(149 days)
No
The summary describes a chemical cleanser for root canals and does not mention any computational or data-driven components.
No
The device is a root canal cleanser, used for irrigation and cleansing, which supports a procedure but does not directly treat or prevent a disease or condition in a therapeutic manner beyond cleansing.
No
This device is described as a "root canal cleanser" used to "irrigate and cleanse root canal systems" and "cleanse the canal space before placement of the endodontic filling." Its function is therapeutic/preparatory, not diagnostic.
No
The device description clearly states it is a "root canal cleanser" and a "material" delivered using an "irrigating needle," indicating it is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "irrigate and cleanse root canal systems." This is a procedure performed directly on the patient's body (in vivo), not on a sample taken from the body (in vitro).
- Device Description: The description confirms it's a "root canal cleanser for use in endodontic procedures" and is "delivered into the canal using an irrigating needle." This further reinforces its in-vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely therapeutic/procedural within the body.
N/A
Intended Use / Indications for Use
Endo-CHXTM is intended to irrigate and cleanse root canal systems.
ENDO-CHX™ is intended to irrigate and cleanse root canal systems.
Product codes
KJJ
Device Description
Endo-CHX™ is a root canal cleanser for use in endodontic procedures. After endodontic instrumentation, the product should be used to cleanse the canal space before placement of the endodontic filling. The material should be delivered into the canal using an irrigating neede. A side-vented, closed tip irrigation needle is most preferred.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Testing:
The performance and biocompatibility documentation provided the submission support the safety and effectiveness of the Endo-CHX root canal cleanser for the indicated uses.
Clinical Testing:
Not applicable
Key Metrics
Not Found
Predicate Device(s)
K061689, AquatineTM EC Endodontic Cleanser, PuriCore, Inc.
K053167, BioPureTM MTADTM Root Canal Cleanser, Dentsply International
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Exhibit #2
JUL 1 1 2007
Image /page/0/Picture/3 description: The image is a logo for Essential Dental Systems (EDS). The logo is black and white and features the letters "EDS" in a bold, blocky font on the left side. To the right of the letters, the words "ESSENTIAL DENTAL SYSTEMS" are stacked vertically in a smaller, sans-serif font. The entire logo is enclosed in a rounded rectangle with a thin black border. There is a registered trademark symbol on the top right corner of the rounded rectangle.
( € APPROVED PRODUCTS
89 Leuning Street S. Hackensack New Jersey 07606
1(800) 22-FLEXI Tel.: (201) 487-9090 Fax: (201) 487-5120
| 510(k) Summary | |
|---|---|
| Name and address of sponsor of the | |
| 510(k) submission: | Essential Dental Systems, Inc. |
| 89 Leuning Street | |
| South Hackensack, NJ 07606 | |
| Official contact person for all | |
| correspondence: | Brian Rasimick |
| Phone: 201-487-9090 | |
| Fax: 201-487-5120 | |
| E-mail: brasimick@edsdental.com | |
| Date Prepared: | June 26, 2007 |
| Device Name: | Endo-CHXTM |
| Generic name of the device: | Root Canal Cleanser |
| Classification, Product Code and | |
| CFR Regulation Number: | Unclassified, Product Code KJJ |
| Classification Panel: | Dental |
| Predicate Device Names and 510(k) | |
| numbers: | K061689, AquatineTM EC Endodontic Cleanser, PuriCore, Inc. |
| K053167, BioPureTM MTADTM Root Canal Cleanser, Dentsply International |
Device Description:
Endo-CHX™ is a root canal cleanser for use in endodontic procedures. After endodontic instrumentation, the product should be used to cleanse the canal space before placement of the endodontic filling. The material should be delivered into the canal using an irrigating neede. A side-vented, closed tip irrigation needle is most preferred.
1
Comparison with Predicate Device:
Both Endo-CHX "M and Aquatine" EC irrigate and cleanse via the mechanical action of the solution moving through the root canal system.
Both Endo-CHX™ and BioPure™ MTAD™ are combination products containing a drug component.
Endo-CHX™ is an aqueous solution of 2% chlorhexidine digluconate with surfactant and coloring. Aquatine™ EC is an aqueous hypochlorite solution (hypochlorous acid). BioPure™ MTAD™ is an aqueous doxycycline solution with citric acid and surfactant.
Intended Use:
Endo-CHXTM is intended to irrigate and cleanse root canal systems.
Non-Clinical Testing:
The performance and biocompatibility documentation provided the submission support the safety and effectiveness of the Endo-CHX root canal cleanser for the indicated uses.
Clinical Testing:
Not applicable
Conclusion:
In our opinion, Endo-CHXTM is substantially equivalent to the predicates and raises no issues of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is an emblem that resembles an eagle.
JUL 1 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Essential Dental Systems, Incorporated C/O Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K070401
Trade/Device Name: ENDO-CHX TM Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: KJJ Dated: June 27, 2007 Received: July 3, 2007
Dear Ms. Goldstein-Falk:
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.
3
Page 2 -- Ms. Goldstein-Falk
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 (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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit #1
INDICATIONS FOR USE
Page 1 of 1
510(k) Number (if known):
Device Name: ENDO-CHX™
Indications for Use:
ENDO-CHX™ is intended to irrigate and cleanse root canal systems.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K070461