SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA

K082470 · Inter-Med, Inc. · KJJ · Apr 3, 2009 · DE

Device Facts

• Record ID: K082470
• Device Name: SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
• Applicant: Inter-Med, Inc.
• Product Code: KJJ · DE
• Decision Date: Apr 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRA™ are solutions used for debridement and the instrumentation of root canal. Sodium Hypochlorite-3% & 6% and Chlor-XTRA™ 6% are Sodium Hypochlorite in water.

Device Story

Endodontic irrigation solutions; 3% or 6% sodium hypochlorite in water. Chlor-XTRA™ variant includes wetting agents to reduce surface tension and alkalizing salt agents to increase electrical capacity. Used by dentists/endodontists during root canal procedures to facilitate cleaning and instrumentation. Applied directly to root canal system. Benefits include effective debridement and standard-of-care irrigation for endodontic therapy.

Clinical Evidence

No clinical data. Evidence consists of laboratory analyses and citations of published literature establishing sodium hypochlorite as the standard of care for root canal irrigation.

Technological Characteristics

Chemical solution; active ingredient sodium hypochlorite (3% or 6%) in water. Chlor-XTRA™ formulation includes wetting agents and alkalizing salts. Standalone liquid product. No software, electronics, or mechanical components.

Indications for Use

Indicated for root canal debridement and instrumentation in patients requiring endodontic treatment.

Predicate Devices

• Pulpdent Sodium Hypochlorite Solution (K0962743)
• Aquatine™ EC Endodontic Cleanser (K061689)
• ChlorCid Sodium Hypochlorite Solution (Class 1 Exempt)

Submission Summary (Full Text)

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K082470

Inter-Med, Inc. / Vista-Dental, Inc. 2200 Northwestern Ave., Ra:ine, WI 53404

## Section G

APR - 3 2009

# 510(k) Sunimary

| 510(k) Summary | This summary of 510(k) safety and effectiveness is being submitted in<br>accordance with the requirements of 21 CFR 807.92 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Inter-Med, Inc. / Vista-Dental, Inc.<br>2200 Northwestern Ave,<br>Racine, WI 53404 |
| Contact Person | Name and Title: George Horvat-QA/RA Manager<br>Ph: 262-636-9755<br>Fax: [phone] |
| Trade Name | Sodium Hypochlorite-3% & 6%<br>6% Sodium Hypochlorite with wetting agents marketed as<br>Chlor-XTRATM |
| Classification Name | Cleanser, Root Canal |
| Common Name | Endodontic Cleanser |
| Predicate Devices | Pulpdent Sodium Hypochlorite Solution, Pulpdent Corporation,<br>K09662743, AquatineTM EC Endodontic Cleanser; PuriCore, Inc.,<br>K061689; ChlorCid Sodium Hypochlorite Solution, Product Code<br>EKS, Class 1 Exempt from Premarket Notification, manufactured by<br>Ultradent Products, Inc., Registered Establishment # 1718912 |
| Description | Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% Sodium<br>Hypochlorite in water.<br>Sodium Hypochlorite 6% with wetting agents to lower surface tension<br>marketed as Chlor-XTRATM is a Sodium Hypochlorite solution in<br>water with alkalizing salt agents to increase the electrical capacity of<br>the solution. |
| Indications for Use | Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6%<br>with wetting agents to lower surface tension marketed as Chlor-<br>XTRATM are solutions used for debridement and the instrumentation<br>of root canal. Sodium Hypochlorite-3% & 6% and Chlor-XTRATM 6%<br>are Sodium Hypochlorite in water. |
| Substantial<br>Equivalence | The product is similar in function and intended use to:<br>- Pulpdent Sodium Hypochlorite Solution, manufactured by<br>Pulpdent Corporation, K0962743<br>- AquatineTM EC Endodontic Cleanser; manufactured by PuriCore, Inc., K061689<br>- ChlorCid Sodium Hypochlorite Solution, manufactured by<br>Ultradent Products, Inc. under Registered Establishment #<br>1718912, Product Code EKS, Class 1 Exempt from<br>Premarket Notification. |
| Performance | Laboratory analyses are provided in this premarket notification.<br>Sodium Hypochlorite is the standard of care for root canal irrigation.<br>Several published articles supporting this statement have been<br>included in this premarket notification. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and the public trust. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. George Horvat Quality Manager Inter-Med, Incorporated 2200 Northwestern Avenue Racine, Wisconsin 53404

APR - 8 2009

K082470 Re:

> Trade/Device Name: Sodium Hypochlorite 3% & 6% Solution Sodium Hypochlorite 6% with Wetting Agents to lower Surface Tension Marketed as Chlor-Xtra Regulation Number: 21 CFR Unclassified Regulation Name: None Regulatory Class: None Product Code: KJJ Dated: March 30, 2009 Received: March 30, 2009

Dear Mr. Horvat:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

Susan Kunan

Ginette Y. Michaud, M.D. Acting 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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## Indications for Use

70 510(k) Number (if known): == 0 8 2-4

Device Names:

- 1. Sodium Hypochlorite 3% & 6% Solution
- 1. Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-Xtra

### Indications for Use:

Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with Soulum Pryponionto o % uface tension marketed as Chlor-XTRA™ are welting agems to lower banalos ent and in the instrumentation of root canal. solum Hypochlorite 3% & 6% and Chlor-XTRA™ 6 % are Sodium Hypochlorite solutions in water.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/CR Over-The-Counter Use __
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Roeser

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

510(k) Number: K082470