(219 days)
K09662743, K061689
Not Found
No
The device description and intended use clearly define the product as a chemical solution for root canal procedures, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for debridement in root canals, which is a therapeutic action to treat a medical condition.
No
The document states the solutions are "used for debridement and the instrumentation of root canal," which are therapeutic or procedural actions, not diagnostic ones. It also mentions "Laboratory analyses are provided" and "Sodium Hypochlorite is the standard of care for root canal irrigation," further reinforcing its role in treatment rather than diagnosis.
No
The device description clearly states the device is a solution (liquid), which 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 for "debridement and the instrumentation of root canal." This is a procedure performed on the patient's body (specifically, within the root canal), not on a sample taken from the body for diagnostic purposes.
- Device Description: The device is a solution (Sodium Hypochlorite) used for irrigation and cleaning within the root canal. It's a therapeutic/procedural agent, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with Soulum Pryponionto o % uface tension marketed as Chlor-XTRATM are welting agems to lower banalos ent and in the instrumentation of root canal. solum Hypochlorite 3% & 6% and Chlor-XTRATM 6 % are Sodium Hypochlorite solutions in water.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
Device Description
Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% Sodium Hypochlorite in water.
Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM is a Sodium Hypochlorite solution in water with alkalizing salt agents to increase the electrical capacity of the solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory analyses are provided in this premarket notification. Sodium Hypochlorite is the standard of care for root canal irrigation. Several published articles supporting this statement have been included in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K09662743, K061689
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
accordance with the requirements of 21 CFR 807.92 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Inter-Med, Inc. / Vista-Dental, Inc.
2200 Northwestern Ave,
Racine, WI 53404 |
| Contact Person | Name and Title: George Horvat-QA/RA Manager
Ph: 262-636-9755
Fax: 262-636-9760 |
| Trade Name | Sodium Hypochlorite-3% & 6%
6% Sodium Hypochlorite with wetting agents marketed as
Chlor-XTRATM |
| Classification Name | Cleanser, Root Canal |
| Common Name | Endodontic Cleanser |
| Predicate Devices | Pulpdent Sodium Hypochlorite Solution, Pulpdent Corporation,
K09662743, AquatineTM EC Endodontic Cleanser; PuriCore, Inc.,
K061689; ChlorCid Sodium Hypochlorite Solution, Product Code
EKS, Class 1 Exempt from Premarket Notification, manufactured by
Ultradent Products, Inc., Registered Establishment # 1718912 |
| Description | Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% Sodium
Hypochlorite in water.
Sodium Hypochlorite 6% with wetting agents to lower surface tension
marketed as Chlor-XTRATM is a Sodium Hypochlorite solution in
water with alkalizing salt agents to increase the electrical capacity of
the solution. |
| Indications for Use | Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6%
with wetting agents to lower surface tension marketed as Chlor-
XTRATM are solutions used for debridement and the instrumentation
of root canal. Sodium Hypochlorite-3% & 6% and Chlor-XTRATM 6%
are Sodium Hypochlorite in water. |
| Substantial
Equivalence | The product is similar in function and intended use to:
- Pulpdent Sodium Hypochlorite Solution, manufactured by
Pulpdent Corporation, K0962743 - AquatineTM EC Endodontic Cleanser; manufactured by PuriCore, Inc., K061689
- ChlorCid Sodium Hypochlorite Solution, manufactured by
Ultradent Products, Inc. under Registered Establishment #
1718912, Product Code EKS, Class 1 Exempt from
Premarket Notification. |
| Performance | Laboratory analyses are provided in this premarket notification.
Sodium Hypochlorite is the standard of care for root canal irrigation.
Several published articles supporting this statement have been
included in this premarket notification. |
1
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.
2
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
3
Indications for Use
70 510(k) Number (if known): == 0 8 2-4
Device Names:
-
- Sodium Hypochlorite 3% & 6% Solution
-
- 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