Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Device Description

Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.

AI/ML Overview

The document describes the acceptance criteria and performance of Accusil Dental Impression Materials as part of a 510(k) premarket notification for FDA clearance.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that Accusil Dental Impression Materials were tested against specific ISO standards (ISO 4823 and ISO 48-4) and internal protocols. The "Acceptance Criteria" are implicitly derived from the requirements of these standards. The "Reported Device Performance" for Accusil is provided in the comparative table with predicate and reference devices.

Performance Characteristic	Accusil Dental Impression Materials (Reported Performance)	Acceptance Criteria (Implicit from ISO standards and comparison with predicate/references)
Working/Processing Time	40-150 sec	Similar to predicate (90 sec) and reference devices (35-120 sec).
Setting time/Time in the mouth	60-300 sec	Similar to predicate (90 sec) and reference devices (120-330 sec).
Hardness	63-70 Shore A	Similar to predicate (46-70 Shore A) and reference devices (42-75 Shore A).
Working Humidity	50%	Matches predicate (50%).
Dimensional Accuracy	99.9%-99.2%	Similar to predicate (99.9%-99.2%) and reference devices (98%-99.9%).
Stability (Linear Dimensional Change)	<0.8% typical	Similar to predicate (<0.2% typical) and reference devices (<0.1% to <0.50% typical).
Consistency	Type 0-type 3 ISO 4823	Matches predicate (Type 0-type 3 ISO 4823) and similar to reference (Type 1-type 3 ISO 4823).
Compatibility with Gypsum	All tests results met the criteria in standards.	Criteria specified in ISO 4823 for impression materials.
Elastic Recovery	All tests results met the criteria in standards.	Criteria specified in ISO 4823 for impression materials.
Strain in Compression	All tests results met the criteria in standards.	Criteria specified in ISO 4823 for impression materials.
Shelf Life	3 years	Established through relevant protocols, meeting specified criteria.
Biocompatibility	No biocompatibility testing was done.	Assumed to meet criteria due to similar ingredients and contact type as predicate/references, introducing no new risks.

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

Sample Size: Not explicitly stated in the provided text. The document mentions "Accusil light, heavy, monophase and putty were tested" and "Accusil bite registration was tested," implying samples of these product lines were used. However, the exact number of units or measurements for each test is not provided.
Data Provenance: The testing was performed by Prevest Denpro Limited, based in India ("Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India"). The nature of the testing (physical property measurements against international standards) suggests these were prospective tests conducted on manufactured samples, rather than retrospective data.

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

This information is not applicable to this type of device and study. The "ground truth" for dental impression materials is established by objective physical and chemical measurements against internationally recognized standards (ISO 4823, ISO 48-4), not by expert consensus or interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the evaluation involves objective physical property measurements against standardized criteria, there is no need for an adjudication method in the context of expert review. The results are quantitative and compared directly to standard specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging AI devices, not for physical property testing of dental impression materials.

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

No, a standalone AI algorithm performance study was not done. This is not an AI-driven device. The testing focused on the physical and chemical properties of the material itself.

7. The Type of Ground Truth Used:

The "ground truth" used for this device is based on objective standards and measurements of physical and chemical properties. Specifically, performance was evaluated against the requirements outlined in:

ISO 4823 (Dentistry - Elastomeric impression materials)
ISO 48-4 (Rubber, vulcanized or thermoplastic - Determination of hardness - Part 4: Indentation hardness by means of a durometer)
Internal protocols for setting time (as ISO 4823 does not specify setting time).

8. The Sample Size for the Training Set:

This information is not applicable. As this is not an AI/machine learning device, there is no "training set."

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

This information is not applicable for the same reason as point 8.

Summary

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September 9, 2022

Prevest Denpro Limited % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K213244

Trade/Device Name: Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: September 29, 2021 Received: September 30, 2021

Dear Angela Blackwell:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K213244

Device Name

Accusil Dental Impression Material: Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration

Indications for Use (Describe)

Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K213244

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) 510K Summary April 29, 2022

Name and Address:PrevestDenpro Limited Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India Contact Person: Atul Modi Email:prevestindia@gmail.com Telephone: (941) 919 4280

Name of device: Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)

Common name: impression material Classification Name: impression material CFR: 21 CFR 872.3660 Primary Product Code:ELW

Submission Contact:

Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com

Device Description:

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Indications for Use:

Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Testing Summary:

Accusil light, heavy, monophase and putty were tested with protocols meeting ISO 4823 and ISO 48-4 for working time, detail reproduction, linear dimensional change, consistency, Shore hardness, compatibility with gypsum, elastic recovery, and strain in compression. Setting time was tested using internal protocols (ISO 4823 does not have setting time). Accusil bite registration was tested with protocols meeting ISO 4823 and ISO 48-4 for working time, linear dimensional change, Shore hardness and compression and tested using an internal protocol for setting time.

Shelf life testing was completed on all devices using relevant protocols also used for the physical characteristics tested. Shelf life for impression materials is 3 years.

All tests results met the criteria in standards.

The impression materials contain ingredients found in the predicate and reference devices. They are used for the same type of contact, external communicating with contact to tissue/bone/dentin. The indications for use of the devices and the predicate devices are the risks incurred for use of the ingredients are the same. Since no new risks are introduced, no biocompatibility testing was done.

Predicate Device: Dynax Dental Impression Material K171562

Reference Devices: Fresh Impression Material K053427, President the Original, K220097, Aquasil Ultra + K152861

Substantial Equivalence:

The impression materials have similar ingredients to the predicate and reference devices, the same indications for use, and similar physical parameter testing.

Accusil Dental Impression Materials

Name	Accusil (lightbody, heavybody,monophase,putty and biteregistration)	Dynax (clear,putty, heavybody, light,mono)predicatedevice	FreshImpressionMaterial(referencedevice foringredients)	President theOriginal(referencedevice foringredients)	Aquasil Ultra +(referencedevice foringredients)
510k Number	K213244	K171562	K053427	K220097	K152861
Common Name	Impressionmaterial	Impressionmaterial	Impressionmaterial	Impressionmaterial	Impressionmaterial
ClassificationName	Impressionmaterial	Impressionmaterial	Impressionmaterial	Impressionmaterial	Impressionmaterial
Class	II	II	II	II	II
Product Code	ELW	ELW	ELW	ELW	ELW
CFR	872.3660	872.3660	872.3660	872.3660	872.3660
Indications for Use	Accusil dentalimpressionmaterial isintended to beplaced on apreformedimpression trayand used toreproduce thestructure of apatient's teethand gums.	Dynax dentalimpressionmaterial isintended tobe placed on apreformedimpressiontray and usedto reproducethe structureof a patient'steeth andgums.	Fresh DentalImpressionmaterial isintended foruse with allcrowns,bridges,occlusal anddental implantimpressiontechniques toreproduce thestructure of apatient'steeth andgums.	PRESIDENTThe OriginalXtra light body/ light body /regular body:* Correctionmaterial forthe correctiveimpressiontechnique* Injectionmaterial forthe doublemix technique* Injectionmaterial forthe dual archtechnique))* LiningimpressionmaterialPRESIDENTThe Originalheavy body:* Impressionmaterial forpick-upimpression inthe doublemix technique* Traymaterial forcorrectiveimpressiontechnique* Traymaterial fordual archtechniquePRESIDENTThe OriginalSystem 360:* Impressionmaterial forpick-up	Aquasil® Ultra+ SmartWetting®ImpressionMaterial isindicated forall dentalimpressiontechniques.
Material
				the doublemix technique
				* Traymaterial forcorrectiveimpressiontechnique
				* Traymaterial fordual archtechnique
				PRESIDENTThe Originalputty / puttysoft / puttysuper soft /fast putty soft
				* Impressionmaterial forpick-upimpression inthe doublemix technique
				* Traymaterial forcorrectiveimpressiontechnique
Material	Accusil light,heavy, mono,and biteregistration:Mixture of vinylterminatedpolydimethylsiloxanes and fillermaterials withplatinum catalystand SIH cappedpolysiloxaneAccusil putty:Mixture of vinylterminatedpolydimethylsiloxanes and fillermaterials with	Dynax putty,light, mono,and heavybody: Mixtureof vinylterminatedpolydimethylsiloxanes andfiller materialswith platinumcatalyst andmethylhydrosiloxanedimethylsiloxane copolymersDynax clear:Mixture ofvinylterminated	Fresh Boldliquid putty,light body,monophaseand heavybody: Mixtureof vinylterminatedpolydimethylsiloxanes andfiller materialswith platinumcatalyst andmethylhydrosiloxanedimethylsiloxane copolymersFresh Boldclear bite:	Divinylpolydimethylsiloxanes,silicon dioxide,zeolite,Platinum(0)-1,3-divinyl-1,1,3,3-tetramethyldisiloxane complexsolution,Titaniumdioxide, ironoxides, organicpigments, andsurfactants	Polydimethylsiloxane polymer,polymethylhydrogen siloxane,silicon dioxide,sodiumaluminosiliicate(zeolite), organicplatinumcomplex, titaniumdioxide, ironoxide pigments,organic pigments,other pigments.Surfactants,peppermint oil
	platinum catalystand SIH cappedpolysiloxane plussoftener	polydi-methylsiloxanes and silicicacid withplatinumcatalyst andmethylhydrosiloxanedimethylsiloxane copolymers	Mixture ofvinylterminatedpolydimethylsiloxanes andsilic acid withplatinumcatalyst andmethylhydrosiloxanedimethylsiloxane copolymers
Working/Processing Time	40-150 sec	90 sec	90-120 sec	unknown	35-105 sec
Setting time/Timein the mouth	60-300 sec	90 sec	120-140 sec	unknown	150-330 sec
Hardness	63-70 Shore A	46-70 Shore A	42-70 Shore A	50-75 Shore A	Unknown
Working humidity	50%	50%	50%	unknown	Unknown
Dimensionalaccuracy	99.9%-99.2%	99.9%-99.2%	99.9% - 99.2%	99.8%-99.2%	98%
Stability (lineardimensionalchange)	<0.8% typical	<0.2% typical	<0.1% typical	unknown	<0.50% typical
Consistency	Type 0-type 3ISO 4823	Type 0-type 3ISO 4823	Type 0-type 3ISO 4823	Type 1-type 3ISO 4823	Type 1-type 3ISO 4823
ChemicalDescription	Roomtemperaturevulcanizing 2-componentssilicone	Roomtemperaturevulcanizing 2-componentssilicone	Roomtemperaturevulcanizing 2-componentssilicone	Roomtemperaturevulcanizing 2-componentssilicone	Roomtemperaturevulcanizing 2-componentssilicone
Package	Accusil biteregistration,heavy, light, andmonophasecome in 2 x 50 mldouble cartridgesMonophaseregular alsocomes in a 5:1380ml doublecartridges.Accusil puttycomes in plasticjars of 150ml and300ml for bothbase andcatalyst.	Dynax putty intubs of 2x35ml and 2 x 450mlDynax light,mono, heavybody, andclear are soldin 50 mldoublecartridges	Fresh Boldliquid putty intubs of 2 x450 mlFresh Boldlight body,monophase,heavy bodyand clear bitein 2x 50 mldoublecartridges	PrimarypackagingTubes, Pots orcartridgesSecondarypackaging:Folding carton	Primary packagingTubes, Pots orcartridgesSecondarypackaging:Folding carton

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Method ofmanipulation	Preformedimpression tray	Preformedimpressiontray	Preformedimpressiontray	Preformedimpressiontray	Preformedimpression tray
Sterility	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile

Conclusion: Accusil dental impression materials are substantially equivalent to the predicate device, Dynax dental impression materials. They have the same indications, similar testing, and very similar ingredients. References devices contain ingredients not found in the predicate device but found in Accusil. Setting time, working time, hardness, working humidity, are similar to the predicate device and/or reference devices. The testing for these parameters for the subject device, predicate device, and reference devices are according to ISO 4823 so there are no differences in test methods. Since the test results are in the same ranges and the test methods are according to the same standard these results support the substantial equivalence of Accusil to Dynax. The subject devices, predicate devices, and reference devices all have the same method of manipulation, same working humidity, and same ISO 4823 types. Both the subject devices and the predicate device have physical parameters which meet requirements of the relevant ISO standards. Any differences in ingredients are minor and do not change the substantial equivalence.

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).