GingiDent Gingival Retraction Paste

K162662 · Pac-Dent International, Inc. · MVL · Oct 20, 2017 · DE

Device Facts

• Record ID: K162662
• Device Name: GingiDent Gingival Retraction Paste
• Applicant: Pac-Dent International, Inc.
• Product Code: MVL · DE
• Decision Date: Oct 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

GingiDent is an astringent paste containing Aluminum Chloride Hexahydrate in a water-based kaolin carrier; used by dental professionals in clinical settings. Paste is applied to gingival margin to provide mechanical retraction and chemical hemostasis; facilitates procedures like impressions, cementation, and cavity preparation. Device acts via physical displacement by kaolin and astringent action of Aluminum Chloride. Clinician applies paste to gingival sulcus; output is a retracted, dry gingival margin allowing for accurate dental impressions or restorative work. Benefits include improved visibility and moisture control for the practitioner and reduced tissue trauma compared to traditional retraction cords.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing (pH, viscosity, Aluminum Chloride concentration) and biocompatibility testing (skin sensitivity, oral mucosa irritation in hamsters per ISO 10993). Stability testing performed per ISO 28399-2011.

Technological Characteristics

Astringent paste; composition: Aluminum Chloride Hexahydrate, kaolin, water, propylene glycol, peppermint, and dye. Principle: mechanical retraction via kaolin and chemical hemostasis via Aluminum Chloride. Viscosity: 995,000 cP. Shelf life: 2.8 years. Non-sterile, transient invasive use in oral cavity.

Indications for Use

Indicated for temporary gingival margin retraction and hemostasis during dental procedures including impressions, cementation, and cavity preparation.

Predicate Devices

• Expa-syl (K050180)
• Traxodent (K083695)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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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Image /page/2/Picture/0 description: The image features the logo of Pac-Dent International, Inc. The logo includes the company name in a combination of blue and gray text. To the left of the name is a stylized graphic with an orange swoosh above the word "PacDent" in blue.

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.

K162662

# 510(k) Summary

#### Submitter:

Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821

#### Contact Person:

Jiahe Li Regulatory Affair Associate Tel: [phone] 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 Dental<br>Specialties, Inc. | Premier Dental<br>Products |
|----------------------------------|-----------|------------------------------------|----------------------------|
| Product | GingiDent | Expa-syl | Traxodent |
| Aluminum Chloride<br>Hexahydrate | 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.

| Descriptive<br>Information | Subject<br>Device<br>GingiDent<br>Gingival<br>Retraction<br>Paste | Primary<br>Predicate<br>Device<br>Expa-syl<br>(K050180) | Reference Device<br>Traxodent (K083695) | Substantial<br>Equivalence |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------|----------------------------|
| Indications for<br>Use | GingiDent Gingival Retraction Paste: For the<br>temporary retraction and hemostasis of the gingival<br>margin during dental procedures such as, but not<br>limited to taking an impression, cementation, cavity<br>preparation.<br><br>K050180: Expa-syl is a paste containing aluminum<br>chloride which is intended to be used for the temporary<br>retraction and hemostasis of the gingival margin during<br>dental procedures such as, but not limited to, dental<br>impressions, seating of temporary and permanent<br>restorations, 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 formulated<br>to provide gingival retraction and hemostasis. It is<br>intended for use prior to taking an impression, for cavity<br>preparation or wherever hemostasis and retraction is<br>required.<br><br>Comments: All three devices are used for gingival<br>retraction and hemostasis as required during dental<br>procedures. The key words are the same. The small<br>differences in the language used do not impact the<br>substantial equivalence of the subject device to the<br>predicate device in terms of Indications for Use. | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Composition of<br>Materials | Same:<br>Aluminum Chloride Hexahydrate in a water-based<br>kaolin paste.<br><br>Difference:<br>Dye<br>(blue-green)<br>Propylene<br>Glycol,<br>Peppermint | Yes |
| | Difference:<br>Dye<br>(grey-green) | |
| | Difference:<br>Dye (yellow) | |
| | Comments: The subject device and predicate devices<br>comprise of the same main ingredients: aluminum<br>chloride hexahydrate, kaolin and water. The<br>percentage of kaolin used in the subject device and<br>main predicate device is comparable. The Propylene<br>Glycol is an inactive ingredient used in subject device<br>as a solvent. Peppermint is an inactive ingredient used<br>in subject device as a flavor. The dye used in subject<br>device is different but doesn't impact the effectiveness<br>and safety of the subject device. | |
| Principles of<br>Operation | Same:<br>In the retraction process, light kaolin ensures the<br>consistence of paste and its mechanical action while | Yes |
| | | |
| | and aluminum chloride enhances the hemostatic | |
| | action.¹<br>DI water is used to dissolve the astringent agent and<br>give a paste of the desired viscosity, texture and<br>appearance.<br>Difference: None.<br>Comment: The principles of operation of the subject<br>device are the same as the predicate devices. | |
| Physical<br>Property | See previous section <i>Bench Tests Result Summary</i> for<br>details.<br>Comment: While the two predicate devices show big<br>differences in their viscosity measurements<br>comparatively, the difference in viscosity does not<br>affect the effectiveness (the active ingredient is<br>Aluminum Chloride Hexahydrate). It is up to the<br>manufacturer to decide the best viscosity for its<br>formulation in consideration of stability, handling and<br>customer feedback. Therefore, there is sufficient<br>evidence to conclude that the difference in viscosity<br>does not affect the effectiveness of the subject device<br>for its intended use, which has a viscosity level that falls<br>between that of the two predicate devices. | Yes |
| Device<br>Classification &<br>Product Code | Same:<br>Device Classification: Unclassified<br>product 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.