(344 days)
No
The device is a physical dental impression material and the description focuses on its material properties and performance testing according to ISO standards, with no mention of AI or ML.
No
The device is for reproducing the structure of teeth and gums for crowns, bridges, and other dental devices, not for therapeutic intervention.
No
This device is an impression material used to reproduce the structure of teeth and gums, not to diagnose a condition. It is used to create models for crowns, bridges, and other dental devices.
No
The device is a physical dental impression material, not software. The description details its chemical composition and physical properties, and the performance studies focus on material characteristics.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to reproduce the structure of a patient's teeth and gums for producing dental prosthetics. This is a physical process of creating a mold, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a material that is mixed, placed in the mouth, and sets to create a physical impression. It doesn't involve analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Purpose: IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis.
- Testing: The testing described focuses on the physical properties of the material (working time, detail reproduction, dimensional change, hardness, etc.), which are relevant to its function as an impression material, not its diagnostic accuracy.
Therefore, Accusil Dental Impression Material is a medical device used for creating physical impressions, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
ELW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth and gums
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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)
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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) |