(129 days)
Ultradent UltraCid and UltraCid F, Ultradent Concepsis, Dental Therapeutics AB Tubulicid Plus, Tubulicid Blue Label, Tubulicid Red Label
Not Found
No
The description focuses on a chemical cleansing product and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The product is described as a "dental product used to cleanse and moisten cavity preparations," and its primary function is to prepare the tooth for sealing or bonding, potentially reducing microleakage sensitivity. This function is preventative or preparatory for restoration, rather than directly treating a disease or restoring a health condition.
No
The device is described as a "dental product used to cleanse and moisten cavity preparations," indicating a therapeutic or preparatory function rather than a diagnostic one. It does not identify or detect a disease or condition.
No
The device description clearly indicates a physical dental product used for cleansing and moistening cavity preparations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cleanse and moisten cavity preparations in teeth. This is a direct application to the patient's body (specifically, their teeth) during a dental procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples from the body.
- Device Description: The description reinforces its use as a topical dental product applied directly to the tooth structure.
- Lack of Diagnostic Information: The device's function is to prepare the tooth surface, not to diagnose a condition or provide information about a patient's health status based on a sample.
Therefore, Pulpdent CAVITY CLEANSER is a dental device used for treatment/preparation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pulpdent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration.
Product codes (comma separated list FDA assigned to the subject device)
GBH
Device Description
Pullodent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration.
Pulpdent CAVITY CLEANSER PLUS combines all the features of Pulpdent CAVITY CLEANSER with the addition of sodium fluoride.
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)
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.
Ultradent UltraCid and UltraCid F, Ultradent Concepsis, Dental Therapeutics AB Tubulicid Plus, Tubulicid Blue Label, Tubulicid Red Label
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
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
510 k Premarket Notification
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be 'K974202'. The handwriting is somewhat messy, and the characters are not perfectly formed, but they are still legible. The image is in black and white.
EXHIBIT 2
MAR 1 9 1998
RESPONSE TO SMDA OF 1990
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown. MA 02272-0780 USA TELEPHONE: (617) 926-6666 (617) 926-6262 FAX:
PULPDENT Cavity Cleanser and DEVICE NAME: PULPDENT Cavity Cleanser Plus
Ultradent UltraCid and UltraCid F PREDICATE DEVICES: Ultradent Concepsis Dental Therapeutics AB Tubulicid Plus Tubulicid Blue Label Tubulicid Red Label
DESCRIPTION AND INTENDED USE:
Pullodent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration.
Pulpdent CAVITY CLEANSER PLUS combines all the features of Pulpdent CAVITY CLEANSER with the addition of sodium fluoride.
COMPARISON WITH PREDICATE PRODUCTS: Pulpdent CAVITY CLEANSER and CAVITY CLEANSER PLUS are substantially equivalent in composition and intended use to the predicate products. Please see Exhibit 4 for the entire comparison.
SAFETY AND EFFECTIVENESS: The materials that make up these products are accepted by the Council on Dental Therapeutics and have been used safely in dental products for decades. Please see Exhibit 8 for the complete references,
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 1998
Mr. Kenneth J. Berk ·Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02272
Re : K974202 Pulpdent Cavity Cleanser, Pulpdent Cavity Trade Name: Cleanser Plus Regulatory Class: III Product Code: ГВН Dated: January 29, 1998 Received: February 3, 1998
Dear Mr. Berk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to-895. A ------substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
2
Page 2 - Mr. Berk
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Reqister, pages 43442-43455 (copy Be advised that under Section 519(e) of the Act as enclosed). amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). 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 (301) 443-6597, or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain).html" .
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): _ K 974202__________________________________________________________________________________________________________________________________________
CAVITY CLEANSER Device Name: PULPDENT
Indications I-or Usc:
DESCRIPTION AND INTENDED USE:
Pulpdent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEDI
Concurrence of CORH, Office of Device Evaluation (ODE)
| Susan Runner | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974262 |
| Prescription Use | Over-The-Counter Use | |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |