(134 days)
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No
The document describes a dental composite material and its properties, with no mention of AI or ML technology.
No
The device is a restorative material for dental use (composite filling) and does not directly provide therapeutic benefits like healing or treating a disease. Its purpose is to restore the structure of a tooth.
No
Explanation: The device is described as a "visible light cured flowable composite" used as a "restorative" material (a filling material). Its intended use is to restore teeth, not to diagnose a condition.
No
The device is a flowable composite material, which is a physical substance used in dental restorations, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that PULPDENT FLOW-RITE is a "visible light cured flowable composite used as a Class II, III, IV and V restorative." This describes a material used directly on or in the patient's body for restorative purposes in dentistry.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are used outside the body.
- Device Description: The description reinforces that it's a material with specific physical properties (paste, light-cured, color stable, polishes beautifully) for use in dental procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, PULPDENT FLOW-RITE is a medical device, specifically a dental restorative material, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Pulpdent FLOW-RITE is a visible light cured flowable composite material. It dispenses as a smooth paste with excellent working properties and translucency for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully. Intended use: Class II, III, IV, and V restorations.
PULPDENT FLOW-RITE is a visible light cured flowable composite used a Class II, III, IV-and V restorative. It dispenses as a smooth paste with used as a Class if, III, I v ale 7 researcy for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully.
Product codes
EBF
Device Description
Pulpdent FLOW-RITE is a visible light cured flowable composite material. It dispenses as a smooth paste with excellent working properties and translucency for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Pulodent Hybrid Anterior Composite, Bisco Aeliteflo E&D / Kerr Revolution
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Ka71594
SEP 1 2 1997
EXHIBIT 8
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
DEVICE NAME: Pulpdent FLOW-RITE
Pulpdent OBA, Seal-Rite, Seal-Rite Low Viscosity, PREDICATE DEVICE: Pulodent Hybrid Anterior Composite Bisco Aeliteflo E&D / Kerr Revolution
DESCRIPTION AND INTENDED USE: Pulpdent FLOW-RITE is a visible light cured flowable composite material. It dispenses as a smooth paste with excellent working properties and translucency for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully. Intended use: Class II, III, IV, and V restorations.
COMPARISON WITH PREDICATE PRODUCTS: Pulpdent FLOW-RITE is substantially equivalent in composition and/or intended use to the above mentioned predicate products. Please see EXHIBIT 5 for the entire comparison.
SAFETY AND EFFECTIVENESS: According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...both composites and glass ionomers are relatively trouble free. There is no evidence of short or long term risk... there is no suspicion of any problems after literally billions of procedures in the United States." Please see EXHIBIT 6 for the complete papers from the conference.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 1997
Mr. Kenneth J. Berk Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02272
K971594 Re: Flow-Rite Trade Name: Requlatory Class: II Product Code: EBF Dated: July 14, 1997 Received: July 21, 1997
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, or to devices that have been reclassified 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 sections 531
2
Page 2 - Mr. Berk
through 542 of the Act for devices under the Electronic Chrough 542 Of the Act 101 acrises or other Federal laws or regulations.
This letter will allow you to begin marketing your device as This recei will arrow your of the motification. The FDA described in your 510 tr, premation of your device to a legally marketed predicate device results in a classification for your marketed predicate device robadewice to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advice i additionally 809.10 for in regulation (21 crk rares), please contact the Office of Villo draghosere actroob, , , , , , , , , , questions on Compilance at (301) 554 4010. In and advice, please contact che promocion and adversionig o1 (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene reger notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance oblained from ene brough (800) 638-2041 or (301) 443-6597 or at at its coll free namber (s://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Tim M. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
510(k) Number (if known): K9715-94
Device Name: PULPDENT FLOW-RITE
Indications For Use:
PULPDENT FLOW-RITE is a visible light cured flowable composite used a Class II, III, IV-and V restorative. It dispenses as a smooth paste with used as a Class if, III, I v ale 7 researcy for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K971594 |
| Prescription Use | Yes |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | No |
| (Optional Format 1-2-96) |