(389 days)
For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation and cavity preparation.
GingiDent gingival retraction paste is an astringent formulated to provide gingival retraction and hemostasis. GingiDent gingival retraction paste contains Aluminum Chloride and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. This product is a blue-green paste developed exclusively for transient surgically invasive use in the oral cavity. The paste contains Aluminum Chloride in a water-based clay inert carrier.
This document describes the premarket notification (510(k)) for the GingiDent Gingival Retraction Paste. The submission primarily relies on non-clinical bench testing and comparison to predicate devices, rather than a clinical study involving human subjects. Therefore, many of the requested categories related to clinical study design and outcomes (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (Bench Test Results) and Reported Device Performance:
| Test | Acceptance Criteria (Implied by Predicate Range) | GingiDent (Subject Device) Performance | Predicate Device 1 (Expa-syl) Performance | Predicate Device 2 (Traxodent) Performance |
|---|---|---|---|---|
| Aluminum Chloride Hexahydrate | Within range of predicates (15.80% - 21.76%) | 16.42% | 15.80% | 21.76% |
| pH | Within range of predicates (2.99 - 3.47) | 3.22 | 3.47 | 2.99 |
| Viscosity (cP) | Not explicitly defined, but between predicates | 995,000 | >1 million | 763,000 |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The testing described is bench testing of the product itself, not a clinical test set with human subjects.
- Data Provenance: Not applicable for a clinical test set. The data originates from laboratory bench testing conducted by the manufacturer, Pac-dent International, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was bench testing, not a clinical study requiring expert ground truth for patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was bench testing.
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:
- No. This device is a gingival retraction paste, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical dental paste, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable to a clinical test set. For the bench tests, the "ground truth" was established by standard laboratory measurement techniques for pH, viscosity, and chemical concentration.
8. The sample size for the training set:
- Not applicable. This is not a machine learning device; therefore, there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable.
Additional Information from the Document:
- Biocompatibility Tests: Performed in accordance with ISO 10993, including skin sensitivity and oral mucosa irritation tests in hamsters. Results showed no evidence of causing skin sensitization or oral mucosa irritation.
- Stability Tests: Accelerated stability testing was conducted at 50 °C and 60 °C, evaluating AlCl3-6H2O concentration, pH value, extrusion force, and weight loss. Estimated shelf life for room temperature storage is 2.8 years.
- Clinical Performance Test: "No clinical testing was provided." The submission relies solely on non-clinical (bench) testing and comparison to legally marketed predicate devices to establish substantial equivalence.
- Conclusion: The manufacturer concluded that GingiDent Gingival Retraction Paste is substantially equivalent to the identified predicate devices based on non-clinical performance testing. The FDA concurred with this determination for the purpose of market authorization.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2017
Pac-dent International, Inc Jack Li Regulatory Affair Associate 670 Endeavor Circle Brea, California 92821
Re: K162662
Trade/Device Name: GingiDent Gingival Retraction Paste Regulation Number: 21 CFR Regulation Name: (Not A Regulation) Retraction Cord Regulatory Class: Unclassified Product Code: MVL Dated: September 6, 2017 Received: September 8, 2017
Dear Jack Li:
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.
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 (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.
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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,
Mary S. Runner -S
for Tina Kiang, Ph.D. Acting 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 III
Indications for Use Statement
510(k) Number (if known): K162662
Device Name: __ GingiDent Gingival Retraction Paste
Indications for Use:
For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation and cavity preparation.
OR
Prescription Use
C
Over-The-Counter Use
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ac-Dent International, Inc.
510(k) Summary
Submitter:
Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821
Contact Person:
Jiahe Li Regulatory Affair Associate Tel: 909-839-0888 ext.109
Date Summary Prepared:
October 16th, 2017
DEVICE NAME
TRADE NAME: GingiDent Gingival Retraction Paste
COMMON NAME: Retraction Cord
DEVICE CLASSIFICATION: Unclassified
CLASSIFICATION PRODUCT CODE: MVL
PREDICATE DEVICE
Primary predicate device: Expa-syl - Sybron Dental Specialties, Inc. - K050180 Reference predicate device: Traxodent - Premier Dental Products Co - K083695
DESCRIPTION OF DEVICE
GingiDent gingival retraction paste is an astringent formulated to provide gingival retraction and
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Image /page/4/Picture/0 description: The image shows the logo for Pac-Dent International, Inc. The logo features the company name in a stylized font, with the "PacDent" portion in blue and the "Pac-Dent International, Inc." portion in gray. There is an orange graphic to the left of the company name.
hemostasis. GingiDent gingival retraction paste contains Aluminum Chloride and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. This product is a blue-green paste developed exclusively for transient surgically invasive use in the oral cavity. The paste contains Aluminum Chloride in a water-based clay inert carrier.
INDICATIONS FOR USE
For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation and cavity preparation.
Non-Clinical Tests
This 510(k) submission includes data from bench testing to evaluate the performance of the subject device compared to predicate devices. Tests performed include measurement of pH value, viscosity and Aluminum Chloride Hexahydrate concentration.
| Manufacturer | Pac-Dent | Sybron DentalSpecialties, Inc. | Premier DentalProducts |
|---|---|---|---|
| Product | GingiDent | Expa-syl | Traxodent |
| Aluminum ChlorideHexahydrate | 16.42% | 15.80% | 21.76% |
| pH | 3.22 | 3.47 | 2.99 |
| Viscosity (cP) | 995,000 | >1 million | 763,000 |
Bench Tests Result Summary
Conclusion of Bench Tests
GingiDent Gingival Retraction Paste is substantially equivalent to the predicate devices Expa-syl and Traxodent in terms of active ingredients and pH value. While the two predicate devices show big differences in their viscosity measurements comparatively, the difference in viscosity does not affect the effectiveness (the active ingredient is Aluminum Chloride Hexahydrate). It is up to the manufacturer to decide the best viscosity for its formulation in consideration of stability, handling and customer feedback. Therefore, there is sufficient evidence to conclude that the difference in viscosity does not affect the effectiveness of the subject device for its intended use, which has a viscosity level that falls between that of the two predicate devices.
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Image /page/5/Picture/0 description: The image contains the logo for Pac-Dent International, Inc. The logo features the company name in two different fonts and colors. The words "PacDent" are in a bold, blue font, while the words "Pac-Dent International, Inc." are in a lighter, gray font.
Summary of Biocompatibility Tests
Biocompatibility tests in accordance with ISO10993 have been performed, including skin sensitivity test and oral mucosa irritation tests in hamster. The results of the tests show no evidence of causing skin sensitization and oral mucosa irritation.
Summary of Stability Tests
In accordance with the requirements of ISO 28399-2011, the accelerated stability of retraction paste with high viscosity was investigated over the time of incubation in an oven at 50 °C and 60 °C. At a predetermined time point, the retraction paste was evaluated in terms of AICI3-6H2O concentration, pH value, extrusion force, weight loss, and etc. Based on the results obtained, the shelf life of the retraction paste for room temperature storage was estimated to be 2.8 years, which is substantially equivalent to the predicate devices.
Clinical Performance Test
No clinical testing was provided.
| DescriptiveInformation | SubjectDeviceGingiDentGingivalRetractionPaste | PrimaryPredicateDeviceExpa-syl(K050180) | Reference DeviceTraxodent (K083695) | SubstantialEquivalence |
|---|---|---|---|---|
| Indications forUse | GingiDent Gingival Retraction Paste: For thetemporary retraction and hemostasis of the gingivalmargin during dental procedures such as, but notlimited to taking an impression, cementation, cavitypreparation.K050180: Expa-syl is a paste containing aluminumchloride which is intended to be used for the temporaryretraction and hemostasis of the gingival margin duringdental procedures such as, but not limited to, dentalimpressions, seating of temporary and permanentrestorations, restorations of cavities and placement of a | Yes |
Comparison of Technological Characteristics
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Image /page/6/Picture/0 description: The image features the logo of Pac-Dent International, Inc. On the left, there is a stylized graphic element in orange, followed by the word "PacDent" in bold, blue font. To the right of "PacDent", the text "Pac-Dent International, Inc." is written in a smaller, gray font.
| K083695: Traxodent has been specifically formulatedto provide gingival retraction and hemostasis. It isintended for use prior to taking an impression, for cavitypreparation or wherever hemostasis and retraction isrequired.Comments: All three devices are used for gingivalretraction and hemostasis as required during dentalprocedures. The key words are the same. The smalldifferences in the language used do not impact thesubstantial equivalence of the subject device to thepredicate device in terms of Indications for Use. | ||
|---|---|---|
| Composition ofMaterials | Same:Aluminum Chloride Hexahydrate in a water-basedkaolin paste.Difference:Dye(blue-green)PropyleneGlycol,Peppermint | Yes |
| Difference:Dye(grey-green) | ||
| Difference:Dye (yellow) | ||
| Comments: The subject device and predicate devicescomprise of the same main ingredients: aluminumchloride hexahydrate, kaolin and water. Thepercentage of kaolin used in the subject device andmain predicate device is comparable. The PropyleneGlycol is an inactive ingredient used in subject deviceas a solvent. Peppermint is an inactive ingredient usedin subject device as a flavor. The dye used in subjectdevice is different but doesn't impact the effectivenessand safety of the subject device. | ||
| Principles ofOperation | Same:In the retraction process, light kaolin ensures theconsistence of paste and its mechanical action while | Yes |
| and aluminum chloride enhances the hemostatic | ||
| action.¹DI water is used to dissolve the astringent agent andgive a paste of the desired viscosity, texture andappearance.Difference: None.Comment: The principles of operation of the subjectdevice are the same as the predicate devices. | ||
| PhysicalProperty | See previous section Bench Tests Result Summary fordetails.Comment: While the two predicate devices show bigdifferences in their viscosity measurementscomparatively, the difference in viscosity does notaffect the effectiveness (the active ingredient isAluminum Chloride Hexahydrate). It is up to themanufacturer to decide the best viscosity for itsformulation in consideration of stability, handling andcustomer feedback. Therefore, there is sufficientevidence to conclude that the difference in viscositydoes not affect the effectiveness of the subject devicefor its intended use, which has a viscosity level that fallsbetween that of the two predicate devices. | Yes |
| DeviceClassification &Product Code | Same:Device Classification: Unclassifiedproduct code: MVL | Yes |
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Image /page/7/Picture/0 description: The image features the logo for Pac-Dent International, Inc. On the left, there is a stylized graphic element in orange, followed by the company name "PacDent" in a bold, blue font. To the right of "PacDent", the text "Pac-Dent International, Inc." is written in a smaller, gray font. The overall design is clean and professional, suggesting a corporate identity.
Conclusion
In summary, non-clinical performance testing demonstrates that Gingival retraction paste is substantially equivalent to the identified products for its intended use.
1 Dr. Ara Nazarian. (2007, September). Tissue Management with Expasyl; A Key to Restorative Success. Dentaltown, 52.
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