CHX=CHX PLUS

K112250 · Inter-Med, Inc. · KJJ · Oct 28, 2011 · DE

Device Facts

• Record ID: K112250
• Device Name: CHX=CHX PLUS
• Applicant: Inter-Med, Inc.
• Product Code: KJJ · DE
• Decision Date: Oct 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

CHX and CHX-Plus™ are used as a final endodontic rinse after instrumentation to irrigate and cleanse the root canal system for long lasting cleansing

Device Story

CHX and CHX-Plus are 2% chlorhexidine gluconate solutions; CHX-Plus includes wetting agents to reduce surface tension. Used as endodontic cleansers in dental clinics by dentists/endodontists. Delivered into the root canal space via irrigating needle following instrumentation. Cleansing occurs through mechanical action of solution moving through the canal system. Removes debris; prepares canal for filling. Benefits include effective canal cleansing.

Clinical Evidence

Bench testing only. Biocompatibility and efficacy demonstrated via non-clinical studies. No clinical data provided.

Technological Characteristics

2% chlorhexidine gluconate solution in water. CHX-Plus formulation includes surfactants (wetting agents) to lower surface tension. Liquid form factor for delivery via irrigating needle. Non-sterile/sterile status not specified; chemical composition consistent with existing dental irrigation products.

Indications for Use

Indicated for use as a final endodontic rinse following instrumentation to irrigate and cleanse the root canal system in patients undergoing endodontic procedures.

Predicate Devices

• Endo-CHX (K070401)
• QMix 2inl Endodontic Irrigating Solution (K103244)
• Consepsis (K924982)
• BioPure MTAD Root Canal Cleanser (K053167)
• Aquatine EC Endodontic Cleanser (K061689)

Submission Summary (Full Text)

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K112250

Image /page/0/Picture/2 description: The image shows the logo for Intermed Inc. The logo features the word "intermed" in bold, black letters, with a line underneath. To the right of the word is a black and white globe. The letters "INC." are in smaller, black letters to the right of the globe.

Inter-Med, Inc. 2200 Northwestern Avenue Racine, WI 53404 [phone] (voice) [phone] (fax)

# SECTION G

## 510(k) Summary

| 510(k) Summary | This summary of 510(k) safety and effectiveness is<br>being submitted in accordance with the requirements<br>of 21 CFRF 807.92 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Inter-Med, Inc / Vista-Dental, Inc.<br>2200 Northwestern Ave.<br>Racine, WI 53404 |
| Contact Person | Name and Title: John Baeten, Engineering Manager<br>Ph: 262-636-9755<br>Fax: [phone] |
| Date Prepared | July 27, 2011 |
| Proprietary Name | • CHX<br>• CHX-PlusTM |
| Classification Name | Cleanser, Root Canal |
| Common Name | Endodontic Cleanser |
| CFR Number | N/A |
| Device Class | Unclassified |
| Product Code | KJJ |
| Predicate Device(s) | K070401, Endo-CHXTM Root Canal Cleanser,<br>Essential Dental Systems, Inc.<br>K103244, QMixTM 2inl Endodontic Irrigating Solution,<br>DENTSPLY International<br>K924982, ConsepsisTM, Ultradent Products, Inc.<br>K053167, BioureTM MTADTM Root Canal Cleanser,<br>DENTSPLY International<br>K061689, AquatineTM EC Endodontic Cleanser,<br>PuriCore, Inc. |
| Description | CHX and CHX-PlusTM are 2% Chlorhexidine<br>Gluconate Solutions in water. CHX – PlusTM also<br>contains wetting agents to lower surface tension. CHX<br>and CHX-PlusTM are root canal cleansers for use in<br>endodontic procedures. After endodontic<br>instrumentation, these products should be used to<br>cleanse the canal space before placement of the<br>endodontic filling. The material should be delivered<br>into the canal using an irrigating needle |
| Indications for Use | CHX and CHX-Plus™ are used as a final endodontic<br>rinse after instrumentation to irrigate and cleanse the<br>root canal system for long lasting cleansing |
| Substantial<br>Equivalence | CHX and CHX-Plus™ are identical to the predicates<br>since they irrigate and cleanse via the mechanical<br>action of the solution moving through the root canal<br>system. |
| | Both CHX-Plus™ and Endo-CHX™ are combination<br>products containing 2% chlorhexidine digluconate with<br>surfactant(s). These items are identical in active<br>ingredient (i.e. 2% chlorhexidine digluconate) and<br>indications for use. |
| | Both CHX-Plus™ and Consepsis™ are combination<br>products containing 2% chlorhexidine digluconate and<br>surface active agents to lower surface tension. CHX-<br>Plus™ contains surfactants and Consepsis™ contains<br>ethyl alcohol. |
| | CHX / CHX-Plus™, Endo-CHX™, Consepsis™, and<br>QMix™ 2inl Endodontic Irrigating Solution are all root<br>canal cleansers containing chlorhexidine digluconate. |
| | CHX-Plus™, Endo-CHX™, QMix™ 2inl Endodontic<br>Irrigating Solution, and BioPure™MTAD™ are all root<br>canal cleansers containing a surfactant to lower<br>surface tension. |
| Non-clinical<br>Performance | The performance and biocompatibility data provided<br>support the safety and effectiveness of CHX and CHX-<br>Plus™ for the indicated uses. All components found in<br>CHX and CHX-Plus™ have been used in legally<br>marketed devices. The efficacy and biocompatibility<br>was demonstrated via non-clinical studies. |
| Conclusion | CHX and CHX-Plus™, to be manufactured by Inter-<br>Med Inc., are substantially equivalent to the currently<br>cleared and marketed predicates and raise no issues<br>of safety and effectiveness. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

OCT 2 8 2011

Mr. John Baeten Engineering Manager Inter-Med, Inc. 2200 Northwestern Avenue Racine, WI 53404

Re: K112250

Trade/Device Name: CHX and CHX-Plus™ Regulation Number: None Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Codes: KJJ Dated: July 27, 2011 Received: August 4, 2011

Dear Mr. Baeten:

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. Baeten:

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 device-related 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.

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 /ucm 115809.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 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 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 to!

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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Inter-Med, Inc., 2200 Northwestern Ave, Racine, W! 53404

### Indications for Use

11/2250 510(k) Number (if known):

### Device Names:

1. CHX

2. CHX-Plus™

### Indications for Use:

CHX and CHX-Plus™ are used as a final endodontic rinse after instrumentation to irrigate and cleanse the root canal system for long lasting cleansing

Prescription Use _ Over-The-Counter Use X Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (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)

Susan Runner

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

510(k) Number:

F-2