SULCUS BLUE

K111978 · Produits Dentaires Pierre Rolland · MVL · Oct 13, 2011 · DE

Device Facts

• Record ID: K111978
• Device Name: SULCUS BLUE
• Applicant: Produits Dentaires Pierre Rolland
• Product Code: MVL · DE
• Decision Date: Oct 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

SULCUSBLUE is a paste containing aluminium chloride which is intended to be used, in association with compression caps, for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.

Device Story

SULCUSBLUE is a dental paste containing 15% aluminium chloride; used with compression caps (SULCUSCAP) for temporary gingival retraction and hemostasis. Applied via cannula directly into the gingival sulcus; left in place for 1-2 minutes; removed via air/water spray and aspiration. Used by dental professionals in clinical settings during procedures like dental impressions. Provides a dry, retracted sulcus to facilitate clinical workflows. Benefits include effective bleeding control and gingival margin exposure for accurate impressions.

Clinical Evidence

Bench testing only. Biocompatibility evaluated via tolerance study on scarified hamster cheek pouch mucosa (Study TL 537/05-2908) per NF EN ISO 10993-10. Compared SULCUSBLUE (via HEMOSTASYL proxy) against 0.9% NaCl control. Results showed immediate bleeding cessation, no systemic toxicity, and benign, reversible local irritation within 14 days.

Technological Characteristics

Paste formulation containing 15% aluminium chloride hexahydrate, kaolin, purified water, dye, anhydrous colloidal silica, propylene glycol, and strawberry aroma. Applied via cannula. Used with compression caps. Non-electronic, mechanical/chemical action. Biocompatibility testing performed per NF EN ISO 10993-10.

Indications for Use

Indicated for temporary gingival margin retraction and hemostasis during dental procedures, including dental impressions, in patients requiring such clinical intervention.

Predicate Devices

• HEMOSTASYL (K082116)
• EXPASYL (K050180)
• TRAXODENT (K083695)

Submission Summary (Full Text)

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### 1. Submitter Information:

Produits Dentaires Pierre Rolland ZI du Phare, 17 avenue Gustave Eiffel Mérignac 33700 France Telephone: [phone] Fax: [phone]

Contact person: RICK ROSATI 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: [phone] Fax: [phone]

Date summary prepared: June 30th, 2011

### 2. Device name

SULCUSBLUE Trade Name: Common/Usual Name: Gingival retraction/Hemostatic paste Unclassified Classification Name: MVL Product code:

- 3. Devices for which Substantial Equivalence is claimed:
- HEMOSTASYL (PRODUITS DENTAIRES PIERRE ROLLAND) K082116 dated 12/17/2008 .
- EXPASYL (PRODUITS DENTAIRES PIERRE ROLLAND) K050180 dated 02/11/2005 -
- TRAXODENT (PREMIER DENTAL PRODUCTS CO) K083695 ﺘ

# 4. Device description

SULCUSBLUE is a paste containing aluminium chloride which is used, in association with compression caps (SULCUSCAP), for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.

The paste is applied directly into the sulcus thanks to the a cannula. It is left in place between 1 and 2 minutes depending upon the tonicity of the marginal and removed by an air and water spray with simultaneous aspiration. A dry retracted sulcus is obtained.

Image /page/0/Picture/16 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text is "K111978", with the "K" being a capital letter and the rest being numerical digits. The text is slightly tilted, giving it a dynamic appearance. The handwriting style is simple and clear, making the text easily readable.

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#### Intended use of the Device 5.

SULCUSBLUE is a paste containing aluminium chloride which is intended to be used, in association with compression caps, for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.

### 6. Substantial Equivalence:

SULCUSBLUE is substantially equivalent to other legally marketed devices in the United States: HEMOSTASYL, TRAXODENT and EXPASYL are intended for a similar use (gingival retraction and hemostasis during dental procedures).

### 7 Safety of the Device

Hereafter a comparative table regarding the composition of SULCUSBLUE with the other products: EXPASYL and HEMOSTASYL:

| | SULCUSBLUE | EXPASYL | HEMOSTASYL |
|-----------------------------------|------------|---------|------------|
| Kaolin | X | X | X |
| Aluminium chloride<br>hexahydrate | 15% | 15 % | 15% |
| Purified water | X | X | X |
| Dye | X | X | X |
| Anhydrous colloidal<br>silica | X | - | X |
| Propylene glycol | X | - | X |
| Strawberry Aroma | X | - | X |

Because SULCUSBLUE and HEMOSTASYL have exactly the same composition, we can use for SULCUSBLUE the results of the test performed on HEMOSTASYL:

# · Tolerance study of a dental paste on the injured oral mucosa in the Hamster

- (study TL 537 /05-2908 dated January 13th, 2006)
- Method: according to NF EN ISO 10 993-10 standard February 2003.

Group 1 (control): 0.9% NaCl solution

Group 2 (treated): 0.5ml of HEMSOTASYL (same composition than SULCUSBLUE)-Contact time : 3 minutes* then rinsed with

0.9% NaCl solution

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Results and conclusion: Under the experimental conditions adopted, HEMOSTASYL applied on the scarified mucous membrane of the cheek pouch of the Hamster stopped immediately the bleeding ; it did not induce any systemic toxicity signs. Locally, after 5 days an irritation reaction considered as begnin was noted on the lesion treated with HEMOSTASYL ; it was totally reversible within14 days.

The complete report is presented in Appendix G.

* Under normal conditions of use the contact time of HEMOSTASYL is 2 minutes. The contact time has voluntarily been increased in this test in order to be in the "worse case".

#### CONCLUSION :

Regarding the different results obtained, it appears that SULCUSBLUE stops the bleeding and has a good local and systemic tolerance

According to the results obtained, SULCUSBLUE is substantially equivalent to predicate devices as well as the legally marketed retraction and hemostatic paste.

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Image /page/3/Picture/1 description: The image shows the seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design that resembles an abstract eagle or bird-like figure, composed of three curved lines that converge at the bottom.

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

OCT 1 3 2011

Produits Dentaires Pierre Rolland C/O Mr. Rick Rosati Quality Manager ACTEON. Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054

Re: K111978

Trade/Device Name: SULCUSBLUE Regulation Number: None Regulation Name: Unclassified Regulatory Class: None Product Code: MVL Dated: September 7, 2011 Received: September 8, 2011

Dear Mr. Rosati:

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, I DA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Rosati

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 l'ederal 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 CDRF/'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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

<111.978

510(k) Number (if known):

SULCUSBLUE

Indications For Use:

Device Name:

SULCUSBLUE is a paste containing aluminium chloride which is intended to be used, in association with compression caps, for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.

Please refer to the attached file for a complete description.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C. Ree

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K111978

510(k) Pre-market notification for SUL、 NCE راب