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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the dental impression material AIM2. It focuses on demonstrating that AIM2 is substantially equivalent to a predicate device, EXAFLEX/EXAMIX Impression Material (K955932).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria mentioned are the specifications outlined in ISO 4823. The document states that the device conforms to these required specifications.

Acceptance Criterion (ISO 4823)	Reported Device Performance (AIM2)
Linear dimensional change (as per ISO 4823 specification)	Meets the specification set in ISO 4823
Elastic recovery (as per ISO 4823 specification)	Meets the specification set in ISO 4823
Strain-in compression (as per ISO 4823 specification)	Meets the specification set in ISO 4823
Biocompatibility (as demonstrated by predicate device's data)	Biological safety test data shows the biocompatibility of the predicate device
Curing mechanism (addition silicone reaction)	Addition silicone reaction (vinyl polysiloxanes and poly-me,-siloxanes hydrogen terminated)
Setting time in mouth (a technical characteristic, not an "acceptance criterion" per se, but a key performance parameter)	3 minutes

Note: The document explicitly states: "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." This is the direct evidence of meeting the acceptance criteria.

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

Sample Size for Test Set: The document does not specify the sample size used for the benchtop tests.
Data Provenance: The tests were "benchtop testing," which implies laboratory testing. The country of origin of the data is not specified, but the manufacturer is GC Corporation. The study is not a clinical trial, so the terms "retrospective" or "prospective" are not applicable in this context.

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

This information is not applicable as the study is a benchtop performance test against international standards (ISO 4823), not a study requiring expert interpretation of clinical data or images to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for a benchtop performance test.

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 information is not applicable. The device is an impression material, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is a physical impression material, not an algorithm.

7. The Type of Ground Truth Used:

For the performance tests, the "ground truth" or reference standard was the specifications outlined in ISO 4823. For biocompatibility, the document refers to the biological safety test data of the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical material and not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device does not involve a training set.

Summary

{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 SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See 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

1. 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

1. Device Name:
- Proprietary Name: AIM2 Classification Name: Material, Impression CFR Regulation: 21CFR 872.3660 Device Classification: Class II Product Code: ELW
1. Predicate Devices:

Company	Device	510(k) No.	Date Cleared
GC America Inc.	EXAFLEX/EXAMIX Impression Material	K955932	March 11,1996

1. 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.

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.
1. 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.

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
Productcategory	Hydrophilic vinyl polysiloxane impressionmaterial	Hydrophilic vinyl polysiloxane impressionmaterial
Trade name	AIM2	EXAMIX
Manufacturer	GC Corporation	GC Corporation
Indications foruse	AIM2 is a silicone impression material for takingoral impression.	EXAMIX is a silicone impression material fortaking oral impression.
Productdescription	The device consists of the base paste and thecatalyst paste Including VPS.The material sets by mixing the catalyst pastewith the base paste.	The device consists of the base paste and thecatalyst paste Including VPS.The material sets by mixing the catalyst pastewith the base paste.
Instructionsfor use	Note: The cartridge and mixing tip provided arecompatible with GC Cartridge Dispenser 2.CARTRIDGE LOADING AND DISPENSING1. Lift the release lever of the CARTRIDGEDISPENSER 2. (referred to as the dispenserhereafter) and pull the piston plunger all the wayback into the dispenser. Lift the cartridge holderof the dispenser and load the cartridge, ensuringthat the V-shaped notch on the flange of thecartridge is facing down. Push the cartridgeholder down to hold the cartridge firmly in place.2. Lift the release lever and push the pistonplunger forward until it engages into thecartridge.3. Remove the cartridge cap by rotating 1/4 turnanti-clockwise. Tilt the cap downward and peel itaway from the cartridge. Gently squeeze thedispenser handle to extrude a small amount ofmaterial from the two openings at the end ofcartridge. Make sure that base and catalystcome out evenly.4. Align the V-shaped notch on the rim of mixingtip to the V-shaped notch between the cartridgebarrels. Push firmly to attach the mixing tip.Then rotate the colored collar of the mixing tip1/4 turn clockwise to the end of the cartridge.The dispenser is now ready for use.5. Squeeze the handle several times to extrudethe material. After use, do not remove themixing tip as this will become the storage capuntil 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 thecartridge. Tilt the mixing tip downward and peelit away from the cartridge.6. Remove and replace the old mixing tipimmediately prior to next use. Before attaching anew tip, gently extrude a small amount ofmaterial to ensure that base and catalyst areflowing evenly from both openings. If thematerials should fail to extrude, remove anyhardened materials from the end of thecartridge.7. To replace the cartridge, lift the release leverand retract the piston plunger fully. Remove theempty cartridge by lifting the cartridge holderand load a new one into the dispenser.USING THE IMPRESSION MATERIALNote: Prior to use, leave the material to stand atroom temperature. Cooled or refrigeratedmaterial may delay setting.	Note: The cartridge and mixing tip provided arecompatible with GC Cartridge Dispenser 2.CARTRIDGE LOADING AND DISPENSING1. Lift the release lever of the CARTRIDGEDISPENSER 2. (referred to as the dispenserhereafter) and pull the piston plunger all the wayback into the dispenser. Lift the cartridge holderof the dispenser and load the cartridge, ensuringthat the V-shaped notch on the flange of thecartridge is facing down. Push the cartridgeholder down to hold the cartridge firmly in place.2. Lift the release lever and push the pistonplunger forward until it engages into thecartridge.3. Remove the cartridge cap by rotating 1/4 turnanti-clockwise. Tilt the cap downward and peel itaway from the cartridge. Gently squeeze thedispenser handle to extrude a small amount ofmaterial from the two openings at the end ofcartridge. Make sure that base and catalystcome out evenly.4. Align the V-shaped notch on the rim of mixingtip to the V-shaped notch between the cartridgebarrels. Push firmly to attach the mixing tip.Then rotate the colored collar of the mixing tip1/4 turn clockwise to the end of the cartridge.The dispenser is now ready for use.5. Squeeze the handle several times to extrudethe material. After use, do not remove the mixingtip as this will become the storage cap until nextuse. When replacing the mixing tip, rotate thecollar on the mixing tip 1/4 turn anti-clockwise toalign the V-shaped notch on the cartridge. Tiltthe mixing tip downward and peel it away fromthe cartridge.6. Remove and replace the old mixing tipimmediately prior to next use. Before attaching anew tip, gently extrude a small amount ofmaterial to ensure that base and catalyst areflowing evenly from both openings. If thematerials should fail to extrude, remove anyhardened materials from the end of thecartridge.7. To replace the cartridge, lift the release leverand retract the piston plunger fully. Remove theempty cartridge by lifting the cartridge holderand load a new one into the dispenser.USING THE IMPRESSION MATERIALNote: Prior to use, leave the material to stand atroom temperature. Cooled or refrigeratedmaterial may delay setting.
	1. Attach an intraoral tip to the mixing tip or loadmaterial 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 loadmaterial 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 withinspecified 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 withinspecified 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.
TechnologicalCharacteristics	The curing mechanism is described as anaddition silicone reaction. It is an additionpolymerization between vinyl polysiloxanes andpoly-me,-siloxanes hydrogen terminated. Aplatinum complex is used as a catalyst. A sidereaction may occur and release small quantity ofhydrogen gas. Therefore, palladium is used as ascavenger. A surfactant is added to allowwettability/hydrophilicity.Setting for AIM2 is 3 minutes in the mouth.Results of benchtop testing indicate the physicalproperties such as linear dimensional change,elastic recover and strain-in compression metthe specification set in ISO 4823.Biological safety test data shows thebiocompatibility of the predicate device.	The curing mechanism is described as anaddition silicone reaction. It is an additionpolymerization between vinyldimethylpolysiloxane and methylhydrogendimethylpolysiloxane. A platinum complex isused as a catalyst. A surfactant is added to allowwettability/hydrophilicity.Setting time for Examix is 4 minutes in themouth.Results of benchtop testing indicate the physicalproperties such as linear dimensional change,elastic recovery and strain-in compression meetthe specification set in ISO 4823.Biological safety test data shows thebiocompatibility 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).

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).