Image Fast Set, Image Regular Set

K160097 · Sybron Dental Specialties · ELW · Aug 5, 2016 · Dental

Device Facts

• Record ID: K160097
• Device Name: Image Fast Set, Image Regular Set
• Applicant: Sybron Dental Specialties
• Product Code: ELW · Dental
• Decision Date: Aug 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Image Alginate Dental Impression Materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Device Story

Image Alginate is an elastic, irreversible hydrocolloid impression material derived from seaweed; supplied as a powder. Used by dentists to take primary/preliminary impressions of teeth and gums. Powder mixed with water to form a gel that solidifies into an elastic mass; creates a negative reproduction of the oral cavity. Output is a physical impression used to produce positive diagnostic study models, bleaching trays, or mouth guards. Used in dental clinics. Healthcare providers use the resulting plaster models to diagnose dental problems, plan interventions, and fabricate prosthetic devices. Benefits include accurate anatomical reproduction for restorative dentistry.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included work time, dimensional changes, set time, mixing time, gypsum compatibility, compressive strength, and biocompatibility (ISO 10993-1, ISO 10993-5).

Technological Characteristics

Irreversible hydrocolloid (alginate) powder. Materials: Dicalite speedex, magnesium oxide, sodium benzoate, zinc borate, potassium titanium fluoride, tetra sodium pyrophosphate, potassium alginate, gypsum, mineral oil, pigment, mint flavor. Compliant with ISO 1563:1990. Shelf life: 24 months. Storage: room temperature.

Indications for Use

Indicated for use by dentists to capture anatomical data of the patient's mouth to create plaster molds for diagnosis, treatment planning, and fabrication of restorative prosthetic devices (e.g., gold inlays, dentures).

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

• Identic Alginate (K160441)
• KromaFaze Alginate (K160441)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 5, 2016

Sybron Dental Specialties Mr. Gerardo Lara Regulatory Affairs Specialist 1717 W. Collins Ave Orange, California 92867

Re: K160097

Trade/Device Name: Image Alginate Dental Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: June 24, 2016 Received: June 28, 2016

Dear Mr. Lara:

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. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160097

Device Name Image Alginate Dental Impression Materials

### Indications for Use (Describe)

Image Alginate Dental Impression materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or chectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="text-decoration: line-through;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) SUMMARY For Image Alginate Dental Impression Materials K160097

- 1. Submitter Information:
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92867

| Contact Person: | Gerardo Lara |
|-------------------|--------------|
| Telephone Number: | 909-962-5771 |
| Fax Number: | 909-962-5694 |

August 2, 2016 Date Prepared:

- 2. Device Name:
- Proprietary Name: •
- Common Name: •
- Classification Name: Impression Material .
- . CFR Number:
- Device Class: • 2
- Product Code: ELW •

#### 3. Predicate Device:

The Image Alginate product lines are substantially equivalent to the legally marketed devices Identic Alginate and KromaFaze Alginate product lines cleared on June 3000, 2016 (K160441), product code ELW.

872.3660

Image Alginate Dental Impression Materials

Dental Impression Material

4. Description of Device:

Alginate impression materials are elastic, irreversible hydrocolloid impression materials made from seaweed. They are used to take primary or preliminary impressions of a patient's teeth and gums. This colloidal material forms a gel when the powder is mixed with water. It solidifies into an elastic mass capable of producing a negative reproduction of the oral cavity (an impression). Alginate impressions are taken to obtain diagnostic study models, which are the positive reproductions of the teeth and surrounding structures. They are also used to fabricate bleaching trays and mouth guards. Alginate is the most universally utilized impression material in dentistry. Image Alginate is a green-colored, mint flavored alginate and comes in two options Regular Set, Fast Set. The packaging configurations include a 1 lb. (454 g) bag and a singles pack of 18 g.

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| Accessories Used with<br>Identic and KromaFaze | Manufacturer of<br>Accessory |
|------------------------------------------------|-------------------------------------------------------------|
| Impression Tray | DUX Dental<br>600 East Hueneme Road<br>Oxnard, CA 93033 USA |

#### న్. Indications for Use:

Image Alginate Dental Impression Materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

#### Description of Safety and Substantial Equivalence: 6.

Technological Characteristics

The designs of Image Alginate are very similar to the predicate Identic and KromaFaze Impression Material (K160441), as they are all alginates used as general dental and orthodontic impression materials. They are all considered class II impression materials compliant to ISO 1563:1990 for Dental Elastic Impression Materials Part 2 Alginate dental impression material. The differences between the proposed and predicate devices include the flavor. Image Alginate is mint flavored, KromaFaze is mint flavored with a color change feature, and Identic is cinnamon flavored. Identic is offered in an extra fast set configuration, while KromaFaze Alginate and Image Alginate are not.

# Non-Clinical Performance Data

Non-clinical performance data included testing for Work time, Dimensional Changes, Set Time, Mixing Time, Biodegradable Components, Derivatives, Dust Prevention, Mixing Ratio, Warm/Hard Water Setting, Cold Water Setting, Towel Wrap Dimensional Changes, Full Setting, Singles Mixing Ratio, Color & Scent, Smooth Surface, Gypsum Compatibility, Compressive Strength, Powder Uniformity, Homogeneous Material, Penetration Value, Elastic Recovery, Strain in Compression, Gypsum Cast Material, Color Change for KromaFaze, as well as Biocompatibility and Stability testing.

Following the assessment route in ISO 10993-1:2009 Biological Evaluation of Medical Devices, Annex A, Biocompatibility testing was performed at a third party laboratory and testing results proved the proposed Image Alginate Alginate Impression material met the biocompatibility requirement.

The following standards were utilized for the non-clinical performance testing:

- Guidance for Industry and FDA Staff: Dental Impression Materials -Premarket Notification [510(k)] Submissions, August 17, 1998
- . ISO 1563:1990 for Dental Elastic Impression Materials part 2 Alginate dental impression material

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- ISO 10993-1: 2009 Biological Evaluation of Medical Devices ●
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for . in Vitro Cytotoxicity

| Element | Predicate<br>Identic Alginate<br>(K160441) | Predicate<br>KromaFaze Alginate<br>(K160441) | Proposed<br>Image Alginate<br>(K160097) |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K160441 | K160441 | K160097 |
| Trade Name | Identic Alginate | KromaFaze Alginate | Image Alginate |
| Target Users | Licensed dental<br>professionals | Licensed dental<br>professionals | Licensed dental<br>professionals |
| Device Description | Identic is an elastic.<br>irreversible hydrocolloid<br>impression material. | KromaFaze Alginate is an<br>elastic irreversible<br>hydrocolloid impression<br>material | Image Alginate is an<br>elastic irreversible<br>hydrocolloid impression<br>material |
| Common Name | Alginate Impression<br>Material | Alginate Impression<br>Material | Alginate Impression<br>Material |
| Classification Name | Impression Material,<br>Dental | Impression Material,<br>Dental | Impression Material,<br>Dental |
| Class | 2 | 2 | 2 |
| Product Code | ELW | ELW | ELW |
| Storage | Store at room<br>temperature. | Store at room<br>temperature. | Store at room<br>temperature. |
| Indications for Use | Identic Alginate Dental<br>Impression Materials are<br>irreversible hydrocolloids<br>for dental impressions used<br>by the dentist to take the<br>anatomical data of the<br>patient's mouth and<br>subsequently realize a<br>plaster mold useful to<br>diagnose problems, define<br>the required interventions<br>and/or check their<br>effectiveness. The device<br>is intended to provide<br>models for study and for<br>production of restorative<br>prosthetic devices, such as<br>gold inlays and dentures. | KromaFaze Alginate<br>Dental Impression<br>Materials are irreversible<br>hydrocolloids for dental<br>impressions used by the<br>dentist to take the<br>anatomical data of the<br>patient's mouth and<br>subsequently realize a<br>plaster mold useful to<br>diagnose problems, define<br>the required interventions<br>and/or check their<br>effectiveness. The device<br>is intended to provide<br>models for study and for<br>production of restorative<br>prosthetic devices, such as<br>gold inlays and dentures. | Image Alginate Dental<br>Impression Materials are<br>irreversible hydrocolloids<br>for dental impressions<br>used by the dentist to take<br>the anatomical data of the<br>patient's mouth and<br>subsequently realize a<br>plaster mold useful to<br>diagnose problems, define<br>the required interventions<br>and/or check their<br>effectiveness. The device<br>is intended to provide<br>models for study and for<br>production of restorative<br>prosthetic devices, such as<br>gold inlays and dentures. |
| Setting Mechanism | Reaction of alginates and<br>calcium sulfate with<br>water | Reaction of alginates and<br>calcium sulfate with<br>water | Reaction of alginates and<br>calcium sulfate with water |
| Element | Predicate<br>Identic Alginate<br>(K160441) | Predicate<br>KromaFaze Alginate<br>(K160441) | Proposed<br>Image Alginate<br>(K160097) |
| Color Change | No | Yes | No |
| Material<br>Compatibility | Biocompatibility meets<br>requirements | Biocompatibility meets<br>requirements | Biocompatibility meets<br>requirements |
| Shelf Life | 24 months based on real<br>time data | 24 months based on real<br>time data | 24 months based on real<br>time data |
| Mixing time<br>per ISO | Pass 30" | Pass 30" | Pass 30" |
| Working time<br>per ISO 1563 | Pass 2'20"<br>(Regular Set) | Pass 2'20"<br>(Regular Set) | Pass 2'20"<br>(Regular Set) |
| | Pass 1'45"<br>(Fast Set) | Pass 1'45"<br>(Fast Set) | Pass 1'45"<br>(Fast Set) |
| | Pass 1'15"<br>(Extra Fast Set) | | |
| Setting time<br>per ISO 1563 | Pass ≤3'30"<br>(Regular Set) | Pass ≤3'30"<br>(Regular Set) | Pass ≤3'30"<br>(Regular Set) |
| | Pass ≤2'20"<br>(Fast Set) | Pass ≤2'20"<br>(Fast Set) | Pass ≤2'20"<br>(Fast Set) |
| | Pass ≤2'00"<br>(Extra Fast Set) | | |
| Homogeneous Mixed<br>Material ISO 1563 | Pass | Pass | Pass |
| Compatibility with<br>gypsum and<br>reproduction of<br>detail (µm)<br>ISO 1563 | Imparts a smooth surface<br>to, and separates cleanly<br>from, a gypsum cast.<br>Impression reproduces 50<br>µm line.<br>Pass | Imparts a smooth surface<br>to, and separates cleanly<br>from, a gypsum cast.<br>Impression reproduces 50<br>µm line.<br>Pass | Imparts a smooth surface<br>to, and separates cleanly<br>from, a gypsum cast.<br>Impression reproduces<br>50 µm line.<br>Pass |
| Recovery from<br>deformation (%)<br>per ISO 1563 | ≥95%<br>Pass | ≥95%<br>Pass | ≥95%<br>Pass |
| Element | Predicate<br>Identic Alginate<br>(K160441) | Predicate<br>KromaFaze Alginate<br>(K160441) | Proposed<br>Image Alginate<br>(K160097) |
| Compressive strength<br>per ISO 1563 | ≥0.35 MPa<br>Pass | ≥0.35 MPa<br>Pass | ≥0.35 MPa<br>Pass |
| Dimensional Changes<br>at 100 hours | ≤ 2% when compared to a<br>Mold<br>Pass | ≤ 2% when compared to a<br>Mold<br>Pass | ≤ 2% when compared to a<br>Mold<br>Pass |
| Configurations/<br>Dimensions | 1 lb. (454 g) bag and a<br>singles pack of 18 g | 1 lb. (454 g) bag and a<br>singles pack of 18 g | 1 lb. (454 g) bag and a<br>singles pack of 18 g |
| Method of Mixing | Mixing of powder with<br>water | Mixing of powder with<br>water | Mixing of powder with<br>water |
| Flow Properties | N/A as the material is a<br>powder that sets upon<br>mixing with water. The<br>property does not apply to<br>Alginates, only to<br>impression pastes. | N/A as the material is a<br>powder that sets upon<br>mixing with water. The<br>property does not apply to<br>Alginates, only to<br>impression pastes. | N/A as the material is a<br>powder that sets upon<br>mixing with water. The<br>property does not apply to<br>Alginates, only to<br>impression pastes. |
| Viscosity | Not Applicable; as the<br>material is a powder that<br>sets upon mixing with<br>water. Viscosity property<br>does not apply to<br>Alginates, only impression<br>pastes. | Not Applicable; as the<br>material is a powder that<br>sets upon mixing with<br>water. Viscosity property<br>does not apply to<br>Alginates, only impression<br>pastes. | Not Applicable; as the<br>material is a powder that<br>sets upon mixing with<br>water. Viscosity property<br>does not apply to<br>Alginates, only<br>impression pastes. |
| Wettability | N/A as the material is a<br>powder that sets upon<br>mixing with water. The<br>property does not apply to<br>Alginates, only to<br>impression pastes. | N/A as the material is a<br>powder that sets upon<br>mixing with water. The<br>property does not apply to<br>Alginates, only to<br>impression pastes. | N/A as the material is a<br>powder that sets upon<br>mixing with water. The<br>property does not apply to<br>Alginates, only to<br>impression pastes. |
| Working Humidity | Working/Setting Time<br>per ISO 1563 is tested in<br>humidity chamber at<br>release | Working/Setting Time<br>per ISO 1563 is tested in<br>humidity chamber at<br>release | Working/Setting Time<br>per ISO 1563 is tested<br>in humidity chamber at<br>release |

# Predicate and Proposed Device Comparison Table

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| Chemical<br>Composition | Function | Predicate<br>Identic Alginate<br>(K160441) | Predicate<br>KromaFaze Alginate<br>(K160441) | Proposed<br>Image Alginate<br>(K160097) |
|--------------------------------|------------------------------------------------------------|--------------------------------------------|----------------------------------------------|-----------------------------------------|
| Dicalite speedex | Filler | 70 – 80 % | 70 – 80 % | 70 – 80 % |
| Magnesium oxide | Modifier and Filler | <1 % | <1 % | <1 % |
| Sodium benzoate | Anti-Microbial and<br>Preservative | <1 % | <1 % | <1 % |
| Zinc Borate | Anti-Microbial and<br>Preservative | <2 % | <2 % | <2 % |
| Potassium titanium<br>fluoride | Surface for Gypsum | 1.5 - 3.5 % | 1 - 3 % | 1.5 - 3.5 % |
| Tetra sodium<br>pyrophosphate | Retarder to Adjust<br>Set Time | <2 % | <1 % | <2 % |
| Potassium alginate | Reactant | 3-8% | 3 - 8 % | 3 - 8 % |
| Potassium alginate<br>Kimica | Reactant | 3 - 8 % | 3 - 8 % | 3 - 8 % |
| Terra Alba (gypsum) | Reactant | 3-8% | 3 - 8 % | 3 - 8 % |
| Mineral Oil | Reduction of<br>Dusting | <2 % | <2 % | <2 % |
| Xanthan gum | Thickening Agent | N/A | <2 % | N/A |
| Trisodium phosphate | Emulsifier and<br>Thickening Agent | N/A | <2 % | N/A |
| Phenolphthalein | pH Indicator<br>Causing Color<br>Change Above ~<br>10.0 pH | N/A | <1 % | N/A |
| Thymophthalein | pH Indicator<br>Causing Color<br>Change Above ~<br>10.5 pH | N/A | <1 % | N/A |
| Pigment signal green | Coloring | N/A | N/A | <2 % |
| Pigment rocket red | Coloring | <1 % | N/A | N/A |
| Flavor natural mint | Flavoring Agent | N/A | <1 % | <1 % |
| Flavor cinnamon | Flavoring Agent | <1 % | N/A | N/A |

Clinical Performance Data

Clinical performance testing has not been performed for Image Alginate Dental Impression Materials.

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## Intended Use

The Intended Use for Image Alginate Dental Impression Materials is identical to that for the predicate, Identic Alginate and KromaFaze Alginate product lines (K160441).

Image Alginate Dental Impression Materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

## Conclusion as to Substantial Equivalence

The technological characteristics of Image Alginate are very similar to KromaFaze and Identic Alginate (K160441). The intended uses of the proposed and predicate products are identical. The only major differences between KromaFaze, Identic, and Image are in a color changing feature and flavorings. These proposed product Image Alginate has an equivalent chemical principle of function, setting mechanism, and have identical delivery systems as compared to the predicate. The proposed and predicate products also share similarities in mechanism of action, preparation times, and select performance characteristics relevant to impression materials. The proposed Image Alginate Impression Materials are substantially equivalent to Identic and KromaFaze Alginate Impression Materials (K160441) based on the design, performance, biocompatibility testing, and the intended use. Any noted differences in technological characteristics between the proposed and predicate products do not affect the intended use, do not raise new questions of safety and effectiveness, and demonstrate the proposed product is at least as safe and effective as the legally marketed predicate device. Based on this reasoning and the results of performance testing based on ISO 1563:1990 and biocompatibility testing. Image is substantially equivalent to the predicate, Identic and KromaFaze Alginate (K160441).