(86 days)
Not Found
No
The description focuses on the material properties and physical characteristics of a silicone impression material, with no mention of AI or ML.
No
The device is described as an impression material for taking oral impressions, and its performance studies confirm it conforms to ISO 4823 for impression materials. It does not exert a therapeutic effect.
No
Explanation: The device is an impression material used for taking oral impressions, which is a method of capturing the physical form of oral structures. It is not described as analyzing or interpreting data to diagnose a medical condition or disease. Its function is to create a mold, not to provide diagnostic information.
No
The device description clearly states it is a silicone impression material, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "taking oral impressions." This is a physical process for creating a mold of oral structures, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a silicone impression material. It's a physical substance used to create a mold.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information.
- Performance Studies: The performance studies focus on physical properties of the material (dimensional change, elastic recovery, strain-in compression) according to a standard for dental impression materials (ISO 4823). This is consistent with a physical impression material, not a diagnostic test.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for medical purposes. This device's function is purely mechanical – creating a physical impression.
N/A
Intended Use / Indications for Use
AIM2 is a silicone impression material for taking oral impressions.
Product codes
ELW
Device Description
AIM2 is a VPS silicone impression material. The components consist of the base silicone paste and the catalyst silicone paste that are extruded from a cartridge and are automixed with a mixing tip. AIM2 is available in one viscosity.
The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Tests
It is confirmed that the device conforms to the required specifications according to ISO 4823 and is suitable for its intended use.
Technological Characteristics
The curing mechanism is described as an addition silicone reaction. It is an addition polymerization between vinyl polysiloxanes and poly-me,-siloxanes hydrogen terminated. A platinum complex is used as a catalyst. A side reaction may occur and release small quantity of hydrogen gas. Therefore, palladium is used as a scavenger. A surfactant is added to allow wettability/hydrophilicity.
Setting for AIM2 is 3 minutes in the mouth.
Results of benchtop testing indicate the physical properties such as linear dimensional change, elastic recover and strain-in compression met the specification set in ISO 4823.
Biological safety test data shows the biocompatibility of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GC America Inc. Mark Heiss, DDS Director. Regulatory Affairs 3737 W. 127th Street Alsip, Illinois 60803
July 12, 2018
Re: K181011
Trade/Device Name: AIM2 Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: May 17, 2018 Received: May 21, 2018
Dear Mark Heiss:
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4 - Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| K181011 | |
| Device Name | |
AIM 2
Indications for Use (Describe)
AIM2 is a silicone impression material for taking oral impressions.
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)
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."
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740 EF
3
Image /page/3/Picture/1 description: The image shows the letters 'GC' in a stylized, sans-serif font. The letters are a teal color, and there are single quotation marks before and after the letters. The letters are slightly italicized, giving them a dynamic appearance.
GC AMERICA INC
3737 W 127th STREET
ALSIP, ILLINOIS 60803
TEL (708) 597-0900
FAX (708) 926-9100
www.gcamerica.com
Date Prepared: April 16, 2018
-
- Submitter Information:
- GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803
| Contact Person: | Mark Heiss, D.D.S. |
|---|---|
| Phone: | (708) 926-3090 |
| Alternate Contact: | Lori Rietman |
| Phone: | (708) 926-3092 |
| Fax: | (708) 926-9100 |
-
- Device Name:
- Proprietary Name: AIM2 Classification Name: Material, Impression CFR Regulation: 21CFR 872.3660 Device Classification: Class II Product Code: ELW
-
- Predicate Devices:
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| GC America Inc. | EXAFLEX/EXAMIX Impression Material | K955932 | March 11,1996 |
-
- Description of Device:
AIM2 is a VPS silicone impression material. The components consist of the base silicone paste and the catalyst silicone paste that are extruded from a cartridge and are automixed with a mixing tip. AIM2 is available in one viscosity.
- Description of Device:
The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.
-
న. Indications for Use:
AIM2 is a silicone impression material for taking oral impression. -
- Performance Bench Tests
It is confirmed that the device conforms to the required specifications according to ISO 4823 and is suitable for its intended use.
- Performance Bench Tests
Packaging 11.
- a) AIM2, 2-Pk; contains two cartridges and 6 mixing tips
- b) Mixing Tip II: L
7. Shelf Life Evaluation and Storage Conditions:
- Shelf Life 2 years ।
- Recommended for optimal performance, store at room temperature. 15-25°C (59.0 77.0°F) (Relative । humidity: 50%).
4
| Applicant device | Predicate device | |
|---|---|---|
| Product | ||
| category | Hydrophilic vinyl polysiloxane impression | |
| material | Hydrophilic vinyl polysiloxane impression | |
| material | ||
| Trade name | AIM2 | EXAMIX |
| Manufacturer | GC Corporation | GC Corporation |
| Indications for | ||
| use | AIM2 is a silicone impression material for taking | |
| oral impression. | EXAMIX is a silicone impression material for | |
| taking oral impression. | ||
| Product | ||
| description | The device consists of the base paste and the | |
| catalyst paste Including VPS. | ||
| The material sets by mixing the catalyst paste | ||
| with the base paste. | The device consists of the base paste and the | |
| catalyst paste Including VPS. | ||
| The material sets by mixing the catalyst paste | ||
| with the base paste. | ||
| Instructions | ||
| for use | Note: The cartridge and mixing tip provided are | |
| compatible with GC Cartridge Dispenser 2. | ||
| CARTRIDGE LOADING AND DISPENSING |
- Lift the release lever of the CARTRIDGE
DISPENSER 2. (referred to as the dispenser
hereafter) and pull the piston plunger all the way
back into the dispenser. Lift the cartridge holder
of the dispenser and load the cartridge, ensuring
that the V-shaped notch on the flange of the
cartridge is facing down. Push the cartridge
holder down to hold the cartridge firmly in place. - Lift the release lever and push the piston
plunger forward until it engages into the
cartridge. - Remove the cartridge cap by rotating 1/4 turn
anti-clockwise. Tilt the cap downward and peel it
away from the cartridge. Gently squeeze the
dispenser handle to extrude a small amount of
material from the two openings at the end of
cartridge. Make sure that base and catalyst
come out evenly. - Align the V-shaped notch on the rim of mixing
tip to the V-shaped notch between the cartridge
barrels. Push firmly to attach the mixing tip.
Then rotate the colored collar of the mixing tip
1/4 turn clockwise to the end of the cartridge.
The dispenser is now ready for use. - Squeeze the handle several times to extrude
the material. After use, do not remove the
mixing tip as this will become the storage cap
until next use. When replacing the mixing tip,
rotate the collar on the mixing tip 1/4 turn anti-
clockwise to align the V-shaped notch on the
cartridge. Tilt the mixing tip downward and peel
it away from the cartridge. - Remove and replace the old mixing tip
immediately prior to next use. Before attaching a
new tip, gently extrude a small amount of
material to ensure that base and catalyst are
flowing evenly from both openings. If the
materials should fail to extrude, remove any
hardened materials from the end of the
cartridge. - To replace the cartridge, lift the release lever
and retract the piston plunger fully. Remove the
empty cartridge by lifting the cartridge holder
and load a new one into the dispenser.
USING THE IMPRESSION MATERIAL
Note: Prior to use, leave the material to stand at
room temperature. Cooled or refrigerated
material may delay setting. | Note: The cartridge and mixing tip provided are
compatible with GC Cartridge Dispenser 2.
CARTRIDGE LOADING AND DISPENSING - Lift the release lever of the CARTRIDGE
DISPENSER 2. (referred to as the dispenser
hereafter) and pull the piston plunger all the way
back into the dispenser. Lift the cartridge holder
of the dispenser and load the cartridge, ensuring
that the V-shaped notch on the flange of the
cartridge is facing down. Push the cartridge
holder down to hold the cartridge firmly in place. - Lift the release lever and push the piston
plunger forward until it engages into the
cartridge. - Remove the cartridge cap by rotating 1/4 turn
anti-clockwise. Tilt the cap downward and peel it
away from the cartridge. Gently squeeze the
dispenser handle to extrude a small amount of
material from the two openings at the end of
cartridge. Make sure that base and catalyst
come out evenly. - Align the V-shaped notch on the rim of mixing
tip to the V-shaped notch between the cartridge
barrels. Push firmly to attach the mixing tip.
Then rotate the colored collar of the mixing tip
1/4 turn clockwise to the end of the cartridge.
The dispenser is now ready for use. - Squeeze the handle several times to extrude
the material. After use, do not remove the mixing
tip as this will become the storage cap until next
use. When replacing the mixing tip, rotate the
collar on the mixing tip 1/4 turn anti-clockwise to
align the V-shaped notch on the cartridge. Tilt
the mixing tip downward and peel it away from
the cartridge. - Remove and replace the old mixing tip
immediately prior to next use. Before attaching a
new tip, gently extrude a small amount of
material to ensure that base and catalyst are
flowing evenly from both openings. If the
materials should fail to extrude, remove any
hardened materials from the end of the
cartridge. - To replace the cartridge, lift the release lever
and retract the piston plunger fully. Remove the
empty cartridge by lifting the cartridge holder
and load a new one into the dispenser.
USING THE IMPRESSION MATERIAL
Note: Prior to use, leave the material to stand at
room temperature. Cooled or refrigerated
material may delay setting. |
| | 1. Attach an intraoral tip to the mixing tip or load
material into a syringe. 2. Inject the mixture onto the prepared teeth. 3. Load the tray with the material. | 1. Attach an intraoral tip to the mixing tip or load
material into a syringe. 2. Inject the mixture onto the prepared teeth. 3. Load the tray with the appropriate material (putty, monophase, heavy body or regular - depending on technique being used). |
| | 4. Seat the loaded tray in the mouth within
specified working times. 5. Wait for set 3 minutes in the mouth). 6. The obtained impression should be cleaned, then disinfected, utilizing a 2.5% or 3.4% glutaraldehyde, or other appropriate disinfectant, according to the manufacturers label recommendations. 7. Remove the impression and pour a model immediately (if desired). Maximum time for pouring the model is 14 days. | 4. Seat the loaded tray in the mouth within
specified working times. 5. Wait for set 4 minutes in the mouth). 6. The obtained impression should be cleaned, then disinfected, utilizing a 2.5% or 3.4% glutaraldehyde, or other appropriate disinfectant, according to the manufacturers label recommendations. 7. Remove the impression and pour a model immediately (if desired). Maximum time for pouring the model is 14 days. |
| Technological
Characteristics | The curing mechanism is described as an
addition silicone reaction. It is an addition
polymerization between vinyl polysiloxanes and
poly-me,-siloxanes hydrogen terminated. A
platinum complex is used as a catalyst. A side
reaction may occur and release small quantity of
hydrogen gas. Therefore, palladium is used as a
scavenger. A surfactant is added to allow
wettability/hydrophilicity.
Setting for AIM2 is 3 minutes in the mouth.
Results of benchtop testing indicate the physical
properties such as linear dimensional change,
elastic recover and strain-in compression met
the specification set in ISO 4823.
Biological safety test data shows the
biocompatibility of the predicate device. | The curing mechanism is described as an
addition silicone reaction. It is an addition
polymerization between vinyl
dimethylpolysiloxane and methylhydrogen
dimethylpolysiloxane. A platinum complex is
used as a catalyst. A surfactant is added to allow
wettability/hydrophilicity.
Setting time for Examix is 4 minutes in the
mouth.
Results of benchtop testing indicate the physical
properties such as linear dimensional change,
elastic recovery and strain-in compression meet
the specification set in ISO 4823.
Biological safety test data shows the
biocompatibility of the predicate device. |
Table 5.1.1 Comparison Table
5
8. Substantial equivalence:
The applicant and predicate device are the same in function and intended use. The curing mechanism of the applicant and predicate device is substantially equivalent in principle. This supports that the compatibility and safety of the applicant device is substantially equivalent to the predicate device.
Although there are slight differences in bench top performance tests, results meet requirements as outlined in ISO 4823:2015.
9. Differences
The following differences are noted: setting time for AIM2 is 3 minutes in the mouth and Examix is 4 minutes in mouth.
10. Conclusion
Based on similarities in intended use, mode of action, chemical composition, and performance testing, AIM2 is substantially equivalent to the selected predicate Examix (K955932).