PackFil Resin Modified Glass Ionomer (RMGI) Restorative Cement is used by dental professionals and intended for filling and restoration of teeth. The subject device possesses triple curing mechanisms of conventional acid-base glass ionomer reaction. methacrylate resin chemical curing and light curable on demand. It is a tooth colored, radiopaque (equivalent of 2.5 mm of aluminum), two-part paste/paste resin modified glass ionomer restorative cement material, with each part is packaged separately when not in use. PackFil RMGI provides the common benefits typical of conventional glass ionomer materials, with the feature of being packable after the two parts mixed together. The filler content of this system is primarily a combination of traditional silane treated barium-boro-silicate glass filler and radiopaque acid reactive fluoroaluminosilicate glass filler having a hybrid particle size range from about 0.01 up to about 5 micrometers while the resin system has a combination of aqueous polyacrylic acid copolymer, phosphate and other polymerizable methacrylate resins.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental product, "PackFil™ Resin Modified Glass Ionomer Restorative Cement." This document focuses on demonstrating the substantial equivalence of the new device to existing legally marketed predicate devices, rather than an AI-based device's performance against clinical acceptance criteria in the way a diagnostic AI would be evaluated.

Therefore, many of the requested categories for AI device evaluation (such as sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) are not applicable to this document as it pertains to a dental restorative cement, not an AI diagnostic tool.

However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its performance against industry standards, which serves as its "acceptance criteria" in this context.

Here's an interpretation based on the given document:

1. A table of acceptance criteria and the reported device performance

For a dental material, the "acceptance criteria" are typically defined by recognized international standards (like ISO) and comparative performance to predicate devices. The document explicitly states that the performance data satisfies ISO 9917-2.

Performance Metric	Acceptance Criteria (Satisfies ISO 9917-2)	Reported Device Performance (PackFil RMGI)
Bonding Strength to Resin composite	Defined by ISO 9917-2 (not explicitly stated here)	18 MPa (Self-cured), 22 MPa (Light cured)
Flexural Strength	Defined by ISO 9917-2 (not explicitly stated here)	41 MPa (Self-cured), 36 MPa (Light cured)
Compressive Strength	Defined by ISO 9917-2 (not explicitly stated here)	245 MPa (Self-cured), 230 MPa (Light cured)
Radiopacity	Defined by ISO 9917-2 (not explicitly stated here)	2.5 mm aluminum equivalent
Self-cure working time	Defined by ISO 9917-2 (not explicitly stated here)	3 minutes
Self-cure setting time (from start)	Defined by ISO 9917-2 (not explicitly stated here)	6 minutes
Depth of cure (VLC for 20'')	Defined by ISO 9917-2 (not explicitly stated here)	3 mm
Sensitivity to Ambient Light	Defined by ISO 9917-2 (not explicitly stated here)	>60 seconds

Biocompatibility Acceptance Criteria and Results:

The biocompatibility studies were selected according to ISO 10993-1:2009.

ISO Test Method	Test Description	Acceptance Criteria (Implicit for safety)	Result Summary
10993-5:2009	Cytotoxicity - L929MEM Elution	No cytotoxic effect	No cytotoxic effect
10993-10:2010, 3ed	Irritation - Intracutaneous Injection	Not more than control article	Not more than the control article
10993-3:2003, 2ed	Genotoxicity - Mutation Study	Non-mutagenic	Non-mutagenic
10993-10:2010, 3ed	Sensitization Maximization	No sensitization	No sensitization
10993-6:2007	Implantation - four weeks	Same as negative control	Same as the negative control

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document presents summary bench testing results and biocompatibility study results, but does not detail the sample sizes for these tests or the specific provenance of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes a material for dental restoration, not an AI diagnostic device where 'ground truth' is established by human experts on clinical data. The performance metrics are measured through laboratory bench tests and standard biological assays.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reasons as #3.

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 is not applicable as the document describes a dental material, not an AI diagnostic device.

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

This is not applicable as the document describes a dental material, not an AI algorithm. The performance presented ("reported device performance") is the standalone performance of the material itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance metrics, the "ground truth" (or reference standard) is established by objective measurements under controlled laboratory conditions following international standards (ISO 9917-2) for material properties and standard biological assays following ISO 10993-1:2009 for biocompatibility. There is no human interpretative "ground truth" in the clinical sense for this type of device.

8. The sample size for the training set

This is not applicable as the document describes a manufactured dental material, not a machine learning model that undergoes a "training set" phase.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as #8.

Summary

{0}------------------------------------------------

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 the perimeter. In the center is a stylized representation of a human figure, with three profiles overlapping to symbolize health and human services. The seal is black and white.

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

April 5, 2016

Gaia Dental Products, Inc. Weitao Jia President 290 Pratt Street, Unit 2314 Meriden, Connecticut 06450

Re: K152652

Trade/Device Name: PackFil™ Resin Modified Glass Ionomer Restorative Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA, EBF Dated: February 18, 2016 Received: February 24, 2016

Dear Weitao Jia:

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.

{1}------------------------------------------------

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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education 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,

Image /page/1/Picture/8 description: The image shows a signature of Tina Kiang -S. The signature is written in black ink on a white background. The signature is illegible, but it appears to be written in cursive. The signature is followed by the letters "-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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K152652

Device Name

PackFil Resin Modified Glass Ionomer Restorative Cement

Indications for Use (Describe)

PackFil RMGI Restorative Cement is indicated for filling and restoration of tooth of following typical applications:

· Primary teeth restorations;
· Class I restorations:
· Class III and V restorations:
· Transitional restorations;
· Base liners or laminated/sandwich restorations;
· Selective core build-ups (>50% coronal tooth intact);

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

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 pata needed announg the and review the collection of information. Send comments regarding this burden estimate or any other spect 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."

{3}------------------------------------------------

510(k) Summary

K152652

Submitter:

Gaia Dental Products, Inc. 290 Pratt Street, Unit 2314 Meriden, CT 06450 (203) 238-1181- Phone (203) 294-0461 - Facsimile Weitao Jia -Contact Person

Date Summary Prepared/modified: April 4, 2016

Device Name:

Trade Name – PackFil™ Resin Modified Glass Ionomer Restorative Cement
Common Name – Resin Modified Glass Ionomer Dental Cement
Classification Name EMA, Dental Cement, per 21 CFR § 872.3275 ●
Additional Product Code - EBF, Tooth Shade Resin Material

Devices for Which Substantial Equivalence is Claimed:

Primary Predicate: GC, Fuji Filling LC; K051427

Reference Predicate: 3M ESPE, Ketac Nano Glass Ionomer Restorative; K 052235

Device Description:

{4}------------------------------------------------

PackFil RMGI Restorative Cement is packaged in a dual barrel cartridge system such as the dental MixPac®* 4 ml dual-barrel syringe or their equivalents. The picture below illustrates the mode of operation by using a matching auto-mixing tip attached to the syringe orifice and dispensed with help of using the MixPac® dispensing gun, or simply by hand; or the cement material can be pushed out with hand from the syringe on a mixing pad and subsequently mixed using a dental spatula and deliver, if desirable.

Image /page/4/Picture/1 description: The image shows a MixPac 5 ml double barrel cartridge gun with auto-mixing tips. The gun has a hand-operated cartridge plunger. There are also tubes of PackFil cement dispensing on a pad, mixing with a dental spatula.

*MixPac® dual cartridge systems and dispensing accessories for dental use are products of Sulzer MIXPAC USA, Inc.

The PackFil Resin Modified Glass Ionomer Restorative Cement product is sold to clinicians in kits or refills. A Kit is essentially a set of the various shaded material bundled together. The clinician receives the devices packaged clean, but non-sterile, in appropriate, labeled containers with instructions for use enclosed.

Summary of Kev Performance Testing Results – bench

	Self-cured	Light cured
Bonding Strength toResin composite	18 MPa	22 MPa
Flexural Strength ( MPa)	41 MPa	36 MPa
Compressive Strength (MPa) 245 MPa		230 MPa
Radiopacity		2.5 mm aluminum equivalent
Self-cure working time	3 minutes	N/A

{5}------------------------------------------------

Self-cure setting time(From start of mixing)	6 minutes	N/A
Depth of cure (VLC for 20'')	N/A	3 mm
Sensitivity to Ambient Light	N/A	>60 seconds

The performance data above satisfies the specification of ISO 9917-2: Dentistry – Water Based Cements - Part 2: Resin Modified Cements, where applicable.

Indications for Use:

PackFil RMGI Restorative Cement is indicated for filling and restoration of tooth of following typical applications:

Primary teeth restorations;
. Class I restorations;
. Class III and V restorations;
Transitional restorations;
. Base liners or laminated/sandwich restorations;
Selective core build-ups (>50% coronal tooth intact);

Substantial Equivalence:

PackFil RMGI Restorative Cement is substantially equivalent to two other legally marketed devices in the United States. PackFil RMGI functions in a manner similar to and is intended for the same use as the Fuji Filling LC, marketed by GC America , and Ketac Nano Glass lonomer Restorative, marketed by 3M ESPE. Every component used in the PackFil RMGI is commonly used in a variety of dental resin modified glass ionomers, resin composites, dental cements and dental bonding system products.

Similar to the predicate devices, PackFil RMGI is a catalyst/base paste formulation, which combines a conventional acid-base glass ionomer cement reaction with modification of methacrylate resin chemistry which allows for self-cure and/or light cure. The application procedures and indications have not deviated from the prior generations of conventional restorative glass ionomer cements as well as the substantial equivalent predicate devices.

{6}------------------------------------------------

Product	Description	Intended Use	Indications for Use	General Composition
PackFilResinModifiedGlassIonomerRestorativeCement	A paste-paste formresinmodifiedglassionomercement	Dentalrestorativeas a fillingand/or baseliner	• Primary teethrestorations;• Class I restorations;• Class III and Vrestorations;• Transitionalrestorations;• Base liners orlaminated/sandwichrestorations;• Selective core build-ups (>50% coronal toothintact);	Part A: A blend ofaqueous polyacrylicacid, methacrylate andphosphatemethacrylate resins,silane treated glass,silica, andpolymerizationcomponent;Part B: A blend ofmethacrylate resins,ionomer glass, zincoxide, calciumphosphate, silica,polymerizationcomponents andpigments
3M ESPEKetacNanoGlassIonomerRestorativeK052235	A paste-paste formresinmodifiedglassionomercement	Dentalrestorativeas a fillingand/or baseliner	• Primary teeth restorations• Small Class I restorations• Class III and V restorations• Transitional restorations• Filling defects and undercuts• Laminate/Sandwich technique• Small core build-ups where atleast 50% of coronal toothstructure is remainingfor support	Part A: Silane-treatedglass, zirconia andsilica; ionomer glass;methacrylate resins.Photo- polymerizationinitiators.Part B: Silane-treatedceramic;methacrylate-modifiedco-polymer of acrylicand itaconic acids;methacrylate; water,
GC FujiFilling LCK051427	A paste-paste formresinmodifiedglass	Dentalrestorativeas a fillingand/or baseliner	• Class V Restorations• Under posteriorcomposites• Class III Restorations• Class I PediatricRestorations and Core	Part A:Aluminoflurosilicateionomer glass;methacrylate resins.Photo-initiator.

Table below listed in chart form, the similarities between the submitted device, PackFil Resin Modified Glass Ionomer Restorative Cement and the two predicate devices

510(K) Submission for PackFil Resin Modified Glass Ionomer Cement

{7}------------------------------------------------

ionomer		Build-Ups	Part B: Polyacrylic acid; water; methacrylate and filler.
cement

Biocompatibility studies of PackFil RMGI Restorative Cement have been selected according to ISO 10993-1:2009. The following studies were performed with the results summarized below:

Test No.	ISO Test Method	Test Description	Result Summary
1	10993-5:2009	Cytotoxicity-L929MEM Elution	No cytotoxic effect
2	10993-10:2010, 3ed	Irritation -Intracutaneous Injection	Not more than thecontrol article
3	10993-3:2003, 2ed	Genotoxicity -Mutation Study	Non-mutagenic
4	10993-10:2010, 3ed	SensitizationMaximization	No sensitization
5	10993-6:2007	Implantation - fourweeks	Same as the negativecontrol

Conclusion

Based upon the descriptive and comparative data provided within this submission, we have demonstrated substantial equivalency of PackFil Resin Modified Glass ionomer Restorative Cement material in design/composition, intended use, indications of use and performances including biocompatibility to its predicate devices. Therefore, this PackFil Resin Modified Glass Ionomer Restorative Cement is substantially equivalent to the declared predicate devices.

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.