(22 days)
["K990176"]
Not Found
No
The device is a chemical solution for dental procedures and the summary contains no mention of AI or ML.
Yes
The device is used for lavage and debridement of root canals, which are therapeutic medical interventions.
No
Explanation: The device is a solution used for lavage, debridement, and irrigation of root canals during instrumentation, which are therapeutic and procedural functions, not diagnostic ones.
No
The device is a chemical solution (sodium hypochlorite) and not a software product. The description clearly states it is a liquid used for dental procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "lavage and debridement of root canals and as an irrigant for root canal instrumentation." This is a direct treatment or procedural use within the body (specifically, the root canal system of a tooth).
- Device Description: The description confirms it's a solution used for these procedures.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. IVDs are typically used to analyze blood, urine, tissue, or other bodily fluids or samples.
Therefore, this device falls under the category of a therapeutic or procedural device used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hypochlorite solution used for lavage and debridement of root canals and as an irrigant for root canal instrumentation.
Product codes
KJJ
Device Description
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hypochlorite solution used for root canal lavage and debridement and as an irrigant for root canal instrumentation. Pulpdent SODIUM HYPOCHLORITE SOLUTION is 5.25 % sodium hvochlorite in water.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Premier Hypogen Union Broach Sodium Hypochlorite Solution
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be a combination of a lowercase letter and numbers. The string reads 'K962743'.
EXHIBIT 7
RESPONSE TO SMDA OF 1990
SIOUK SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02272-0780 USA
TELEPHONE: (617) 926-6666 FAX: (617) 926-6262
PULPDENT Sodium Hypochlorite Solution DEVICE NAME:
PREDICATE DEVICE: Premier Hypogen Union Broach Sodium Hypochlorite Solution
DESCRIPTION AND INTENDED USE:
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hvpochlorite solution used for root canal lavage and debridement and as an irrigant for root canal instrumentation. Pulpdent SODIUM HYPOCHLORITE SOLUTION is 5.25 % sodium hvochlorite in water.
COMPARISON WITH PREDICATE PRODICTS:
Pulpdent SODIUM HYPOCHLORITE SOLUTION is substantially equivalent in composition and intended use as the predicate products. Please see Exhibit 5 for the entire companison.
SAFETY AND EFFECTIVENESS:
According to the American Dental Association Council on Accepted Dental Therapeutics: "Sodium hypochlorite solution has a solvent action on pulp tissue and organic debris, and is used for irrigation of root canals. Aqueous solutions of 2.5 percent and 5 percent sodium hypochlorite are reportedly equally effective in dissolving pulpal debris when used as root canal irrigants." Sodium hypochlorite solution is considered safe in concentrations less than 7.5 percent and when applied to intact tissue. Please see Exhibit 6 for the entire citation.
40
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and a curved line representing its tail. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a semi-circle above the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 1996
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02272
K962743 Re : Pulpdent Sodium Hypochlorite Solution Trade Name: Regulatory Class: Unclassified Product Code: KJJ July 9, 1996 Dated: July 15, 1996 Received:
Dear Mr. Berk:
We have reviewed your Section 510(k) notification of incent to we have reviewed your Becced. bove and we have determined the market the acvroutially equivalent (for the indications for use stated in the enclosure) to devices marketed in interestate commerce prior to May 28, 1976, the enactment date of the Commerce prior comments or to devices that have been Medical Beviet in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major be subject to back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with Subscancearly agturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (GMF) regulacion (2) Crod and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP vertify such asbampelonin regulatory action. In addition, FDA may publish further announcements concerning your device in may publical Register. Please note: this response to your the rederal Regioner ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . prematier noctricacion on under sections 531 through 542 of obligation you might have the Electronic Product Radiation the Act for devices under one acceal Laws or Regulations.
2
Page 2 - Mr. Berk
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Olin S. E. Jr.
Timothy a. Ulatowski
Timothy A. Ulatowsk Acting Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page, l of 1
510(k) Number (if known): Suprom Device Name: PUL P D EN T Hypochlo Indications For Use:
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hypochlorite solution used for lavage and debridement of root canals and as an irrigant for root canal instrumentation. ased to: 12735 EN 000100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE): |
|---|
| --------------------------------------------------------- |
| (Division Sign-Off) | Susan Keasey |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K96162743 |
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)