(240 days)
No
The summary describes a 3D printable material for temporary dental restorations and does not mention any AI or ML components in its fabrication or function.
No
This device is a material (3D printable light curing composite) used to fabricate temporary dental restorations, not a therapeutic device itself. Its purpose is to physically replace missing tooth structure.
No
The device is described as a 3D printable light-curing composite for temporary dental restorations. Its intended use is fabrication, not diagnosis. It does not analyze patient data or provide diagnostic information.
No
The device description clearly states it is a "3D printable light curing composite for temporary crown and bridge" delivered as a "paste delivered in a bottle." This is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the fabrication of temporary dental restorations (crowns, bridges, inlays, onlays, veneers). This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description details a material used to create physical dental devices. It doesn't mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the material (depth of cure, flexural strength, water sorption, solubility) and biocompatibility, which are relevant for a restorative material, not a diagnostic device.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Fabrication of temporary crowns, bridges, inlays, onlays and veneers
- Fabrication of long-term temporary restorations
Product codes
EBG
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The device conforms to the required specifications and is suitable for its intended use based on performance testing which includes: Depth of cure, Flexural strength, Water sorption, and Solubility. The applicant device complies with some requirements of ISO 10477 and Company specification (1AB-1500-3-10696(3)). A biocompatibility assessment was completed according to ISO 10993-1:2009 and ISO 10993-5 guidelines, concluding no cytotoxic effect. No clinical testing has been performed on this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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
1
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
2
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)
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:
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 fo, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
3
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
-
- 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 for | |||||
| Temporary | |||||
| Crown & Bridge | Dentis Co., Ltd. | K180657 | EBG | Primary | |
| Predicate | 12/07/2018 | ||||
| TEMPSMART | |||||
| (MSN-006) | GC America Inc. | K141562 | EBG | Reference | |
| Device | 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.
4
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 Company
specification
(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: 2018
5.4 Flexural strength (Fabricated by 3D Printer) | > 50 MPa |
| 3 | Water sorption | ISO 10477: 2018
5.6 Water sorption (Fabricated by 3D Printer) |
- Composite filler
- Urethane dimethacrylate (UDMA)
- Dimethacrylate
- Silicon dioxide
- Initiator
- Pigment |
6
| | | |
- Urethane dimethacrylate (UDMA)
- Dimethacrylate
- Silicon dioxide
- Initiator |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Instructions
for use | Manufacturing process dental
prosthetics
Please refer to respective instructions of
the additive manufacturing systems. List
of additive manufacturing systems
which support GC Temp PRINT can be
downloaded from GC website -
www.gceurope.com
- Digital Data Designing
Use the instructed software related to
the additive manufacturing system to
modify and distribute the printed object
and support structures on the virtual
building platform. Create slice data with
50 µm and send it to the additive
manufacturing device.
Note:
· Select the proper print program for
GC Temp PRINT including all relevant
process parameters. - Print processing
Before pouring GC Temp PRINT into
the reservoir of the additive
manufacturing device, shake the GC
Temp PRINT in the original bottle for
approximately 2 minutes. After shaking,
directly pour it into the reservoir and set
both the reservoir and the platform in
accordance with the additive
manufacturing system instruction.
Start printing.
Note:
Make sure your printing platform,
reservoir, working space and device are
cleaned properly according to the
additive manufacturing system
instructions. Dirty tools can cause
defect and therefore failure of the
printed restoration(s). | Indication for Use The Resin for Temporary
Crown & Bridge and the predicate device have
similar indications for use statements. Limitation
on the duration of the subject device was
intended to ensure the performance of subject
device by narrowing down the allowed terms of
its prosthetic use. Such difference is not critical
to the intended use of the subject device.
Therefore it doesn't affect the safety and
effectiveness of the device when used as
labeled. | Fabricating temporary restorations - Taking an impression
- Take an impression using alginate or silicone
impression material. Alternatively, temporary
can be made using a laboratory-prepared
thermoforming matrix. - Block out preparation undercuts.
- Teeth preparation
- Block out preparation undercuts.
- Clean teeth preparation with water spray and
lightly dry. - Lightly lubricate separating medium such as
Vaseline on prepared teeth or resin core.
- Dispensing
- Before dispensing the first time from a new
syringe or after a long interval in between use,
bleed the pastes from the syringe. - Remove the cap of the syringe by rotating 1/4
turn anti-clockwise. Attach a Mixing Tip by
aligning the V shaped notch on the rim of the
mixing tip with the V shaped notch between the
syringe barrels. Push firmly to attach the mixing
tip. Then rotate the colored collar of the mixing
tip 1/4 turn clockwise. - Discard first cm extruded before use.
- Extrude material directly into the impression.
NOTE:
The used mixing tip can be left on the syringe to
serve as a storage cap until next use. For each
application, place a new mixing tip.
- Fabricating a temporary restoration
Fabricate a temporary crown and bridge
according to timing showed below. Time
indicate after start of mixing paste.
Option1 Fabricating in the mouth |
기
7
| • 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 objects
Carefully 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 process
o Deformation | 0'00"~
1'00" Place TEMPSMART into the impression and reposition into the mouth.
1'00"~
2'00" Setting in the mouth.
Up to
2'00" 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.
After
final Completely remove the oxygen inhibition layer from the surface of the temporary restoration with alcohol.
cure
Option2 Fabricating on the model
0'00"~
1'00" Place TEMPSMART into the impression and reposition on the model.
1'00"~
3'00" Setting on the model.
Up to
3'00" 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.
After
final Completely remove the oxygen inhibition layer from surface of the temporary restoration with alcohol.
cure
Caution!
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 holes
4. Post curing
Perform a final polymerization using
Labolight DUO. For use of other
devices, we refer to respective
instructions manufacturing systems
which support GC Temp PRINT. This list
can be downloaded from GC website -
www.gceurope.com
For final polymerization with Labolight
DUO, cure for 3min on opposite from
support side.
Remove supports with a nipper and a
carbide bur.
Apply light for another 3 min from the
other side to obtain final homogeneous
polymerization. When using other
manufacturers' light curing devices,
refer to the respective manufacturer's
instructions for use.
Note:
• Make sure the Isopropanol solution is
completely removed prior to post curing.
• Do not apply light curing longer than
instructed.
• Do not use chair side hand-held type
curing light for post curing.
• Do not store the printed restoration(s)
in direct sunlight.
5. Adjustment - Finishing - Gloss
- Carefully remove the remaining
supports with a carbide bur. Too much
pressure could break the restoration(s). - Shape and finish in the usual way.
- When necessary, minor fit
adjustments can be undertaken using
UNIFAST III. - If required, modify shape by using a
resin material such as G-aenial Flo X,
G-aenial Universal Flo, UNIFAST III or
grind to obtain proper occlusion. - Apply a coating agent OPTIGLAZE
color following the manufacturer's
instructions for use.
Note: | 1) The above processing times are applicable to
products which have been stored and
processed at a temperature of 23° C / 74° F and
at 50% relative humidity. Higher temperatures
shorten these times, while lower temperatures
extend them. The size of the restoration also
has an impact on the setting times: as the size
of the workpiece increases, the setting
accelerates.
- When light irradiating to the temporary
bridge, irradiate the light onto the occlusal
surface. - When final curing the temporary bridge with a
light curing unit, irradiate the light by one tooth
from both ends to of prevent deformation.
- Finishing
- Remove the excess material using a fine
carbide bur. - Check occlusion and if necessary, correct
shape by using a resin material (TEMPSMART,
G-ænial Flo, G-ænial Universal Flo, UNIFAST
Trad) or grind to obtain proper occlusion. - Polish the surface of the temporary
restoration using silicon polisher and goat's hair
wheel. Alternatively, apply a coating agent
(OPTIGLAZE).
Caution!
Do not breathe in polishing dust. Use personal
protective devices such as facemask and safety
glasses.
Note:
- When using a resin material (TEMPSMART,
G-ænial Flo, G-ænial Universal Flo, UNIFAST
Trad) for custom-shaping and shape correction,
there usually is no need for a bonding agent.
But completely remove saliva contaminated part
using a carbide bur. And if necessary, apply a
ceramic primer (CERAMIC PRIMER II) to the
surface of the temporary restoration. - When using TEMPSMART for custom-
shaping and shape correction, light cure the
mixing paste with a light curing unit for 10
seconds. |
8
D
: :
.
T
9
| | · Do not use GC Temp PRINT as an
add on material.
When using a resin material such as G-
aenial Flo X, G-aenial Universal Flo or
UNIFAST III for custom-shaping and
shape correction, there is no
requirement for prior application of a
bonding agent.
6. Cementing
Cement the completed temporary
restoration using FREEGENOL or
equivalent temporary cement. | | 6. Cementing
Cement using temporary cement.
Note:
Do not use eugenol cement because it will
prevent polymerization of resin.
Repairing / Modifying of temporary restorations
- Abrade the surface of the temporary
restorations using carbide bur. - If necessary, apply a ceramic primer
(CERAMIC PRIMER II) and dry with air. - Place a resin material (TEMPSMART, G-
ænial Flo, G-ænial Universal Flo, UNIFAST
Trad) and cure according to manufacturer's
instructions.
Note:
Completely remove saliva contaminated part
using a carbide bur. |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics
and Mode of
action | The curing mechanism is
polymerization of uncured methacrylate
ester monomers photo initiator. It is
fabricated by using Additive
manufacturing system (3D printer). | The subject device is a polymer that changes its
properties when exposed to UV light. It conforms
into a hardened polymeric material through a
process called curing. Temporary dental
restoration using resin is technologically useful
applications for dental treatment. | The curing mechanism is polymerization of
uncured 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.
: