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)

Q: Who is the manufacturer of 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)?

Prevest Denpro Limited filed the 510(k) submission for 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) (K213244).

Q: What is the FDA product code for 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)?

ELW. It is classified under 21 CFR 872.3660 as a Class 2 device in the Dental panel.

Q: What is the regulatory pathway for 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)?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for 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)?

Dynax Dental Impression Material (K171562).

Q: Who can help prepare an FDA 510(k) submission like 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)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K213244 · Prevest Denpro Limited · ELW · Sep 9, 2022 · Dental

Device Facts

Record ID	K213244
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)
Applicant	Prevest Denpro Limited
Product Code	ELW · Dental
Decision Date	Sep 9, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3660
Device Class	Class 2

Intended 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.

Device Story

Accusil Dental Impression Materials are two-component (base and catalyst) silicone-based impression materials. Components are mixed in a 1:1 ratio, loaded into a preformed impression tray, and inserted into the patient's mouth by a dental professional. The material conforms to the patient's dentition and sets to create a physical reproduction of teeth and occlusion. Used in clinical dental settings to facilitate the fabrication of crowns, bridges, and restorative devices. The resulting impression provides the dentist with an accurate model of the patient's oral anatomy, aiding in the design and fit of dental prosthetics.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4823 and ISO 48-4 standards. Metrics included working time, detail reproduction, linear dimensional change, consistency, Shore hardness, compatibility with gypsum, elastic recovery, and strain in compression. All test results met established criteria.

Technological Characteristics

Room temperature vulcanizing (RTV) two-component silicone impression material. Composition: vinyl-terminated polydimethylsiloxanes, fillers, platinum catalyst, SIH capped polysiloxane. Form factors: 50ml double cartridges, 380ml 5:1 cartridges, or 150ml/300ml plastic jars. Non-sterile. Testing per ISO 4823 and ISO 48-4.

Indications for Use

Indicated for use in reproducing the structure of a patient's teeth and gums for dental applications including crowns, bridges, occlusal models, and dental implant restorative devices.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

Dynax Dental Impression Material (K171562)

Reference Devices

Fresh Impression Material (K053427)
President the Original (K220097)
Aquasil Ultra + (K152861)

Related Devices

K171562 — Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono · Dreve Dentamid GmbH · Apr 13, 2018
K143382 — DentiAnn Smart Sil · Seilglobal Co., Ltd. · Feb 23, 2015
K201483 — Impression Material · Zhengzhou Huaer Electro Optics Technology Co., Ltd. · Oct 8, 2020
K241924 — Elastic Impression Material · Beijing Okvd Biological Technology , Ltd. · Dec 27, 2024
K222741 — DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) · Hdi, Inc. · Nov 7, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. 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. {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 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 {2}------------------------------------------------ # 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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: 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. {4}------------------------------------------------ # 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 (light body, heavy body, monophase, putty and bite registration) | Dynax (clear, putty, heavy body, light, mono) predicate device | Fresh Impression Material (reference device for ingredients) | President the Original (reference device for ingredients) | Aquasil Ultra + (reference device for ingredients) | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k Number | K213244 | K171562 | K053427 | K220097 | K152861 | | Common Name | Impression material | Impression material | Impression material | Impression material | Impression material | | Classification Name | Impression material | Impression material | Impression material | Impression material | Impression material | | 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 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. | Dynax 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. | Fresh Dental Impression material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums. | PRESIDENT The Original Xtra light body / light body / regular body: * Correction material for the corrective impression technique * Injection material for the double mix technique * Injection material for the dual arch technique)) * Lining impression material PRESIDENT The Original heavy body: * Impression material for pick-up impression in the double mix technique * Tray material for corrective impression technique * Tray material for dual arch technique PRESIDENT The Original System 360: * Impression material for pick-up | Aquasil® Ultra + Smart Wetting® Impression Material is indicated for all dental impression techniques. | | Material | | | | | | | | | | | the double mix technique | | | | | | | * Tray material for corrective impression technique | | | | | | | * Tray material for dual arch technique | | | | | | | PRESIDENT The Original putty / putty soft / putty super soft / fast putty soft | | | | | | | * Impression material for pick-up impression in the double mix technique | | | | | | | * Tray material for corrective impression technique | | | Material | Accusil light, heavy, mono, and bite registration: Mixture of vinyl terminated polydimethylsilox anes and filler materials with platinum catalyst and SIH capped polysiloxane Accusil putty: Mixture of vinyl terminated polydimethylsilox anes and filler materials with | Dynax putty, light, mono, and heavy body: Mixture of vinyl terminated polydimethylsi loxanes and filler materials with platinum catalyst and methylhydrosi loxane dimethylsiloxa ne copolymers Dynax clear: Mixture of vinyl terminated | Fresh Bold liquid putty, light body, monophase and heavy body: Mixture of vinyl terminated polydimethylsi loxanes and filler materials with platinum catalyst and methylhydrosi loxane dimethylsiloxa ne copolymers Fresh Bold clear bite: | Divinylpolydime thylsiloxanes, silicon dioxide, zeolite, Platinum(0)- 1,3-divinyl- 1,1,3,3- tetramethyldisil oxane complex solution, Titanium dioxide, iron oxides, organic pigments, and surfactants | Polydimethyl siloxane polymer, polymethylhydrog en siloxane, silicon dioxide, sodium aluminosiliicate (zeolite), organic platinum complex, titanium dioxide, iron oxide pigments, organic pigments, other pigments. Surfactants, peppermint oil | | | platinum catalyst and SIH capped polysiloxane plus softener | polydi- methylsiloxan es and silicic acid with platinum catalyst and methylhydrosi loxane dimethylsiloxa ne copolymers | Mixture of vinyl terminated polydimethylsi loxanes and silic acid with platinum catalyst and methylhydrosi loxane dimethylsiloxa ne copolymers | | | | Working/Processi ng Time | 40-150 sec | 90 sec | 90-120 sec | unknown | 35-105 sec | | Setting time/Time in 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 | | Dimensional accuracy | 99.9%-99.2% | 99.9%-99.2% | 99.9% - 99.2% | 99.8%-99.2% | 98% | | Stability (linear dimensional change) | <0.8% typical | <0.2% typical | <0.1% typical | unknown | <0.50% typical | | Consistency | Type 0-type 3 ISO 4823 | Type 0-type 3 ISO 4823 | Type 0-type 3 ISO 4823 | Type 1-type 3 ISO 4823 | Type 1-type 3 ISO 4823 | | Chemical Description | Room temperature vulcanizing 2- components silicone | Room temperature vulcanizing 2- components silicone | Room temperature vulcanizing 2- components silicone | Room temperature vulcanizing 2- components silicone | Room temperature vulcanizing 2- components silicone | | Package | Accusil bite registration, heavy, light, and monophase come in 2 x 50 ml double cartridges Monophase regular also comes in a 5:1 380ml double cartridges. Accusil putty comes in plastic jars of 150ml and 300ml for both base and catalyst. | Dynax putty in tubs of 2x35 ml and 2 x 450 ml Dynax light, mono, heavy body, and clear are sold in 50 ml double cartridges | Fresh Bold liquid putty in tubs of 2 x 450 ml Fresh Bold light body, monophase, heavy body and clear bite in 2x 50 ml double cartridges | Primary packaging Tubes, Pots or cartridges Secondary packaging: Folding carton | Primary packaging Tubes, Pots or cartridges Secondary packaging: Folding carton | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ | Method of manipulation | Preformed impression tray | Preformed impression tray | Preformed impression tray | Preformed impression tray | Preformed impression 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.