GRADIA PLUS is a dental composite consisting of cross-linked polymeric material reinforced by a dispersion of filler particles bonded to the resin matrix. The product contains a photo initiator to allow for curing/conversion. The end result is a conversion from a paste to a hard solid material. GRADIA PLUS is composed of 4 types of pastes, such as Opaque paste, Gum shade paste and Lustre paint. Opaque paste is used for masking the metal color. Body paste has two different consistencies. Paste HB and Paste LB. Both pastes can be used for creating several types of anterior or posterior restorations. There are several shades for dentin shade, Enamel shade and effect shade. The dentin layers have an enhanced brightness and masking ability that adjusts the opalescence of the composites. This gives a bright color tone in the oral cavity and eliminates unnatural translucency at the incisal edge. In addition, it has several red colors as a Gum shade paste with different transparency and color tone for reproducing of gingival tissue over crown. Lustre Paint is used for staining, characterizing and coating. The device is used for crown and bridgework with metal backing, jacket crowns, inlays, veneers, implant super structures and reproduction of gum tissue for crown restorations. In particular, Gradia Plus is intended to fabricate the tertiary element/exostructure of the implant superstructure, such as crown and bridges. GRADIA PLUS is filled in a syringe and is available in 73 shades.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for "GRADIA PLUS":

The document is a 510(k) premarket notification clearance letter from the FDA to GC America Inc. for their dental composite device, GRADIA PLUS. It primarily focuses on establishing substantial equivalence to predicate devices, rather than an independent clinical study demonstrating device performance against specific disease-related acceptance criteria.

Key Observation: This document describes a material science device (dental composite) and its bench testing to ensure it meets material property standards (ISO). It is not a diagnostic AI device, and therefore the typical questions about ground truth, expert readers, MRMC studies, or standalone algorithm performance are not applicable in this context. The "acceptance criteria" here refer to conformance with established material standards and the "study" is a series of bench tests.

Acceptance Criteria and Device Performance

Acceptance Criteria (ISO 10477:2004 and company standards)	Reported Device Performance
Sensitivity to ambient light	Conforms to required specifications
Depth of cure	Conforms to required specifications
Surface finish	Conforms to required specifications
Flexural strength	Conforms to required specifications (also compared to predicates for equivalence)
Water sorption	Conforms to required specifications (also compared to predicates for equivalence)
Solubility	Conforms to required specifications (also compared to predicates for equivalence)
Shade consistency	Conforms to required specifications
Color stability	Conforms to required specifications
Overall Stability of Materials in Oral Environment	Shows equivalence in flexural strength, water sorption, and solubility (compared to predicates)

Note: The document states, "It is confirmed that the device conforms to the required specifications of ISO 10477:2004 and company standard are suitable for its intended use." It also mentions "shows equivalence in flexural strength, water sorption and solubility" when comparing to predicate devices. Specific quantitative values for the reported device performance are not provided in this document, only a statement of conformance.

Study Details (as inferable from the document)

1. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The testing would involve preparing multiple samples of the GRADIA PLUS material for each physical property test (e.g., multiple specimens for flexural strength, multiple for water sorption). The number of replicates for each test would typically follow ISO standard guidelines.
- Data Provenance: The tests are "bench tests" performed by GC America Inc. ("company standard"). The country of origin of the data is implicitly the location where GC America Inc. conducted its R&D and testing (Alsip, Illinois, USA, as per their address). The data is prospective in the sense that it was generated for the purpose of validating the new device, but it is material property testing, not clinical trial data on human subjects.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a study requiring human expert interpretation for "ground truth" as it is material science testing. The "ground truth" is derived from physical measurements against established ISO standards.
3. Adjudication method for the test set:
- Not Applicable. No human adjudication process is described or implied for these material property tests.
4. 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 Applicable. This is a dental material, not an AI diagnostic device. No human-in-the-loop or MRMC study was conducted or is relevant.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a dental material, not an AI algorithm. No standalone algorithm performance was assessed.
6. The type of ground truth used:
- The "ground truth" for the acceptance criteria is defined by established international standards (ISO 10477:2004) and internal company specifications for dental resin materials. This involves precise physical and chemical measurements rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus) relevant to diagnostic devices.
7. The sample size for the training set:
- Not Applicable. This device is a dental composite material, not a machine learning model. There is no concept of a "training set" in this context.
8. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is irrelevant.

Summary regarding the device type:

The GRADIA PLUS is a dental composite material used for restorations like crowns, bridges, inlays, onlays, and veneers, as well as gum tissue reproduction. The "study" referenced in the document is a series of performance bench tests designed to confirm that the material properties of the device conform to relevant ISO standards (ISO 10477:2004) and internal company specifications. The FDA's clearance is based on the determination of substantial equivalence to existing predicate devices, meaning it has similar indications for use, fundamental scientific technology, and performance characteristics (as demonstrated by these bench tests). The questions provided are primarily geared towards AI/ML diagnostic devices, which operate under a very different regulatory and validation framework than a material science product like this dental composite.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized image of three faces in profile, layered on top of each other, suggesting a sense of community and care. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 12, 2016

GC Americica Inc. Mark Heiss, D.D.S. Director, Regulatory and Academic Affairs 3737 W 127th Street Alsip, Illinois 60803

Re: K153325

Trade/Device Name: GRADIA PLUS Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: June 2, 2016 Received: June 3, 2016

Dear Dr. 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.

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Page 2 - Mark Heiss, D.D.S.

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

510(k) Number (if known): K153325

Device Name: GRADIA PLUS

Indications for Use:

1. Crown and Bridgework (with metal backing)
1. Metal free restorations: Jacket Crowns, Inlays, Onlays and Laminated Veneers
1. Implant superstructures
1. Reproduction of gum tissue for crown restorations

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/1 description: The image shows the letters 'CCI' in a stylized, sans-serif font. The letters are a vibrant green color, and they appear to be slightly italicized or slanted to the right. The letters are enclosed in single quotation marks.

GC AMERICA INC.
3737 WEST 127TH STREET
ALSIP, ILLINOIS 60003
TEL (708) 597-0900
FAX (708) 371-5103

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
	(708) 926-3092
Fax:	(708) 926-9100

Date Prepared: June 1, 2016

1. Device Name:

Proprietary Name:	GRADIA PLUS
Classification Name:	Tooth shade resin material
Device Classification:	Class II, 872.3690
Product Code:	EBF

3. Predicate Devices:

Company	Device	510(k) No.	Date Cleared	Predicate
GC America Inc.	GRADIA	K001518	07/05/2000	Primary
GC America Inc.	GRADIA gum shades	K033808	02/02/2004	Reference
GC America Inc.	G-aenial Sculpt (MFP-051)	K123631	07/23/2013	Reference
GC America Inc.	OPTIGLAZE color	K133836	03/06/2014	Reference

4. Description of Device:

GRADIA PLUS is composed of 4 types of pastes, such as Opaque paste, Gum shade paste and Lustre paint.

Opaque paste is used for masking the metal color.

Body paste has two different consistencies. Paste HB and Paste LB. Both pastes can be used for creating several types of anterior or posterior restorations. There are several shades for dentin shade, Enamel shade and effect shade. The dentin layers have an enhanced brightness and masking ability that adjusts the opalescence of the composites. This gives a bright color tone in the oral cavity and eliminates unnatural translucency at the incisal edge.

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In addition, it has several red colors as a Gum shade paste with different transparency and color tone for reproducing of gingival tissue over crown.

Lustre Paint is used for staining, characterizing and coating.

The device is used for crown and bridgework with metal backing, jacket crowns, inlays, veneers, implant super structures and reproduction of gum tissue for crown restorations. In particular, Gradia Plus is intended to fabricate the tertiary element/exostructure of the implant superstructure, such as crown and bridges.

GRADIA PLUS is filled in a syringe and is available in 73shades: HB-DA1, HB-DA3, HB-DA3.5, HB-DB1, HB-DB3, HB-DC3, HB-DD2, HB-DW, HB-ODA, HB-ODB, HB-ODC, HB-ODD, HB-ODW, HB-EL, HB-ED, HB-CLF, HB-PE, LB-BaseD, LB-BaseCLF, LB-BaseCLF, LB-BaseOD, LB-BaseOpal, LB-DW, LB-Orange, LB-Red, LB-Yellow, LB-Blue, LB-Grey, LB-Milky, LB-Inlay E, LB-Inlay TD, LB-A, LB-B, LB-C, LB-D, LB-W, GLB-1, GLB-2, GLB-3, GLB-CL, GHB-1, GHB-2, GHB-3, GHB-CL, O-BASE, OA, OB, OC, OD, OA1, OA2, OA3, OA3.5, OB1, OB3, OC3, OD2, GO-1, GO-2, LP-A, LP-B, LP-C, LP-D, LP-CLF, LP-Blue, LP-Cream, LP-Grey, LP-Lavender, GLP-Bright red, GLP-Violet, LP-CL

ર Performance Bench Tests

It is confirmed that the device conforms to the required specifications of ISO 10477:2004 and company standard are suitable for its intended use. Performance testing includes:

Sensitivity to ambient light ●
Depth of cure ●
Surface finish ●
Flexural strength ●
Water sorption
Solubility ●
Shade consistency ●
Color stability ●

6. Packaging

1. OPAQUE, 2.0mL syringe (in 13 shades)
- O-BASE, OA, OB, OC, OD, OA1, OA2, OA3, OA3.5, OB1, OB3, OC3, OD2
1. PASTE HB, 3.3mL syringe (in 18 shades) HB-DA1, HB-DA2, HB-DA3, HB-DA3.5, HB-DB1, HB-DB3, HB-DC3, HB-DD2, HB-DW, HB-
ODA, HB-ODB, HB-ODC, HB-ODD, HB-ODW, HB-EL, HB-ED, HB-CLF, HB-PE 3) PASTE LB, 2.0mL syringe (in 15 shades) LB-BaseD, LB-BaseE, LB-BaseCLF, LB-BaseOD, LB-BaseOpal, LB-DW, LB-ODW, LB-Orange,
LB-Red, LB-Yellow, LB-Blue, LB-Grey, LB-Milky, LB-Inlay E, LB-Inlay TD
1. ONE BODY, 2.0mL syringe (in 5 shades)
LB-A, LB-B, LB-C, LB-D, LB-W
1. GUM SHADES, 2.0mL syringe (in 10 shades)

G0-1, GO-2, GLB-1, GLB-2, GLB-3, GLB-CL, GHB-1, GHB-2, GHB-3, GHB-CL

1. LUSTRE PAINT, 0.8mL syringe (in 12 shades)
  LP-A, LP-B, LP-C, LP-D, LP-CLF, LP-Blue, LP-Cream, LP-Grey, LP-Lavender, GLP-Bright red, GLP-Violet, LP-CL

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Accessories 1) MODELING LIQUID 3mL Bottle 2) LP DILUTING LIQUID 3mL Bottle 3) AIR BARRIER 10mL Bottle 4) SEPARATOR 5mL Bottle 5) DIE-HARDNER 5mL Bottle

1. Shelf Life Evaluation and Storage Conditions:
- Shelf Life 3 years
- Recommended for optimal performance, store in a cool place (4-25℃ / 39.2-77.0 °F) away from high temperatures of direct sunlight.
1. Indications for Use:
- 1. Crown and Bridgework (with metal backing)
- 1. Metal free restorations: Jacket Crowns, Inlays, Onlays and Laminated Veneers
- 1. Implant superstructures
- 1. Reproduction of gum tissue for crown restorations
1. Technological characteristics:

All the components of the applicant device, GRADIA PLUS, have already been used in the predicate devices. GRADIA PLUS contains ultra-fine barium glass and pre-polymerized filler which exhibit wear resistance and gloss retention. The applicant device also shows equivalence in flexural strength, water sorption and solubility, which indicate the stability of materials in oral environment. The curing mechanism of the predicates and GRADIA PLUS is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator system.

10. Substantial equivalence

The curing mechanism of the new and predicate devices is substantially equivalent in principle. Therefore, the applicant and primary predicate device are the same in function, and similar in composition and intended use. This supports that the compatibility of the applicant device is substantially equivalent to the primary predicate device.

11. Differences

The following differences may be noted between the predicate device and GRADIA PLUS:
GRADIA PLUS is available in 73 shades ●
GRADIA PLUS is available in 5 types of paste: Paste HB, Paste LB, Gum Shade LB, Opaque, ● Lustre Paint (Stain)
GRADIA PLUS is used for crown and bridgework with metal backing, jacket crowns, inlays, ● onlays, veneers, implant super structures and reproduction of gum tissue for crown restorations. The difference is that Gradia is not indicated for shade reproduction of gum tissue. However, this indication is found in Gradia Gum, K033808.
. Applicant device requires coating or polishing as a surface finish. Gradia requires only polishing and Optiglaze Color requires only Coating.
Gradia uses light-cured hybrid fillers, while Gradia Plus uses light-cured nano fillers. .
. Gradia Plus has improved surface gloss which utilizes coating and polishing versus primary predicate only requiring polishing.

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	Applicant device	Primary Predicate device	Difference	Impact on Effectiveness and
Trade name	GRADIA PLUS	GRADIA	Y/N	rationale
Product category	Light-cured composite for crown and bridge	Light-cured composite for crown andbridge
Company	GC Corporation	GC Corporation
510(k) No.	K153325	K001518
Number of shades	73	137	Y	Shade number does not impacton safety or efficacy.
Indications for use	1. Crown and Bridgework (with metalbacking)2. Metal free restorations: Jacket Crowns,Inlays, Onlays and Laminated Veneers3. Implant superstructures4. Reproduction of gum tissue for crownrestorations	1. Crown and Bridgework (with metalbacking)2. Metal free restorations: JacketCrowns, Inlays, Onlays and LaminatedVeneers3. Implant superstructures	Y	Applicant device includes forreproduction of gum tissue.Comparative device does notinclude for reproduction of gumtissue.Product performs withinrequirements.
Productdescription	GRADIA PLUS is a light-cured nano-filledradiopaque composite resin filled in asyringe. The device is used for crown andbridgework with metal backing, jacketcrowns, inlays, onlays, veneers, implantsuper structures and reproduction of gumtissue for crown restorations.	GRADIA is a light-cured hybrid MFR(micro-filled-resin) hard resin forlaboratory fabrication of crown & bridge,jacket crowns, inlays, onlays andlaminated veneer restorations. Gradiacan be used for both metal free and metalbased restorations	Y	Applicant device includes forreproduction of gum tissue.Comparative device does notinclude for reproduction of gumtissue.Product performs withinrequirements.
Instructions foruse	1.Preparation2.Treatment3.Build up4.Light curing5.Glazing (Coating and Polishing)	1.Preparation2.Treatment3.Build up4.Light curing5. Polishing	Y	Applicant device requires coatingor polishing as a surface finish.Predicate device requires onlypolishing.Product performs withinrequirements.
	Applicant device	Reference Predicate device	Difference	Impact on Effectiveness
Trade name	GRADIA PLUS	GRADIA gum shades	Y/N	and rationale
Product category	Light-cured composite for crown and bridge	Light-cured gum shades compositesystem
Company	GC Corporation	GC Corporation
510(k) No.	K153325	K033808
Shade number	73	17	Y	Shade number does not impacton safety or efficacy.
Indications for use	1. Crown and Bridgework (with metalbacking)2. Metal free restorations: Jacket Crowns,Inlays, Onlays and Laminated Veneers3. Implant superstructures4. Reproduction of gum tissue for crownrestorations	GRADIA GUM is a light-cured compositeresin specifically used for thereproduction of the gum on crown andbridge prostheses.	Y	Applicant device is for crown ,inlays, onlays, veneers, Implantsuperstructure and shadereproduction of gum tissue.Comparative device is only forgum tissue, such as implantsuperstructures and removablemetal frames.Product performs withinrequirements.
Productdescription	GRADIA PLUS is a light-cured nano-filledradiopaque composite resin filled in asyringe. The device is used for crown andbridgework with metal backing, jacketcrowns, inlays, onlays, veneers, implantsuper structures and reproduction of gumtissue for crown restorations.	GRADIA gum shades is a light-curedMFR (micro-filled-resin) composite forreproduction of gum tissue for crownrestorations including implantsuperstructures and removal of metalframes. Five gum shades are availablealong with the Opaque, Translucent,Modifiers and Accessories.	Y	Applicant device is for crown,inlays, onlays, veneers, Implantsuperstructure and reproductionof gum tissue. Comparativedevice is only for gum tissue,such as implant superstructuresand removable metal frames.Product performs withinrequirements.
Instructions foruse	1.Preparation2. Treatment3.Build up4.Light curing5.Glazing (Coating and Polishing)	1.Preparation2. Treatment3.Build up4.Light curing5. Polishing	Y	Applicant device require coatingor polishing as a surface finish.Predicate device require onlypolishing.Product performs withinrequirements.

Table 5.1 Substantial equivalence to the primary predicate device (GRADIA)

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	Table 5.2 Substantial equivalence to the reference predicate device (GRADIA GUM)

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	Applicant device	Reference devices		DifferenceY/N	Impact on Effectiveness andrationale
Trade name	GRADIA PLUS	G-aenial Sculpt (MFP-051)	OPTIGLAZE color (Nanocoat color)
Productcategory	Light-cured composite forcrown and bridge	Light-cured compositerestorative	Light-curedcharacterization material
Manufacturer	GC Corporation	GC Corporation	GC Corporation
510(K) No.	K153325	K123631	K133836
Number ofShades	73	17	17	Y	Shade number does notimpact on safety or efficacy.
Indicationsfor use	1. Crown and Bridgework(with metal backing)2. Metal free restorations:Jacket Crowns, Inlays, Onlaysand Laminated Veneers3. Implant superstructures4. Reproduction of gum tissuefor crown restorations	1. Direct restorative for class I,II, III, IV, V cavities.2. Direct restorative for wedge-shaped defects and rootsurface cavities.3. Direct restorative for veneersand diastema closure.	1. Characterization of direct &indirect composite restorations,acrylic denture base and artificialacrylic teeth.2. For obtaining surfacesmoothness and wear resistanceof restorations made ofcomposite resin, acrylic denturebase and artificial acrylic teeth.	Y	Applicant device includes forreproduction of gum tissue.Comparative devices do notinclude for reproduction ofgum tissue.Product performs withinrequirements.
Productdescription	GRADIA PLUS is a light-cured nano-filled radiopaquecomposite resin filled in asyringe. The device is usedfor crown and bridgeworkwith metal backing, jacketcrowns, inlays, onlays,veneers, implant superstructures and reproductionof gum tissue for crownrestorations.	G-aenial Sculpt (MFP-051) is alight cured nano-filledradiopaque composite resinfilled in a syringe and unitip.The device is used for therestorations of both anteriorand posterior teeth	OPTIGLAZE Color is a light-cured glazing and characterizingmaterial for such restorations asdirect and indirect composites. Itis also used for obtainingsurface smoothness and wearresistance of restorations madeof composite resins and acrylics.The material is available in 17shades.	Y	Applicant device requirescoating or polishing as asurface finish.Product performs withinrequirements.
Instructionsfor Use	1. Preparation2. Treatment3. Build up4. Light curing5. Glazing (Coating andPolishing)	1. Cavity Preparation2. Bonding Treatment3. Placement4. Light Curing5. Finishing and polishing	1. Preparation2. Clean and dry3. Apply4. Light curing (Coating)

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12. Conclusion

Based on formulation, testing and meeting and/or exceeding ISO standards related to performance, we find the applicant device substantial equivalent to the noted predicates.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.