Image Fast Set, Image Regular Set

• K Number: K160097
• Device Name: Image Fast Set, Image Regular Set
• Manufacturer: Sybron Dental Specialties
• Date Cleared: 2016-08-05 ( 199 days)
• Product Code: ELW
• Regulation Number: 872.3660

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 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.

Predicate Devices

K160441

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and chemical properties of the alginate material, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No
The device is used to take dental impressions to create models for diagnosis and production of restorative prosthetic devices, not to directly treat or cure a disease or condition.

Diagnostic

Yes.

The device's intended use states it is "useful to diagnose problems" and produces "diagnostic study models."

SaMD (Software as a Medical Device)

No

The device description clearly states it is an alginate impression material, which is a physical substance used to take dental impressions. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to take anatomical data of the patient's mouth to create a plaster mold for diagnosis, planning interventions, and checking effectiveness. It's also used to create models for study and production of restorative prosthetic devices. This is a physical impression of the oral cavity, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
• Device Description: The device is an impression material used to create a physical mold. It doesn't analyze biological samples like blood, urine, or tissue.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.

While the resulting plaster mold can be used for diagnosis, the alginate material itself is a tool for capturing the physical form of the oral cavity, not a diagnostic test performed on biological material.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 chectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Product codes (comma separated list FDA assigned to the subject device)

ELW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's mouth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dentist

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)

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
• 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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160441

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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 [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)
	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:

• 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
Identic and KromaFaze | Manufacturer of
Accessory |
|------------------------------------------------|-------------------------------------------------------------|
| Impression Tray | DUX Dental
600 East Hueneme Road
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
Identic Alginate
(K160441) | Predicate
KromaFaze Alginate
(K160441) | Proposed
Image Alginate
(K160097) |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K160441 | K160441 | K160097 |
| Trade Name | Identic Alginate | KromaFaze Alginate | Image Alginate |
| Target Users | Licensed dental
professionals | Licensed dental
professionals | Licensed dental
professionals |
| Device Description | Identic is an elastic.
irreversible hydrocolloid
impression material. | KromaFaze Alginate is an
elastic irreversible
hydrocolloid impression
material | Image Alginate is an
elastic irreversible
hydrocolloid impression
material |
| Common Name | Alginate Impression
Material | Alginate Impression
Material | Alginate Impression
Material |
| Classification Name | Impression Material,
Dental | Impression Material,
Dental | Impression Material,
Dental |
| Class | 2 | 2 | 2 |
| Product Code | ELW | ELW | ELW |
| Storage | Store at room
temperature. | Store at room
temperature. | Store at room
temperature. |
| Indications for Use | Identic 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. | KromaFaze 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. | 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. |
| Setting Mechanism | Reaction of alginates and
calcium sulfate with
water | Reaction of alginates and
calcium sulfate with
water | Reaction of alginates and
calcium sulfate with water |
| Element | Predicate
Identic Alginate
(K160441) | Predicate
KromaFaze Alginate
(K160441) | Proposed
Image Alginate
(K160097) |
| Color Change | No | Yes | No |
| Material
Compatibility | Biocompatibility meets
requirements | Biocompatibility meets
requirements | Biocompatibility meets
requirements |
| Shelf Life | 24 months based on real
time data | 24 months based on real
time data | 24 months based on real
time data |
| Mixing time
per ISO | Pass 30" | Pass 30" | Pass 30" |
| Working time
per 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 time
per 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 Mixed
Material ISO 1563 | Pass | Pass | Pass |
| Compatibility with
gypsum and
reproduction of
detail (µm)
ISO 1563 | Imparts a smooth surface
to, and separates cleanly
from, a gypsum cast.
Impression reproduces 50
µm line.
Pass | Imparts a smooth surface
to, and separates cleanly
from, a gypsum cast.
Impression reproduces 50
µm line.
Pass | Imparts a smooth surface
to, and separates cleanly
from, a gypsum cast.
Impression reproduces
50 µm line.
Pass |
| Recovery from
deformation (%)
per ISO 1563 | ≥95%
Pass | ≥95%
Pass | ≥95%
Pass |
| Element | Predicate
Identic Alginate
(K160441) | Predicate
KromaFaze Alginate
(K160441) | Proposed
Image Alginate
(K160097) |
| Compressive strength
per ISO 1563 | ≥0.35 MPa
Pass | ≥0.35 MPa
Pass | ≥0.35 MPa
Pass |
| Dimensional Changes
at 100 hours | ≤ 2% when compared to a
Mold
Pass | ≤ 2% when compared to a
Mold
Pass | ≤ 2% when compared to a
Mold
Pass |
| Configurations/
Dimensions | 1 lb. (454 g) bag and a
singles pack of 18 g | 1 lb. (454 g) bag and a
singles pack of 18 g | 1 lb. (454 g) bag and a
singles pack of 18 g |
| Method of Mixing | Mixing of powder with
water | Mixing of powder with
water | Mixing of powder with
water |
| Flow Properties | N/A as the material is a
powder that sets upon
mixing with water. The
property does not apply to
Alginates, only to
impression pastes. | N/A as the material is a
powder that sets upon
mixing with water. The
property does not apply to
Alginates, only to
impression pastes. | N/A as the material is a
powder that sets upon
mixing with water. The
property does not apply to
Alginates, only to
impression pastes. |
| Viscosity | Not Applicable; as the
material is a powder that
sets upon mixing with
water. Viscosity property
does not apply to
Alginates, only impression
pastes. | Not Applicable; as the
material is a powder that
sets upon mixing with
water. Viscosity property
does not apply to
Alginates, only impression
pastes. | Not Applicable; as the
material is a powder that
sets upon mixing with
water. Viscosity property
does not apply to
Alginates, only
impression pastes. |
| Wettability | N/A as the material is a
powder that sets upon
mixing with water. The
property does not apply to
Alginates, only to
impression pastes. | N/A as the material is a
powder that sets upon
mixing with water. The
property does not apply to
Alginates, only to
impression pastes. | N/A as the material is a
powder that sets upon
mixing with water. The
property does not apply to
Alginates, only to
impression pastes. |
| Working Humidity | Working/Setting Time
per ISO 1563 is tested in
humidity chamber at
release | Working/Setting Time
per ISO 1563 is tested in
humidity chamber at
release | Working/Setting Time
per ISO 1563 is tested
in humidity chamber at
release |

Predicate and Proposed Device Comparison Table

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| Chemical
Composition | Function | Predicate
Identic Alginate
(K160441) | Predicate
KromaFaze Alginate
(K160441) | Proposed
Image Alginate
(K160097) |
|--------------------------------|------------------------------------------------------------|--------------------------------------------|----------------------------------------------|-----------------------------------------|
| Dicalite speedex | Filler | 70 – 80 % | 70 – 80 % | 70 – 80 % |
| Magnesium oxide | Modifier and Filler |