(134 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of alginate impression materials, with no mention of AI or ML.
No.
The device is used to take dental impressions for diagnostic models and for the production of prosthetic devices, but it does not directly treat or diagnose a disease or condition itself.
No
The device itself (alginate impression material) is used to take anatomical data and create a mold. While the mold can then be used by a dentist to diagnose problems, the alginate material itself is not performing the diagnostic function; it enables the creation of a diagnostic tool.
No
The device description clearly states it is an "irreversible hydrocolloid impression material made from seaweed," which is a physical substance, not software. The performance studies also focus on physical properties of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Identic and KromaFaze Alginate Dental Impression Materials are used to create a physical mold of the patient's mouth. This mold is then used for diagnosis and planning, but the material itself is not analyzing a biological sample in vitro.
- Intended Use: The intended use clearly states the device is used 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." This describes a physical impression process, not an in vitro diagnostic test.
- Device Description: The description reinforces that it's an "irreversible hydrocolloid impression material" used to "take primary or preliminary impressions."
While the resulting plaster mold is used for diagnostic purposes, the alginate material itself is a tool for creating that mold, not a diagnostic test performed on a biological sample.
N/A
Intended Use / 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 chectiveness. 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 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. Alginate impressions are taken to obtain diagnostic study models, which are the positive reproductions of the teeth and surrounding structures. Identic Alginate is cinnamon flavored and comes in three options - Regular Set, Fast Set, and Extra Fast Set. KromaFaze Alginate is mint flavored and comes in two options – Regular Set and Fast Set. KromaFaze Alginate has a color change feature that offers a visual guide for consistent impression making.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's mouth, teeth and gums
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by the dentist.
Licensed dental professionals.
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 Identic and KromaFaze Alginate Impression 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
- 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 results were that the proposed devices Passed all tests, including:
- Mixing time per ISO 1563: Pass 30"
- Working time per ISO 1563: Pass 2'20" (Regular Set), Pass 1'45" (Fast Set), Pass 1'15" (Extra Fast Set)
- Setting time per ISO 1563: Pass ≤3'30" (Regular Set), Pass ≤2'20" (Fast Set), Pass ≤2'00" (Extra Fast Set)
- Homogeneous Mixed Material ISO 1563: 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
- Recovery from deformation (%) per ISO 1563: ≥95% Pass
- Strain in compression ISO 1563: Between 5% and 20% Pass
- Compressive strength per ISO 1563: ≥0.35 MPa Pass
- Dimensional Changes at 100 hours: Pass ≤ 2% when compared to a mold
Clinical performance testing has not been performed for Identic and KromaFaze Alginate Dental Impression Materials.
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.
Kromopan Impression Material (K121824)
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
§ 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).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2016
Kerr Corporation c/o Mr. Mohammad Ansari Regulatory Affairs Specialist Sybron Dental Specialties 1717 W. Collins Ave. Orange, California 92867
Re: K160441
Trade/Device Name: Identic and KromaFaze Alginate Dental Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 19, 2016 Received: May 23, 2016
Dear Mr. Ansari:
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.
1
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 (QS) 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
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160441
Device Name
Identic and KromaFaze Alginate Dental Impression Materials
Indications for Use (Describe)
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 chectiveness. 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 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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3
510(k) SUMMARY for Identic and KromaFaze Alginate Dental Impression Materials
1. Submitter Information:
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92867
| Contact Person: | Mohammad Saad Ansari |
|---|---|
| Telephone Number: | 909-962-5644 |
| Fax Number: | 909-962-5694 |
Date Prepared: June 22, 2016
2. Device Name:
| • | Proprietary Name: | Identic and KromaFaze Alginate Dental Impression
Materials |
|---|----------------------|---------------------------------------------------------------|
| • | Common Name: | Dental Impression Material |
| • | Classification Name: | Impression Material |
| • | CFR Number: | 872.3660 |
| • | Device Class: | 2 |
ELW . Product Code:
3. Predicate Device:
The Identic Alginate and KromaFaze Alginate product lines are substantially equivalent to the legally marketed device Kromopan Impression Material (K121824) cleared on August 23, 2012, product code ELW.
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. Alginate impressions are taken to obtain diagnostic study models, which are the positive reproductions of the teeth and surrounding structures. Identic Alginate is cinnamon flavored and comes in three options - Regular Set, Fast Set, and Extra Fast Set. KromaFaze Alginate is mint flavored and comes in two options – Regular Set and Fast Set. KromaFaze Alginate has a color change feature that offers a visual guide for consistent impression making.
4
| Accessories Used with
| Identic and KromaFaze | Manufacturer of Accessory |
|---|---|
| Impression Tray | DUX Dental |
| 600 East Hueneme Road | |
| Oxnard, CA 93033 USA |
5. 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.
Description of Safety and Substantial Equivalence: 6.
Technological Characteristics
The designs of Identic and KromaFaze Alginate are similar to the predicate Kromopan Impression Material (K121824), 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.
Identic and KromaFaze are only different in the color changing feature and flavorings, otherwise the chemistry is equivalent. KromaFaze has a color change feature that provides visual indication and guide for impression making.
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 Identic and KromaFaze Alginate Impression 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 ●
5
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
| Element | Predicate
Kromopan | Proposed
Identic Alginate | Proposed
KromaFaze Alginate |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K121824 | To be assigned | To be assigned |
| Trade Name | Kromopan | Identic Alginate | KromaFaze Alginate |
| Target Users | Licensed dental
professionals | Licensed dental
professionals | Licensed dental
professionals |
| Device Description | Kromopan is an elastic,
irreversible hydrocolloid
impression material. | Identic Alginate is an
elastic irreversible
hydrocolloid impression
material | KromaFaze 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. |
| 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 |
| Color Change | Yes | No | Yes |
| Material Compatibility | Unknown | Biocompatibility meets
requirements | Biocompatibility meets
requirements |
| Shelf Life | 60 months based on real
time data | 24 months based on real
time data | 24 months based on real
time data |
| Mixing time per ISO
1563 | Type I = 1'45"
Type II = 2'45" | Pass 30" | Pass 30" |
| Working time per ISO
1563 | Type I = 1'45"
Type II = 2'45" | Pass 2'20"
(Regular Set) | Pass 2'20"
(Regular Set) |
| | | Pass 1'45"
(Fast Set) | Pass 1'45"
(Fast Set) |
| | | Pass 1'15"
(Extra Fast Set) | |
| Setting time per ISO
1563 | 30" | Pass ≤3'30"
(Regular Set) | Pass ≤3'30"
(Regular Set) |
| | | Pass ≤2'20"
(Fast Set) | Pass ≤2'20"
(Fast Set) |
| Element | Predicate
Kromopan | Proposed
Identic Alginate | Proposed
KromaFaze Alginate |
| Homogeneous Mixed
Material ISO 1563 | Unknown | Pass ≤2'00"
(Extra Fast Set)
Pass | Pass |
| Compatibility with
gypsum and
reproduction of detail
(μm) ISO 1563 | Type I = 20
Type II = 20 | 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 | 95.5 | ≥95%
Pass | ≥95%
Pass |
| Strain in compression
ISO 1563 | Unknown | Between 5% and 20%
Pass | Between 5% and 20%
Pass |
| Compressive strength
per ISO 1563 | Unknown | ≥0.35 MPa
Pass | ≥0.35 MPa
Pass |
| Dimensional Changes
at 100 hours | 100 hours | Pass
≤ 2% when compared to a
mold | Pass
≤ 2% when compared to a
mold |
| Configurations/Dimen
sions | Carton box containing
20x450g bags (9 kg.) | 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 | Unknown | 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 | Unknown | 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 | Unknown | 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 | Unknown | 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 |
Table 5.1: Predicate and Proposed Device Comparison Table
6
7
Clinical Performance Data
Clinical performance testing has not been performed for Identic and KromaFaze Alginate Dental Impression Materials.
Intended Use
The Intended Use for Identic and KromaFaze Alginate Dental Impression Materials is identical to the predicate, Kromopan (K121824).
Identic and 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.
Conclusion as to Substantial Equivalence
The technological characteristics of Identic and KromaFaze Alginate are very similar to the predicate, Kromopan (K121824). The intended uses of the proposed and predicate products are similar. The only major differences between KromaFaze and Identic are in a color changing feature and flavorings. These proposed products have an equivalent chemical principle of function, setting mechanism, and have similar 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 Identic and KromaFaze Alginate Impression Materials are substantially equivalent to the predicate device Kromopan Impression Material (K121824) based on the design, performance, biocompatibility testing, and the intended use. Known differences between the proposed product and predicate device include shelf life, mixing times, working times, and setting times. 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, Identic and KromaFaze Alginate is substantially equivalent to the predicate, Kromopan Impression Material (K121824).