K Number
K152652
Device Name
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
Date Cleared
2016-04-05

(202 days)

Product Code
Regulation Number
872.3275
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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);
Device Description
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.
More Information

Not Found

No
The device description and performance studies focus on the material properties and curing mechanisms of a dental cement, with no mention of AI or ML.

No.
The device is described as a restorative cement for filling and restoration of teeth, which is a dental material, not a therapeutic device. It does not actively treat or cure a disease beyond filling a cavity.

No

This device is a restorative cement used for filling and restoration of teeth, which is a treatment rather than a diagnostic function.

No

The device description clearly states it is a "two-part paste/paste resin modified glass ionomer restorative cement material" and describes its physical properties and chemical composition, indicating it is a physical material, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this product is a restorative cement used directly on teeth for filling and restoration. It is applied in vivo (within the body), not used to test samples in vitro (outside the body).
  • The description focuses on the material properties and application to teeth. There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on testing bodily fluids or tissues.
  • The performance studies are related to the physical and mechanical properties of the cement and its biocompatibility. These are relevant to a dental restorative material, not an IVD.

Therefore, based on the provided information, PackFil RMGI Restorative Cement is a dental restorative material, not an In Vitro Diagnostic device.

N/A

Intended Use / 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);

Product codes (comma separated list FDA assigned to the subject device)

EMA, EBF

Device Description

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.

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental professionals

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was performed:

Self-curedLight cured
Bonding Strength to Resin composite18 MPa22 MPa
Flexural Strength ( MPa)41 MPa36 MPa
Compressive Strength (MPa)245 MPa230 MPa
Radiopacity2.5 mm aluminum equivalent
Self-cure working time3 minutesN/A
Self-cure setting time (From start of mixing)6 minutesN/A
Depth of cure (VLC for 20'')N/A3 mm
Sensitivity to Ambient LightN/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.

Biocompatibility studies selected according to ISO 10993-1:2009 were performed:

Test No.ISO Test MethodTest DescriptionResult Summary
110993-5:2009Cytotoxicity-L929MEM ElutionNo cytotoxic effect
210993-10:2010, 3edIrritation - Intracutaneous InjectionNot more than the control article
310993-3:2003, 2edGenotoxicity - Mutation StudyNon-mutagenic
410993-10:2010, 3edSensitization MaximizationNo sensitization
510993-6:2007Implantation - four weeksSame as the negative control

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K051427, K052235

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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,

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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)

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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:

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.

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-curedLight cured
Bonding Strength to
Resin composite18 MPa22 MPa
Flexural Strength ( MPa)41 MPa36 MPa
Compressive Strength (MPa) 245 MPa230 MPa
Radiopacity2.5 mm aluminum equivalent
Self-cure working time3 minutesN/A

5

| Self-cure setting time

(From start of mixing)6 minutesN/A
Depth of cure (VLC for 20'')N/A3 mm
Sensitivity to Ambient LightN/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

ProductDescriptionIntended UseIndications for UseGeneral Composition
PackFil
Resin
Modified
Glass
Ionomer
Restorative
CementA paste-
paste form
resin
modified
glass
ionomer
cementDental
restorative
as a filling
and/or base
liner• 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);Part A: A blend of
aqueous polyacrylic
acid, methacrylate and
phosphate
methacrylate resins,
silane treated glass,
silica, and
polymerization
component;
Part B: A blend of
methacrylate resins,
ionomer glass, zinc
oxide, calcium
phosphate, silica,
polymerization
components and
pigments
3M ESPE
Ketac
Nano
Glass
Ionomer
Restorative
K052235A paste-
paste form
resin
modified
glass
ionomer
cementDental
restorative
as a filling
and/or base
liner• 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 at
least 50% of coronal tooth
structure is remaining
for supportPart A: Silane-treated
glass, zirconia and
silica; ionomer glass;
methacrylate resins.
Photo- polymerization
initiators.
Part B: Silane-treated
ceramic;
methacrylate-modified
co-polymer of acrylic
and itaconic acids;
methacrylate; water,
GC Fuji
Filling LC
K051427A paste-
paste form
resin
modified
glassDental
restorative
as a filling
and/or base
liner• Class V Restorations
• Under posterior
composites
• Class III Restorations
• Class I Pediatric
Restorations and CorePart A:
Aluminoflurosilicate
ionomer 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

ionomerBuild-UpsPart 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 MethodTest DescriptionResult Summary
110993-5:2009Cytotoxicity-
L929MEM ElutionNo cytotoxic effect
210993-10:2010, 3edIrritation -
Intracutaneous InjectionNot more than the
control article
310993-3:2003, 2edGenotoxicity -
Mutation StudyNon-mutagenic
410993-10:2010, 3edSensitization
MaximizationNo sensitization
510993-6:2007Implantation - four
weeksSame as the negative
control

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.