dental

Device Facts

• Record ID: K223892
• Device Name: DentMix VPS Impression Material
• Applicant: Innovative Product Brands, Inc.
• Product Code: ELW · Dental
• Decision Date: Apr 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended 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.

Device Story

DentMix VPS Impression Material is an addition-reaction polyviny/siloxane (VPS) dental impression material; serves as alternative to traditional alginate. Available in regular and fast set variants; includes light body (Type 3), regular body/monophase (Type 2), and heavy body (Type 1) viscosities. Used by dental professionals in clinical settings to capture dental anatomy for crown, bridge, occlusal, and implant procedures. Material is applied to impression trays or directly to oral structures; sets to form a physical mold of teeth and gums. Output is a high-fidelity physical impression used by dentists and dental laboratories to fabricate dental restorations or appliances. Benefits include accurate reproduction of subgingival details and structural anatomy, facilitating precise clinical decision-making for restorative dentistry.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4823-2015 standards. Testing compared physical properties of DentMix VPS (heavy, monophase, light body) against predicate Elements™ across metrics including consistency (mm), working time (min/sec), detail reproduction (pass/fail), linear dimensional change (%), gypsum compatibility (pass/fail), elastic recovery (%), and strain-in-compression (%). Results demonstrate performance characteristics substantially equivalent to the predicate device.

Technological Characteristics

Addition-reaction polyviny/siloxane (VPS) impression material. Composition includes vinyl polysiloxane, filler, and pigments. Complies with ISO 4823-2015. Available in three viscosities: light body (Type 3), regular body/monophase (Type 2), and heavy body (Type 1).

Indications for Use

Indicated for use in patients requiring crown, bridge, occlusal, or implant impressions to reproduce tooth and gum structures.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Elements™ (K151150)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 ● [phone] ● Fax [phone] www.ipbinc.com

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Image /page/4/Picture/0 description: The image shows the logo for IPB Inc. The letters "IPB" are in a large, bold, blue font. Below the letters, the words "Innovative Product Brands" are in a smaller, black font. To the right of the letters, the word "Inc" is in a smaller, black font.

| Descriptive<br>Information | Subject Device<br>DentMix VPS Impression<br>Material (K223892) | Predicate Device<br>Elements™ (K151150) | Summary |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | DentMix VPS Impression<br>Material is intended for use<br>with all crown and bridge,<br>occlusal and implant<br>impression techniques to<br>reproduce the structure of a<br>patient's teeth and gums. | Elements™ is intended for use<br>with all crown and bridge,<br>occlusal and implant impression<br>techniques to reproduce the<br>structure of a patient's teeth and<br>gums. | The indications for use<br>of the subject and<br>predicate devices are<br>intended for use with<br>all crown and bridge,<br>occlusal and implant<br>impression techniques<br>to reproduce the<br>structure of a patient's<br>teeth and gums. |
| Composition of<br>Materials | Vinyl Polysiloxane<br>Filler<br>Pigments | Vinyl Polysiloxane<br>Filler<br>Pigments | The composition of the<br>subjective and<br>predicate devices<br>are the same. |
| Mode of Use | 1. Light body (Type 3)<br>A low viscosity impression<br>material used to capture<br>extraordinary subgingival<br>details.<br>2. Regular body/Monophase<br>(Type 2)<br>A medium viscosity monophase<br>impression<br>material used in single step<br>impression procedures.<br>3. Heavy body (Type 1)<br>A heavy body impression<br>material used as base in<br>two-step heavy-wash<br>applications. | 1. Light body (Type 3)<br>A low viscosity impression<br>material used to capture<br>extraordinary subgingival<br>details.<br>2. Regular body/Monophase<br>(Type 2)<br>A medium viscosity monophase<br>impression<br>material used in single step<br>impression procedures.<br>3. Heavy body (Type 1)<br>A heavy body impression<br>material used as base in<br>two-step heavy-wash<br>applications. | The mode of use of the<br>subjective and<br>predicate devices<br>are the same. |
| FDA-Recognized<br>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<br>(K223892) | | | Elements TM ( K151150) | | |
|-------------------------------|-----------------------------------------------|--------------|-----------------|------------------------|--------------|-----------------|
| | Heavy<br>Body | Monophase | Light<br>Body | Heavy<br>Body | Monophase | Light<br>Body |
| Mixing Time | N/A | N/A | N/A | N/A | N/A | N/A |
| Consistency | 32mm | 35mm | 40mm | 31mm | 35mm | 39mm |
| Working Time<br>(Regular Set) | 2'34" | 2'12" | 2'37" | 2'30" | 2'30" | 2'30" |
| Working Time (Fast<br>Set) | 1'16" | 1'23" | 1'21" | 1'30" | 1'30" | 1'30" |
| Detail Reproduction | PASS | PASS | PASS | PASS | PASS | PASS |
| Linear Dimensional<br>Change | 0.14%<br>(0.01) | 0.05% (0.02) | 0.08%<br>(0.02) | 0.14%<br>(0.01) | 0.05% (0.02) | 0.08%<br>(0.02) |
| Compatibility with<br>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-<br>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.