(75 days)
Not Found
Not Found
No
The device description and intended use clearly state it is a cleaning solution, and there is no mention of AI, ML, image processing, or any other computational technology.
No
The device is a cleaning solution used in a treatment procedure, but it does not directly provide therapy or diagnostic information. Its function is to prepare the anatomical site for subsequent treatment.
No
The device is described as a cleaning solution for root canals, not a tool for diagnosing medical conditions.
No
The device description clearly states that SmearClear is a "cleaning solution," which is a chemical substance and not software.
Based on the provided information, SmearClear is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to clean root canals within the body (in vivo) prior to a dental procedure (obturation).
- Device Description: The description reinforces its use as a cleaning solution for root canals.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease.
IVDs are typically used to test samples like blood, urine, tissue, etc., in a laboratory setting to diagnose or monitor conditions. SmearClear is a topical solution applied directly to a part of the body during a dental procedure.
N/A
Intended Use / Indications for Use
The intended use of SmearClear is designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Indications For Use: SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
Device Description
SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
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)
Not Found
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.
Not Found
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
Image /page/0/Picture/0 description: The image is a logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized font, with a curved line above the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are written in a serif font. The logo is black and white.
MAR 0 5 2003
KO24198
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: December 2002
Device Name:
- Trade Name SmearClear .
- Common Name Endodontic Irrigating Solution .
- Classification Name Root Canal Cleanser .
Devices for Which Substantial Equivalence is Claimed:
- PulpDent Corporation, PulpDent's EDTA Solution .
Device Description:
SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Intended Use of the Device:
The intended use of SmearClear is designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Substantial Equivalence:
Smear Clear is substantially equivalent to other legally marketed devices in the United States. SmearClear functions in a manner similar to and is intended for the same use as PulpDent's EDTA Solution manufactured by PulpDent Corporation.
1
Image /page/1/Picture/11 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 5 2003
Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867
Re: K024198
Trade/Device Name: SmearClear Regulation Number: Unclassified Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: December 18, 2002 Received: December 20, 2002
Dear Ms. Boswell:
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
Page 2 – Ms. Colleen Boswell
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Roanes
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I
Indications for Use Statement
Ver/3-4/24/96
Applicant: Sybron Endo, a division of Ormco Corporation
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K024198 |
| Device Name: | SmearClear |
Indications For Use:
SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the
walls of root canals prior to obturation.
Ken Muky for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| Labels | Values |
|---|---|
| 510(k) Number. | K024198 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)