(134 days)
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.
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.
The provided text describes the 510(k) premarket notification for "Identic and KromaFaze Alginate Dental Impression Materials." This document focuses on demonstrating substantial equivalence to a predicate device (Kromopan Impression Material, K121824) rather than proving that an AI-driven device meets specific acceptance criteria through a study involving human readers or sophisticated ground truth establishment.
Therefore, many of the requested details about acceptance criteria, study design for AI, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information are not applicable to this type of medical device submission.
This submission is for a dental impression material, which is a physical material, not an AI/software device. The "performance data" refers to the physical properties of the material itself.
However, I can extract the acceptance criteria and performance related to the physical properties of the dental impression material as presented in the document.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document uses the ISO 1563:1990 standard for Dental Elastic Impression Materials, Part 2 Alginate Dental Impression Material, as the basis for acceptance criteria for most physical properties. The "acceptance criteria" are implied by the standard's requirements, which the devices are stated to "Pass."
| Element (Acceptance Criteria Implicitly from ISO 1563) | Predicate Kromopan Performance (for comparison) | Proposed Identic Alginate Performance | Proposed KromaFaze Alginate Performance | Meets Acceptance Criteria? |
|---|---|---|---|---|
| Mixing time | Type I = 1'45", Type II = 2'45" | Pass 30" | Pass 30" | Yes (Pass) |
| Working time | Type I = 1'45", Type II = 2'45" | Pass 2'20" (Regular Set), Pass 1'45" (Fast Set), Pass 1'15" (Extra Fast Set) | Pass 2'20" (Regular Set), Pass 1'45" (Fast Set) | Yes (Pass) |
| Setting time | 30" | Pass ≤3'30" (Regular Set), Pass ≤2'20" (Fast Set), Pass ≤2'00" (Extra Fast Set) | Pass ≤3'30" (Regular Set), Pass ≤2'20" (Fast Set) | Yes (Pass) |
| Homogeneous Mixed Material | Unknown | Pass | Pass | Yes (Pass) |
| Compatibility with gypsum and reproduction of detail (μm) | 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 | Yes (Pass) |
| Recovery from deformation (%) | 95.5 | ≥95%, Pass | ≥95%, Pass | Yes (Pass) |
| Strain in compression | Unknown | Between 5% and 20%, Pass | Between 5% and 20%, Pass | Yes (Pass) |
| Compressive strength | Unknown | ≥0.35 MPa, Pass | ≥0.35 MPa, Pass | Yes (Pass) |
| Dimensional Changes at 100 hours | 100 hours | Pass ≤ 2% when compared to a mold | Pass ≤ 2% when compared to a mold | Yes (Pass) |
| Biocompatibility | Unknown | Meets requirements | Meets requirements | Yes |
| Shelf Life | 60 months based on real time data | 24 months based on real time data | 24 months based on real time data | Yes (Stated as conforming) |
Notes:
- The term "Acceptance Criteria" is not explicitly defined with numerical thresholds in the table, but implied by compliance with ISO 1563 and the "Pass" status.
- "Unknown" for predicate indicates the specific data point for the predicate was not provided in the comparison table, but the predicate itself was cleared.
- "N/A" (Not Applicable) for certain flow, viscosity, and wettability properties indicates these properties do not apply to alginate impression materials.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes (e.g., number of impressions or tests performed) for each physical property test. It only states that "Non-clinical performance data included testing for..." various properties.
- Data Provenance: The document states that "Biocompatibility testing was performed at a third party laboratory." No country of origin is specified for the testing data. The data is non-clinical performance data, likely from laboratory testing rather than human subject studies (as indicated by "Clinical performance testing has not been performed"). Therefore, the terms retrospective or prospective do not apply in the context of clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable. This submission is for a physical dental material, not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The "ground truth" for these tests are the objective measurements of the material's physical and chemical properties as defined by ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing consensus ground truth, typically in the context of diagnostic interpretations (e.g., by radiologists). The testing reported here is for the physical properties of a material, which are measured objectively.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This is not an algorithm or software device. It is a physical dental impression material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical performance data (physical and chemical properties) is established by conformance to internationally recognized standards (ISO 1563:1990, ISO 10993 series) through validated laboratory test methods. There is no expert consensus on case interpretations, pathology, or outcomes data used for the "ground truth" of material properties.
8. The sample size for the training set
- This is not applicable. This device is a physical material, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
- This is not applicable, as there is no training set for this type of device.
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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.
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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 (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
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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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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 ImpressionMaterials |
|---|---|---|
| • | 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.
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| Accessories Used withIdentic and KromaFaze | Manufacturer of Accessory |
|---|---|
| Impression Tray | DUX Dental600 East Hueneme RoadOxnard, 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 ●
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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 | PredicateKromopan | ProposedIdentic Alginate | ProposedKromaFaze Alginate |
|---|---|---|---|
| 510(k) | K121824 | To be assigned | To be assigned |
| Trade Name | Kromopan | Identic Alginate | KromaFaze Alginate |
| Target Users | Licensed dentalprofessionals | Licensed dentalprofessionals | Licensed dentalprofessionals |
| Device Description | Kromopan is an elastic,irreversible hydrocolloidimpression material. | Identic Alginate is anelastic irreversiblehydrocolloid impressionmaterial | KromaFaze 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. |
| Setting Mechanism | Reaction of alginates andcalcium sulfate withwater | Reaction of alginates andcalcium sulfate withwater | Reaction of alginates andcalcium sulfate withwater |
| Color Change | Yes | No | Yes |
| Material Compatibility | Unknown | Biocompatibility meetsrequirements | Biocompatibility meetsrequirements |
| Shelf Life | 60 months based on realtime data | 24 months based on realtime data | 24 months based on realtime data |
| Mixing time per ISO1563 | Type I = 1'45"Type II = 2'45" | Pass 30" | Pass 30" |
| Working time per ISO1563 | 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 ISO1563 | 30" | Pass ≤3'30"(Regular Set) | Pass ≤3'30"(Regular Set) |
| Pass ≤2'20"(Fast Set) | Pass ≤2'20"(Fast Set) | ||
| Element | PredicateKromopan | ProposedIdentic Alginate | ProposedKromaFaze Alginate |
| Homogeneous MixedMaterial ISO 1563 | Unknown | Pass ≤2'00"(Extra Fast Set)Pass | Pass |
| Compatibility withgypsum andreproduction of detail(μm) ISO 1563 | Type I = 20Type II = 20 | 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 |
| Recovery fromdeformation (%) perISO 1563 | 95.5 | ≥95%Pass | ≥95%Pass |
| Strain in compressionISO 1563 | Unknown | Between 5% and 20%Pass | Between 5% and 20%Pass |
| Compressive strengthper ISO 1563 | Unknown | ≥0.35 MPaPass | ≥0.35 MPaPass |
| Dimensional Changesat 100 hours | 100 hours | Pass≤ 2% when compared to amold | Pass≤ 2% when compared to amold |
| Configurations/Dimensions | Carton box containing20x450g bags (9 kg.) | 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 | Unknown | N/A as the material is apowder that sets uponmixing with water. Theproperty does not applyto Alginates, only toimpression pastes. | N/A as the material is apowder that sets uponmixing with water. Theproperty does not applyto Alginates, only toimpression pastes. |
| Viscosity | Unknown | Not Applicable; as thematerial is a powder thatsets upon mixing withwater. Viscosity propertydoes not apply toAlginates, onlyimpression pastes. | Not Applicable; as thematerial is a powder thatsets upon mixing withwater. Viscosity propertydoes not apply toAlginates, onlyimpression pastes. |
| Wettability | Unknown | N/A as the material is apowder that sets uponmixing with water. Theproperty does not applyto Alginates, only toimpression pastes. | N/A as the material is apowder that sets uponmixing with water. Theproperty does not applyto Alginates, only toimpression pastes. |
| Working Humidity | Unknown | Working/Setting Timeper ISO 1563 is tested inhumidity chamber atrelease | Working/Setting Timeper ISO 1563 is tested inhumidity chamber atrelease |
Table 5.1: Predicate and Proposed Device Comparison Table
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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).
§ 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).