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.

Device Description

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.

AI/ML Overview

The document is a 510(k) Premarket Notification for "Image Alginate Dental Impression Materials" (K160097). It details the substantial equivalence of the proposed device to predicate devices (Identic Alginate and KromaFaze Alginate, K160441).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against the ISO 1563:1990 standard for Dental Elastic Impression Materials Part 2 Alginate dental impression material. The acceptance criteria are essentially the "Pass" values defined by this standard.

Element (Acceptance Criteria per ISO 1563)	Reported Device Performance (Image Alginate)
Mixing time	Pass 30"
Working time (Regular Set)	Pass 2'20"
Working time (Fast Set)	Pass 1'45"
Setting time (Regular Set)	Pass ≤3'30"
Setting time (Fast Set)	Pass ≤2'20"
Homogeneous Mixed Material	Pass
Compatibility with gypsum and reproduction of detail (50 µm line)	Imparts a smooth surface to, and separates cleanly from, a gypsum cast. Impression reproduces 50 µm line. Pass
Recovery from deformation (%)	≥95% Pass
Compressive strength	≥0.35 MPa Pass
Dimensional Changes at 100 hours	≤ 2% when compared to a Mold Pass
Material Compatibility (Biocompatibility)	Biocompatibility meets requirements
Shelf Life	24 months based on real time data

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific non-clinical performance test. It broadly mentions "Non-clinical performance data included testing for Work time, Dimensional Changes, Set Time, Mixing Time... etc." The data provenance is not specified regarding country of origin or whether it's retrospective or prospective, beyond stating that "Biocompatibility testing was performed at a third party laboratory."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the described studies are non-clinical, laboratory-based performance tests and biocompatibility assessments, not studies involving human interpretation or clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing has not been performed for Image Alginate Dental Impression Materials."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is a dental impression material, not an AI algorithm. The performance evaluation is for the material's physical and chemical properties.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" (or reference standard) is established by the ISO 1563:1990 standard for Dental Elastic Impression Materials Part 2 Alginate dental impression material. For biocompatibility, the ground truth is against ISO 10993-1:2009 and ISO 10993-5:2009 Biological Evaluation of Medical Devices. There is no mention of pathology or outcomes data as it is a non-clinical evaluation of a material.

8. The Sample Size for the Training Set

This is not applicable as the device is a material, not a machine learning model, and therefore does not have a "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized human figure in profile, with three faces overlapping to represent the department's focus on health and human well-being. The emblem is simple and modern in design.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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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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:

1. 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

Description of Device:

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Accessories Used withIdentic and KromaFaze	Manufacturer ofAccessory
Impression Tray	DUX Dental600 East Hueneme RoadOxnard, 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	PredicateIdentic Alginate(K160441)	PredicateKromaFaze Alginate(K160441)	ProposedImage Alginate(K160097)
510(k)	K160441	K160441	K160097
Trade Name	Identic Alginate	KromaFaze Alginate	Image Alginate
Target Users	Licensed dentalprofessionals	Licensed dentalprofessionals	Licensed dentalprofessionals
Device Description	Identic is an elastic.irreversible hydrocolloidimpression material.	KromaFaze Alginate is anelastic irreversiblehydrocolloid impressionmaterial	Image Alginate is anelastic irreversiblehydrocolloid impressionmaterial
Common Name	Alginate ImpressionMaterial	Alginate ImpressionMaterial	Alginate ImpressionMaterial
Classification Name	Impression Material,Dental	Impression Material,Dental	Impression Material,Dental
Class	2	2	2
Product Code	ELW	ELW	ELW
Storage	Store at roomtemperature.	Store at roomtemperature.	Store at roomtemperature.
Indications for Use	Identic Alginate DentalImpression Materials areirreversible hydrocolloidsfor dental impressions usedby the dentist to take theanatomical data of thepatient's mouth andsubsequently realize aplaster mold useful todiagnose problems, definethe required interventionsand/or check theireffectiveness. The deviceis intended to providemodels for study and forproduction of restorativeprosthetic devices, such asgold inlays and dentures.	KromaFaze AlginateDental ImpressionMaterials are irreversiblehydrocolloids for dentalimpressions used by thedentist to take theanatomical data of thepatient's mouth andsubsequently realize aplaster mold useful todiagnose problems, definethe required interventionsand/or check theireffectiveness. The deviceis intended to providemodels for study and forproduction of restorativeprosthetic devices, such asgold inlays and dentures.	Image Alginate DentalImpression Materials areirreversible hydrocolloidsfor dental impressionsused by the dentist to takethe anatomical data of thepatient's mouth andsubsequently realize aplaster mold useful todiagnose problems, definethe required interventionsand/or check theireffectiveness. The deviceis intended to providemodels for study and forproduction of restorativeprosthetic devices, such asgold inlays and dentures.
Setting Mechanism	Reaction of alginates andcalcium sulfate withwater	Reaction of alginates andcalcium sulfate withwater	Reaction of alginates andcalcium sulfate with water
Element	PredicateIdentic Alginate(K160441)	PredicateKromaFaze Alginate(K160441)	ProposedImage Alginate(K160097)
Color Change	No	Yes	No
MaterialCompatibility	Biocompatibility meetsrequirements	Biocompatibility meetsrequirements	Biocompatibility meetsrequirements
Shelf Life	24 months based on realtime data	24 months based on realtime data	24 months based on realtime data
Mixing timeper ISO	Pass 30"	Pass 30"	Pass 30"
Working timeper ISO 1563	Pass 2'20"(Regular Set)	Pass 2'20"(Regular Set)	Pass 2'20"(Regular Set)
	Pass 1'45"(Fast Set)	Pass 1'45"(Fast Set)	Pass 1'45"(Fast Set)
	Pass 1'15"(Extra Fast Set)
Setting timeper ISO 1563	Pass ≤3'30"(Regular Set)	Pass ≤3'30"(Regular Set)	Pass ≤3'30"(Regular Set)
	Pass ≤2'20"(Fast Set)	Pass ≤2'20"(Fast Set)	Pass ≤2'20"(Fast Set)
	Pass ≤2'00"(Extra Fast Set)
Homogeneous MixedMaterial ISO 1563	Pass	Pass	Pass
Compatibility withgypsum andreproduction ofdetail (µm)ISO 1563	Imparts a smooth surfaceto, and separates cleanlyfrom, a gypsum cast.Impression reproduces 50µm line.Pass	Imparts a smooth surfaceto, and separates cleanlyfrom, a gypsum cast.Impression reproduces 50µm line.Pass	Imparts a smooth surfaceto, and separates cleanlyfrom, a gypsum cast.Impression reproduces50 µm line.Pass
Recovery fromdeformation (%)per ISO 1563	≥95%Pass	≥95%Pass	≥95%Pass
Element	PredicateIdentic Alginate(K160441)	PredicateKromaFaze Alginate(K160441)	ProposedImage Alginate(K160097)
Compressive strengthper ISO 1563	≥0.35 MPaPass	≥0.35 MPaPass	≥0.35 MPaPass
Dimensional Changesat 100 hours	≤ 2% when compared to aMoldPass	≤ 2% when compared to aMoldPass	≤ 2% when compared to aMoldPass
Configurations/Dimensions	1 lb. (454 g) bag and asingles pack of 18 g	1 lb. (454 g) bag and asingles pack of 18 g	1 lb. (454 g) bag and asingles pack of 18 g
Method of Mixing	Mixing of powder withwater	Mixing of powder withwater	Mixing of powder withwater
Flow Properties	N/A as the material is apowder that sets uponmixing with water. Theproperty does not apply toAlginates, only toimpression pastes.	N/A as the material is apowder that sets uponmixing with water. Theproperty does not apply toAlginates, only toimpression pastes.	N/A as the material is apowder that sets uponmixing with water. Theproperty does not apply toAlginates, only toimpression pastes.
Viscosity	Not Applicable; as thematerial is a powder thatsets upon mixing withwater. Viscosity propertydoes not apply toAlginates, only impressionpastes.	Not Applicable; as thematerial is a powder thatsets upon mixing withwater. Viscosity propertydoes not apply toAlginates, only impressionpastes.	Not Applicable; as thematerial is a powder thatsets upon mixing withwater. Viscosity propertydoes not apply toAlginates, onlyimpression pastes.
Wettability	N/A as the material is apowder that sets uponmixing with water. Theproperty does not apply toAlginates, only toimpression pastes.	N/A as the material is apowder that sets uponmixing with water. Theproperty does not apply toAlginates, only toimpression pastes.	N/A as the material is apowder that sets uponmixing with water. Theproperty does not apply toAlginates, only toimpression pastes.
Working Humidity	Working/Setting Timeper ISO 1563 is tested inhumidity chamber atrelease	Working/Setting Timeper ISO 1563 is tested inhumidity chamber atrelease	Working/Setting Timeper ISO 1563 is testedin humidity chamber atrelease

Predicate and Proposed Device Comparison Table

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ChemicalComposition	Function	PredicateIdentic Alginate(K160441)	PredicateKromaFaze Alginate(K160441)	ProposedImage Alginate(K160097)
Dicalite speedex	Filler	70 – 80 %	70 – 80 %	70 – 80 %
Magnesium oxide	Modifier and Filler	<1 %	<1 %	<1 %
Sodium benzoate	Anti-Microbial andPreservative	<1 %	<1 %	<1 %
Zinc Borate	Anti-Microbial andPreservative	<2 %	<2 %	<2 %
Potassium titaniumfluoride	Surface for Gypsum	1.5 - 3.5 %	1 - 3 %	1.5 - 3.5 %
Tetra sodiumpyrophosphate	Retarder to AdjustSet Time	<2 %	<1 %	<2 %
Potassium alginate	Reactant	3-8%	3 - 8 %	3 - 8 %
Potassium alginateKimica	Reactant	3 - 8 %	3 - 8 %	3 - 8 %
Terra Alba (gypsum)	Reactant	3-8%	3 - 8 %	3 - 8 %
Mineral Oil	Reduction ofDusting	<2 %	<2 %	<2 %
Xanthan gum	Thickening Agent	N/A	<2 %	N/A
Trisodium phosphate	Emulsifier andThickening Agent	N/A	<2 %	N/A
Phenolphthalein	pH IndicatorCausing ColorChange Above ~10.0 pH	N/A	<1 %	N/A
Thymophthalein	pH IndicatorCausing ColorChange Above ~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).

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).

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).