(114 days)
GC RELINE II is a resilient material for making soft relining of dentures.
GC RELINE II is a VPS silicone for relining of dentures. The components consist of the base silicone paste and the catalyst silicone paste that are extruded from a cartridge and are automixed with a mixing tip. GC Reline II is available in the following viscosities: Soft, Extra Soft, and Extra Extra Soft.
The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.
GC Reline Primer for Resin is a resin adhesive that is packaged in a glass bottle.
GC Reline Modifier is available in Liquid A and Liquid B and is similar to the Base and Catalyst of the subject device. Liquid A and Liquid B are dispensed in equal amounts onto the mixing pad and mixed together. It is used to modify (activate) the existing reline surface to accept additional Reline II material.
The provided document describes the FDA 510(k) clearance for the GC Reline II, a denture relining material. This document does not detail a study involving AI or human readers, but rather a non-clinical benchtop study to demonstrate substantial equivalence to a predicate device. Therefore, information regarding human readers, AI assistance, multi-reader multi-case studies, or detailed AI algorithm performance metrics (like sample sizes for training/test sets for AI, data provenance for AI, ground truth for AI, adjudication methods for AI) is not applicable or available in this document.
The acceptance criteria and reported device performance are based on physical properties and biocompatibility in accordance with established ISO standards, comparing the new device (GC Reline II) to a legally marketed predicate device (GC Reline Soft/Extra Soft).
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (via ISO 10139-2:2009) | Reported Device Performance (GC Reline II) |
|---|---|---|
| Physical Properties | ||
| Shore A hardness, 24h | Meets specifications in ISO 10139-2 | Meets specifications in ISO 10139-2 |
| Shore A hardness, 28d | Meets specifications in ISO 10139-2 | Meets specifications in ISO 10139-2 |
| Bond strength (MPa) | Meets specifications in ISO 10139-2 | Meets specifications in ISO 10139-2 |
| Sorption (µg/mm³) | Meets specifications in ISO 10139-2 | Meets specifications in ISO 10139-2 |
| Solubility (µg/mm³) | Meets specifications in ISO 10139-2 | Meets specifications in ISO 10139-2 |
| Biocompatibility | ||
| Cytotoxicity Test (ISO 10993-1, 10993-5) | Meets test requirements | Pass |
| Irritation and Sensitization (ISO 10993-10) | Meets test requirements | Pass |
Note: The document explicitly states: "Bench top testing indicates that even with different formula, applicant device and predicate devices, meet specifications listed in ISO 10139-2. Therefore, the applicant and predicate device are substantially equivalent. There are no statistically significant differences between GC RELINE II and GC RELINE when comparing performance data."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the benchtop tests (e.g., number of denture material samples tested for hardness, bond strength, etc.). It refers to testing being done "in accordance with ISO 10139-2," which implies that the material property tests were conducted on batches or samples as prescribed by the standard.
- Data Provenance: The data is from non-clinical benchtop testing. No information is provided regarding the country of origin, but the testing was conducted by GC America, Inc. or contractors on their behalf. The data is prospective in the sense that it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This was a non-clinical benchtop study evaluating material properties and biocompatibility against ISO standards, not a study involving medical image interpretation or diagnosis requiring human expert consensus. The "ground truth" for material properties is determined by the physical and chemical measurements themselves, compared against the predefined thresholds in the ISO standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this was a non-clinical benchtop study, there was no need for adjudication involving human readers or experts to determine a "ground truth" based on consensus. The results are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not done. This submission is for a medical device (denture relining material), not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This document pertains to a physical dental material, not an algorithm or AI system.
7. Type of Ground Truth Used
- The ground truth used was objective measurements of physical properties and biological responses (biocompatibility) compared against established International Organization for Standardization (ISO) standards:
- ISO 10139-2:2009 (Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use) for physical properties.
- ISO 10993 series (Biological evaluation of medical devices) for biocompatibility.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device and study, as it is not an AI/machine learning device. The device's formula and manufacturing processes are developed and optimized by the manufacturer, but this doesn't constitute a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI training set, this question is not relevant to this submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2016
GC America, Inc. Mr. Mark Heiss Director, Regulatory & Academic Affairs 3737 W. 127th St. Alsip. Illinois 60803
Re: K153253
Trade/Device Name: GC Reline II Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: February 1, 2016 Received: February 3, 2016
Dear Mr. 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 - Mr. Mark Heiss
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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
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, 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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Indications for Use
510(k) Number (if known) K153253
Device Name
GC Reline II
Indications for Use (Describe)
GC RELINE II is a resilient material for making soft relining of dentures.
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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Image /page/3/Picture/0 description: The image shows the letters 'GC' in a stylized, teal-colored font. The letters are slightly italicized and have a bold appearance. There are quotation marks before and after the letters.
GC AMERICA INC.
3737 W 127 STREET
ALSIP, ILLINOIS 60803
TEL (708) 597-0900
FAX (708) 926-9100
www.gcamerica.com
K153253 510(k) Summary
February 29, 2016 Date Prepared:
- Submitter Information: 1.
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) 926-9100 |
-
- Device Name: Proprietary Name: Classification Name: CFR Regulation: Device Classification: Product Code:
GC RELINE II Denture relining, repairing or rebasing resin 21CFR 872.3760 Class II EBI
- Device Name: Proprietary Name: Classification Name: CFR Regulation: Device Classification: Product Code:
-
- Predicate Device:
| Company | Device | 510(k) | Date Cleared |
|---|---|---|---|
| GC America, Inc. | GC Reline Soft/Extra Soft | K990376 | March 5, 1999 |
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-
- Description of Device:
GC RELINE II is a VPS silicone for relining of dentures. The components consist of the base silicone paste and the catalyst silicone paste that are extruded from a cartridge and are automixed with a mixing tip. GC Reline II is available in the following viscosities: Soft, Extra Soft, and Extra Extra Soft.
- Description of Device:
The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.
GC Reline Primer for Resin is a resin adhesive that is packaged in a glass bottle.
GC Reline Modifier is available in Liquid A and Liquid B and is similar to the Base and Catalyst of the subject device. Liquid A and Liquid B are dispensed in equal amounts onto the mixing pad and mixed together. It is used to modify (activate) the existing reline surface to accept additional Reline II material.
న. Indications for Use: GC RELINE II is a resilient material for making soft relining of dentures.
-
- Technological characteristics:
The components of GC RELINE II and the predicate device are similar. The subject device GC Reline II contains a new ingredient, Polydimethylsiloxane, which is used in each of the three viscosities. Bench testing demonstrates that the addition of the new ingredient does not impact technological characteristics when compared to the predicate K990376. The curing mechanism of the applicant and predicate devices is by polymerization of uncured vinyl polysiloxane. This reaction is caused by chemical polymerization initiator systems. Bench top testing indicates that even with different formula, applicant device and predicate devices, meet specifications listed in ISO 10139-2.
- Technological characteristics:
Therefore, the applicant and predicate device are substantially equivalent. There are no statistically significant differences between GC RELINE II and GC RELINE when comparing performance data.
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| Applicant device | Primary Predicate | |
|---|---|---|
| Product category | CHAIRSIDEVINYLPOLYSILOXANERESILIENT DENTURE LINER | CHAIRSIDEVINYLPOLYSILOXANERESILIENT DENTURE LINER |
| Trade name | GC RELINE II | GC RELINE (Soft/ Extra Soft) |
| 510(k) Number | K153253 | K990736 |
| Indications forUse | GC RELINE II is a resilient material formaking soft relining of dentures. | GC RELINE Soft Extra Soft is a resilientmaterial for making soft relining of dentures. |
| Device Description | GC RELINE II is a VPS silicone for reliningof dentures. The device consists of the basepaste and the catalyst paste Including VPS.The material sets by mixing the catalyst pastewith the base paste. | GC RELINE is a VPS silicone for relining ofdentures. The device consists of the base pasteand the catalyst paste Including VPS. The materialsets by mixing the catalyst paste with the basepaste. |
| DeviceComponents | Base:Silicon dioxideVinyldimethylpolysiloxaneMethylhydrogen dimethylpolysiloxanePolydimethylsiloxane*ColorantCatalyst: Silicon dioxideVinyldimethylpolysiloxanePolydimethylsiloxane*Platinum Catalyst | Base:Silicon dioxideVinyldimethylpolysiloxaneMethylhydrogen dimethylpolysiloxaneMethylphenylpolysiloxaneColorantCatalyst: Silicon dioxideVinyldimethylpolysiloxanePlatinum Catalyst |
| Similar PhysicalProperties(tested inaccordance withISO 10139-2) | Shore A hardness, 24hShore A hardness, 28dBond strength (MPa)Sorption( $[\mu$ /mm3)Solubility ( $[\mu$ /mm3) | Shore A hardness, 24hShore A hardness, 28dBond strength (MPa)Sorption( $[\mu$ /mm3)Solubility ( $[\mu$ /mm3) |
| Composition ofMaterials | Cartridge - high density polyethyleneCap - polypropyleneMixing tip - polypropylene.GC Reline II Primer for Resin-8g glass bottle.GC Reline II Modifier-polypropylene bottle.GC Reline II Remover-high densitypolyethylene. | Cartridge - high density polyethyleneCap-polypropyleneMixing tip - polypropylene.GC Reline II Primer for Resin - 8 g glass bottle.GC Reline II Modifier-polypropylene bottle. |
| Standards ofConformity | ISO 10139:2009, Sections 5.1, 5.2, 5.3ISO10993-1:2009, Sections 6.2.2.2, 6.2.2.3,6.2.2.4ISO 10993-2:2006ISO 10993-5:2009 Sections 8.5ISO 10993-10:2010, Sections 6, 7 | Not available |
| Biocompatibility | 10993-5 Cytotoxicity - pass10993-10 irritation - pass10993-10 sensitization - pass | Not available |
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Biocompatibility Testing
| Test | Test Standard | Test Results(pass or fail) |
|---|---|---|
| Cytotoxicity Test | Under the conditions of ISO 10993-1:2009, Biological evaluation of medicaldevices, sections 6.2.2.2, 6.2.2.3, 6.2.2.4, the test articles should meet the testrequirements | Pass |
| Cytotoxicity TestIn Vitro | Under the conditions of ISO 10993-5:2009, Biological evaluation of medicaldevices, section 8.5 Determination of cytotoxicity, the test articles should meetthe test requirements | Pass |
| Irritation andSensitization | Under the conditions of ISO 10993-10:2010, biological evaluation of medicaldevices, Sections 6, 7, the test articles should meet thetest requirements | Pass |
7. Nonclinical Testing:
Benchtop testing demonstrates that the subject device GC Reline II, like its predicate device GC Reline Soft/Extra Soft, is in compliance with ISO 10139-2:2009 Dentistry-Soft lining materials for removable dentures-Part 2: Materials for long-term use, and as such, the subject device meets specific requirements for softness, adhesion, water sorption and water solubility as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. The subject device GC Reline II was also tested and met the requirement for cytotoxicity, irritation and sensitivity as shown in the biocompatibility table above.
8. Substantial equivalence:
The subject device GC RELINE II and its predicate device GC RELINE (Soft/ Extra Soft) share the same function and intended use. The curing mechanism of the new and predicate device is equivalent. Bench testing demonstrates that the addition of a new ingredient in the subject device does not impact technological characteristics when compared to the predicate K990376.
The subject device and predicate devices encompass the same range of physical dimensions, including hardness, bond strength, sorption, solubility, and also share equivalent biocompatibility. Both the subject and predicate devices are provided nonsterile and have a shelf life of 2 years. Any differences in the technological characteristics do not raise new questions.
GC AMERICA INC. has demonstrated that, for the purposes of FDA's regulation of medical devices, the subject device GC Reline II is substantially equivalent to the predicate device in intended use, material composition, fundamental scientific technology, principals of operation, and basic design.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.