GC Temp PRINT is 3D printable light curing composite for temporary crown and bridge. The device consists of a paste delivered in a bottle. GC Temp PRINT is fabricated with certain Digital Light Processing/Stereolithography Apparatus (DLP/SLA)a` 3D printers and post cured with light curing device into dental restorations, which are then bonded to tooth structure with adhesive temporary cement.

AI/ML Overview

The provided text is a 510(k) summary for a dental device called "GC Temp PRINT". This document primarily focuses on establishing substantial equivalence to predicate devices, rather than describing a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, the requested information regarding acceptance criteria and performance study for AI/ML aspects cannot be fully provided from the given document as it refers to material properties and biocompatibility, not AI/ML performance.

However, I can extract the acceptance criteria and the bench test results for the physical properties of the GC Temp PRINT device as described in Section 6, "Performance Bench Tests".

1. Table of Acceptance Criteria and Reported Device Performance

Property	Standards	Acceptance Criteria (Requirements in ISO 10477:2018 and/or Company specification)	Reported Device Performance (Implied "Compliance")
Depth of cure	Company specification (1AB-1500-3-10696(3))	0.098 – 0.130 mm	Complies
Flexural strength	ISO 10477: 2018 5.4 Flexural strength (Fabricated by 3D Printer)	> 50 MPa	Complies
Water sorption	ISO 10477: 2018 5.6 Water sorption (Fabricated by 3D Printer)	< 40 µg/mm³	Complies
Solubility	ISO 10477: 2018 5.7 solubility (Fabricated by 3D Printer)	< 7.5 µg/mm³	Complies

Regarding the AI/ML-specific questions (2-9), the provided document does not contain this information as it describes a physical material, not an AI/ML device.

Here's why each AI/ML question cannot be answered:

2. Sample size used for the test set and the data provenance: Not an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for material property testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for material property testing.
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: Not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for material properties is defined by established international standards (ISO) and company specifications, measured objectively.
8. The sample size for the training set: Not an AI/ML device, so no training set.
9. How the ground truth for the training set was established: Not an AI/ML device, so no training set with ground truth.

Summary

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Image /page/0/Picture/0 description: The image contains 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 it.

July 9, 2020

GC America Inc. Mark Heiss Director, Regulatory & Academic Affairs 3737 W. 127th Street Alsip, Illinois 60803

Re: K193113

Trade/Device Name: GC Temp PRINT Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: June 11, 2020 Received: June 12, 2020

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. 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.

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

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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 medical devices and radiation-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,

For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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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)

K193113

Device Name GC Temp PRINT

Indications for Use (Describe)

Fabrication of temporary crowns, bridges, inlays, onlays and veneers
Fabrication of long-term temporary restorations

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

Z Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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FORM FDA 3881 (7/17)

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Image /page/3/Picture/0 description: The image shows the text 'GC' in a stylized, teal-colored font. The text is surrounded by single quotation marks on both sides. The font appears to be bold and slightly italicized, giving it a dynamic and modern look. The background is plain white, which makes the teal text stand out.

Image /page/3/Picture/1 description: The image shows a stylized number 7 with a pattern of small, teal rectangles to the right of the number. The number 7 is drawn with a thin, light blue-gray line. The rectangles are arranged in a scattered, somewhat diagonal pattern, suggesting a design element rather than a representation of a specific object.

1 Section 5 - 510(k) Summary

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) 925-0373
Date Prepared:	July 9, 2020
Device Name:
Proprietary Name:	GC Temp PRINT
Classification Name:	Temporary crown and bridge resin
Device Classification:	Class II, 872.3770
Product Code:	EBG
510(k) Number:	K193113

510(k) Number: 3. Predicate Devices:

Product	Applicant	510(k) No.	Code No	Predicate	Decision Date
Resin forTemporaryCrown & Bridge	Dentis Co., Ltd.	K180657	EBG	PrimaryPredicate	12/07/2018
TEMPSMART(MSN-006)	GC America Inc.	K141562	EBG	ReferenceDevice	09/05/2014

Description of Device: 4.

న్. GC Temp PRINT is 3D printable light curing composite for temporary crown and bridge. The device consists of a paste delivered in a bottle. GC Temp PRINT is fabricated with certain Digital Light Processing/Stereolithography Apparatus (DLP/SLA)a` 3D printers and post cured with light curing device into dental restorations, which are then bonded to tooth structure with adhesive temporary cement.
GC Temp PRINT Package: Bottle (500 g) -QTY: 1

Shades available: Light, Medium and Bleach

Shelf Life and Storage Conditions:

Shelf Life 2 years

Recommended for optimal performance, store in a cool and dark place (4-25°C / 39.2-77.0°F) away from high temperatures or direct sunlight.

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6. Performance Bench Tests

It is confirmed that the device conforms to the required specifications and is suitable for its intended use. Performance testing includes:

. Depth of cure
Flexural strength .
. Water sorption
o Solubility

The applicant device complies with some requirements of ISO 10477 and Company specification (1AB-1500-3-10696(3)). (see table below).

	Property	Standards	Requirements in ISO 10477:2018 and/or Companyspecification(1AB-1500-3-10696(3))
1	Depth of cure	Company specification (1AB-1500-3-10696(3))	0.098 – 0.130 mm
2	Flexural strength	ISO 10477: 20185.4 Flexural strength (Fabricated by 3D Printer)	> 50 MPa
3	Water sorption	ISO 10477: 20185.6 Water sorption (Fabricated by 3D Printer)	< 40 µg/mm3
4	Solubility	ISO 10477: 20185.7 solubility (Fabricated by 3D Printer)	< 7.5 µg/mm3

7. Non-Clinical Performance Testing

A biocompatibility assessment was completed according to ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Based on the criteria of the protocol and the ISO 10993-5 guidelines, the test article meets the requirements of the test and is not considered to have a cytotoxic effect.

8. Clinical Performance Testing

No clinical testing has been performed on this device.

9. Substantial equivalence

Both applicant and primary predicate device are categorized in same Code No. EBG and both curing mechanism are polymerization of uncured methacrylate oligomers. The products are a liquid photocurable material that is polymerized by UV laser. Though primary predicate device reacts with UV light 405nm, the applicant device can be polymerized by UV light which is 405nm or shorter wavelength. After printing, both applicant and primary predicate device are treated by extra light curing in UV light box to make final polymerization.

Therefore, the new and predicate devices are the same in clinical function, and similar in composition and intended use. This supports that the compatibility and safety of the applicant device are substantially equivalent to the predicate device.

10. Differences

The following differences may be noted between the predicate device and GC Temp PRINT.

Though primary predicate device indicates "Duration is less than 30 days in oral environment", applicant device is for "long-term temporary restorations".
The chemical formula is not exactly the same between applicant device and predicate devices.
2

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	Applicant device	Primary Predicate Device	Reference Device
Productcategory	Light cured temporary crown and bridgeresin,Class II872.3770; EBG	Resin for temporary crown and bridgeClass II872.3770; EBG	Dual cured temporary crown and bridge resinClass II872.3770; EBG
Trade name	GC Temp PRINT	Resin for Temporary Crown & Bridge(K180657)	TEMPSMART(MSN-006) K141562
Manufacturer	GC Manufacturing Europe N.V.	Dentis Co., Ltd.	GC Corporation
Indication foruse	1. Fabrication of Temporary crowns,bridges, inlays, onlays and veneers.2. Fabrication of long-term temporaryrestorations.	Resin for Temporary Crown & Bridge is indicatedfor the fabrication of temporary dentalrestorations in conjunction with extra-oral curinglight equipment. Duration is less than 30 days inoral environment.	1. Fabrication of temporary crowns, bridges,inlays, onlays and veneers2. Fabrication of long-term temporaryrestorations.
Productdescription	GC Temp PRINT is 3D printable lightcuring composite for temporary crownand bridge. The device consists of apaste delivered in a bottle. GC TempPRINT is fabricated with certain DigitalLight Processing/StereolithographyApparatus (DLP/SLA)a` 3D printers andpost cured with light curing device intodental restorations, which are thenbonded to tooth structure with adhesivetemporary cement.	The Resin for Temporary Crown & Bridge ismade by Methacrylate Oligomer based on theUrethane Acrylate Oligomer with 0.01~0.1wt%inorganic filler. It has stored in a brown 1000mlof HDPE bottle. It contains materials with colorsof A2 based on the shade guide. This Productis a liquid photo-curable material that ispolymerized by UV laser at 405nm. It can beused to make a tooth model with a photo-curable polymer that is cured by ultraviolet light.The liquid UV curing resin is cured at a specificwavelength (405nm) by the photo-initiatorcontained in the resin. Curing in a 3D printer isrelated to the conditions of the printerequipment, and is typically 0.1 to 0.010mm inthickness, and is output at a resolution of 0.1 to0.03 mm on the x, y axis. This device shoulduse ZENITH 3D Printer equipment using UVlight source of Dentis Co., Ltd., and it ispossible to produce three dimensional printedmatter by curing lamination step by step athicknesses of 100, 50 and 16μm.	TEMPSMART is a dual-cured, temporary crownand bridge resin. The components consist ofPaste A and B, which are filled in a cartridge.Both pastes are automixed with a mixing tip.
Components	Urethane dimethacrylate (UDMA)DimethacrylateSilicon dioxideInitiator*Pigment	The Resin for Temporary Crown & Bridge ismade by Methacrylate Oligomer based on theUrethane Acrylate Oligomer with 0.01~0.1wt%inorganic filler.	* Composite filler* Urethane dimethacrylate (UDMA)* Dimethacrylate* Silicon dioxide* Initiator* Pigment

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			* Urethane dimethacrylate (UDMA)* Dimethacrylate* Silicon dioxide* Initiator
Instructionsfor use	Manufacturing process dentalprostheticsPlease refer to respective instructions ofthe additive manufacturing systems. Listof additive manufacturing systemswhich support GC Temp PRINT can bedownloaded from GC website -www.gceurope.com1. Digital Data DesigningUse the instructed software related tothe additive manufacturing system tomodify and distribute the printed objectand support structures on the virtualbuilding platform. Create slice data with50 µm and send it to the additivemanufacturing device.Note:· Select the proper print program forGC Temp PRINT including all relevantprocess parameters.2. Print processingBefore pouring GC Temp PRINT intothe reservoir of the additivemanufacturing device, shake the GCTemp PRINT in the original bottle forapproximately 2 minutes. After shaking,directly pour it into the reservoir and setboth the reservoir and the platform inaccordance with the additivemanufacturing system instruction.Start printing.Note:Make sure your printing platform,reservoir, working space and device arecleaned properly according to theadditive manufacturing systeminstructions. Dirty tools can causedefect and therefore failure of theprinted restoration(s).	Indication for Use The Resin for TemporaryCrown & Bridge and the predicate device havesimilar indications for use statements. Limitationon the duration of the subject device wasintended to ensure the performance of subjectdevice by narrowing down the allowed terms ofits prosthetic use. Such difference is not criticalto the intended use of the subject device.Therefore it doesn't affect the safety andeffectiveness of the device when used aslabeled.	Fabricating temporary restorations1. Taking an impression1) Take an impression using alginate or siliconeimpression material. Alternatively, temporarycan be made using a laboratory-preparedthermoforming matrix.2) Block out preparation undercuts.2. Teeth preparation1) Block out preparation undercuts.2) Clean teeth preparation with water spray andlightly dry.3) Lightly lubricate separating medium such asVaseline on prepared teeth or resin core.3. Dispensing1) Before dispensing the first time from a newsyringe or after a long interval in between use,bleed the pastes from the syringe.2) Remove the cap of the syringe by rotating 1/4turn anti-clockwise. Attach a Mixing Tip byaligning the V shaped notch on the rim of themixing tip with the V shaped notch between thesyringe barrels. Push firmly to attach the mixingtip. Then rotate the colored collar of the mixingtip 1/4 turn clockwise.3) Discard first cm extruded before use.4) Extrude material directly into the impression.NOTE:The used mixing tip can be left on the syringe toserve as a storage cap until next use. For eachapplication, place a new mixing tip.4. Fabricating a temporary restorationFabricate a temporary crown and bridgeaccording to timing showed below. Timeindicate after start of mixing paste.Option1 Fabricating in the mouth

기

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• Color difference may occur if shaking is insufficient.• Avoid cross contamination with other products.• Before each printing process, gently stir the remaining material in the reservoir.Before each printing process, check there is no polymerized area or visual evidence of contamination. If such, replace material.• Replace material in the reservoir according the additive manufacturing system instructions.3. Cleaning of the printed objectsCarefully remove the printed restoration(s) from the printing platform.Do not remove the support structures under the object. For Cleaning, place the restoration(s) in a glass with Isopropanol solution (>96%), then place the glass in an ultrasonic water bath for 2min. Dry parts with compressed air.Repeat the cleaning procedure in a clean Isopropanol solution (>96%), then place in an ultrasonic water bath for 2 min. Important that the second rinse is done in a clean Isopropanol solution.After cleaning, check if the surface is still shiny, wet or sticky, which would indicate there is still Isopropanol or residual monomers on the printed object. If such, please repeat the cleaning procedure until restoration(s) are completely clean.Note:• Do not rinse the restoration in an Isopropanol solution for more than 5 min.• Do not wipe the restoration(s) surface.• After cleaning, check the restoration for:o Inhomogeneous color distribution linked to the printing processo Deformation	0'00"~~1'00" Place TEMPSMART into the impression and reposition into the mouth.1'00"~~2'00" Setting in the mouth.Up to2'00" Remove the impression from the teeth.If necessary, tack cure with a light curing unit (GC G-Light) for 2seconds each tooth unit on the teeth.Remove the temporary restoration from the mouth and final cure with light curing unit for 5seconds each tooth unit.Afterfinal Completely remove the oxygen inhibition layer from the surface of the temporary restoration with alcohol.cureOption2 Fabricating on the model0'00"~~1'00" Place TEMPSMART into the impression and reposition on the model.1'00"~~3'00" Setting on the model.Up to3'00" Remove the impression from the model.Remove the impression from the model and final cure with an extraoral light curing oven for 1minute.Remove the temporary restoration from the model.Afterfinal Completely remove the oxygen inhibition layer from surface of the temporary restoration with alcohol.cureCaution!When using a light curing unit on teeth, do not irradiate the temporary restoration more than 2 seconds for each surface because of high polymerization temperature.Note:
o Defects like cracks or holes4. Post curingPerform a final polymerization usingLabolight DUO. For use of otherdevices, we refer to respectiveinstructions manufacturing systemswhich support GC Temp PRINT. This listcan be downloaded from GC website -www.gceurope.comFor final polymerization with LabolightDUO, cure for 3min on opposite fromsupport side.Remove supports with a nipper and acarbide bur.Apply light for another 3 min from theother side to obtain final homogeneouspolymerization. When using othermanufacturers' light curing devices,refer to the respective manufacturer'sinstructions for use.Note:• Make sure the Isopropanol solution iscompletely removed prior to post curing.• Do not apply light curing longer thaninstructed.• Do not use chair side hand-held typecuring light for post curing.• Do not store the printed restoration(s)in direct sunlight.5. Adjustment - Finishing - Gloss1. Carefully remove the remainingsupports with a carbide bur. Too muchpressure could break the restoration(s).2. Shape and finish in the usual way.3. When necessary, minor fitadjustments can be undertaken usingUNIFAST III.4. If required, modify shape by using aresin material such as G-aenial Flo X,G-aenial Universal Flo, UNIFAST III orgrind to obtain proper occlusion.5. Apply a coating agent OPTIGLAZEcolor following the manufacturer'sinstructions for use.Note:	1) The above processing times are applicable toproducts which have been stored andprocessed at a temperature of 23° C / 74° F andat 50% relative humidity. Higher temperaturesshorten these times, while lower temperaturesextend them. The size of the restoration alsohas an impact on the setting times: as the sizeof the workpiece increases, the settingaccelerates.2) When light irradiating to the temporarybridge, irradiate the light onto the occlusalsurface.3) When final curing the temporary bridge with alight curing unit, irradiate the light by one toothfrom both ends to of prevent deformation.5. Finishing1) Remove the excess material using a finecarbide bur.2) Check occlusion and if necessary, correctshape by using a resin material (TEMPSMART,G-ænial Flo, G-ænial Universal Flo, UNIFASTTrad) or grind to obtain proper occlusion.3) Polish the surface of the temporaryrestoration using silicon polisher and goat's hairwheel. Alternatively, apply a coating agent(OPTIGLAZE).Caution!Do not breathe in polishing dust. Use personalprotective devices such as facemask and safetyglasses.Note:1) When using a resin material (TEMPSMART,G-ænial Flo, G-ænial Universal Flo, UNIFASTTrad) for custom-shaping and shape correction,there usually is no need for a bonding agent.But completely remove saliva contaminated partusing a carbide bur. And if necessary, apply aceramic primer (CERAMIC PRIMER II) to thesurface of the temporary restoration.2) When using TEMPSMART for custom-shaping and shape correction, light cure themixing paste with a light curing unit for 10seconds.

• Color difference may occur if shaking is insufficient.• Avoid cross contamination with other products.• Before each printing process, gently stir the remaining material in the reservoir.Before each printing process, check there is no polymerized area or visual evidence of contamination. If such, replace material.• Replace material in the reservoir according the additive manufacturing system instructions.3. Cleaning of the printed objectsCarefully remove the printed restoration(s) from the printing platform.Do not remove the support structures under the object. For Cleaning, place the restoration(s) in a glass with Isopropanol solution (>96%), then place the glass in an ultrasonic water bath for 2min. Dry parts with compressed air.Repeat the cleaning procedure in a clean Isopropanol solution (>96%), then place in an ultrasonic water bath for 2 min. Important that the second rinse is done in a clean Isopropanol solution.After cleaning, check if the surface is still shiny, wet or sticky, which would indicate there is still Isopropanol or residual monomers on the printed object. If such, please repeat the cleaning procedure until restoration(s) are completely clean.Note:• Do not rinse the restoration in an Isopropanol solution for more than 5 min.• Do not wipe the restoration(s) surface.• After cleaning, check the restoration for:o Inhomogeneous color distribution linked to the printing processo Deformation

0'00"~~1'00" Place TEMPSMART into the impression and reposition into the mouth.1'00"~~2'00" Setting in the mouth.Up to2'00" Remove the impression from the teeth.If necessary, tack cure with a light curing unit (GC G-Light) for 2seconds each tooth unit on the teeth.Remove the temporary restoration from the mouth and final cure with light curing unit for 5seconds each tooth unit.Afterfinal Completely remove the oxygen inhibition layer from the surface of the temporary restoration with alcohol.cureOption2 Fabricating on the model0'00"~~1'00" Place TEMPSMART into the impression and reposition on the model.1'00"~~3'00" Setting on the model.Up to3'00" Remove the impression from the model.Remove the impression from the model and final cure with an extraoral light curing oven for 1minute.Remove the temporary restoration from the model.Afterfinal Completely remove the oxygen inhibition layer from surface of the temporary restoration with alcohol.cureCaution!When using a light curing unit on teeth, do not irradiate the temporary restoration more than 2 seconds for each surface because of high polymerization temperature.Note:

o Defects like cracks or holes4. Post curingPerform a final polymerization usingLabolight DUO. For use of otherdevices, we refer to respectiveinstructions manufacturing systemswhich support GC Temp PRINT. This listcan be downloaded from GC website -www.gceurope.comFor final polymerization with LabolightDUO, cure for 3min on opposite fromsupport side.Remove supports with a nipper and acarbide bur.Apply light for another 3 min from theother side to obtain final homogeneouspolymerization. When using othermanufacturers' light curing devices,refer to the respective manufacturer'sinstructions for use.Note:• Make sure the Isopropanol solution iscompletely removed prior to post curing.• Do not apply light curing longer thaninstructed.• Do not use chair side hand-held typecuring light for post curing.• Do not store the printed restoration(s)in direct sunlight.5. Adjustment - Finishing - Gloss1. Carefully remove the remainingsupports with a carbide bur. Too muchpressure could break the restoration(s).2. Shape and finish in the usual way.3. When necessary, minor fitadjustments can be undertaken usingUNIFAST III.4. If required, modify shape by using aresin material such as G-aenial Flo X,G-aenial Universal Flo, UNIFAST III orgrind to obtain proper occlusion.5. Apply a coating agent OPTIGLAZEcolor following the manufacturer'sinstructions for use.Note:

1) The above processing times are applicable toproducts which have been stored andprocessed at a temperature of 23° C / 74° F andat 50% relative humidity. Higher temperaturesshorten these times, while lower temperaturesextend them. The size of the restoration alsohas an impact on the setting times: as the sizeof the workpiece increases, the settingaccelerates.2) When light irradiating to the temporarybridge, irradiate the light onto the occlusalsurface.3) When final curing the temporary bridge with alight curing unit, irradiate the light by one toothfrom both ends to of prevent deformation.5. Finishing1) Remove the excess material using a finecarbide bur.2) Check occlusion and if necessary, correctshape by using a resin material (TEMPSMART,G-ænial Flo, G-ænial Universal Flo, UNIFASTTrad) or grind to obtain proper occlusion.3) Polish the surface of the temporaryrestoration using silicon polisher and goat's hairwheel. Alternatively, apply a coating agent(OPTIGLAZE).Caution!Do not breathe in polishing dust. Use personalprotective devices such as facemask and safetyglasses.Note:1) When using a resin material (TEMPSMART,G-ænial Flo, G-ænial Universal Flo, UNIFASTTrad) for custom-shaping and shape correction,there usually is no need for a bonding agent.But completely remove saliva contaminated partusing a carbide bur. And if necessary, apply aceramic primer (CERAMIC PRIMER II) to thesurface of the temporary restoration.2) When using TEMPSMART for custom-shaping and shape correction, light cure themixing paste with a light curing unit for 10seconds.

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: :

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	· Do not use GC Temp PRINT as anadd on material.When using a resin material such as G-aenial Flo X, G-aenial Universal Flo orUNIFAST III for custom-shaping andshape correction, there is norequirement for prior application of abonding agent.6. CementingCement the completed temporaryrestoration using FREEGENOL orequivalent temporary cement.		6. CementingCement using temporary cement.Note:Do not use eugenol cement because it willprevent polymerization of resin.Repairing / Modifying of temporary restorations1) Abrade the surface of the temporaryrestorations using carbide bur.2) If necessary, apply a ceramic primer(CERAMIC PRIMER II) and dry with air.3) Place a resin material (TEMPSMART, G-ænial Flo, G-ænial Universal Flo, UNIFASTTrad) and cure according to manufacturer'sinstructions.Note:Completely remove saliva contaminated partusing a carbide bur.
TechnologicalCharacteristicsand Mode ofaction	The curing mechanism ispolymerization of uncured methacrylateester monomers photo initiator. It isfabricated by using Additivemanufacturing system (3D printer).	The subject device is a polymer that changes itsproperties when exposed to UV light. It conformsinto a hardened polymeric material through aprocess called curing. Temporary dentalrestoration using resin is technologically usefulapplications for dental treatment.	The curing mechanism is polymerization ofuncured methacrylate ester monomers by"mixing initiator(s) and activator(s)" and/or"photo initiator." It is fabricated manually.

10. Conclusion

Based on similarities in intended use, mode of action, chemical composition, and performance testing, CC Temp PRINT is substantially equivalent to the selected predicate devices.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.