(134 days)
PULPDENT FLOW-RITE is a visible light cured flowable composite used as a Class II, III, IV and V restorative. 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.
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.
The provided document describes a 510(k) submission for a dental device, "Pulpdent Flow-Rite," a visible light-cured flowable composite material. However, the document does not contain the specific information requested regarding acceptance criteria or a dedicated study proving the device meets those criteria.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and referencing a general NIH Technology Assessment Conference on the safety of dental restorative materials.
Here's a breakdown of why I cannot provide the requested information from the given text:
- No specific acceptance criteria are listed.
- No detailed study protocol or results are presented. The document refers to general knowledge about dental restorative materials' safety but doesn't detail a study conducted specifically for Pulpdent Flow-Rite to prove its performance against quantifiable criteria.
Therefore, for each point you requested, the answer derived solely from this document is that the information is not provided:
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A table of acceptance criteria and the reported device performance:
- Information Not Provided: The document does not specify any quantifiable acceptance criteria (e.g., bond strength, wear resistance, dimensional stability thresholds) for Pulpdent Flow-Rite, nor does it present specific performance data from a dedicated study against such criteria.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Information Not Provided: The document does not describe a test set, sample sizes, or data provenance for any specific study related to Pulpdent Flow-Rite's performance. The safety and effectiveness statement references a general NIH conference on dental materials, not a study performed for this specific device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Information Not Provided: Since no specific test set or study for performance is detailed, there's no mention of experts establishing ground truth for such a test.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Information Not Provided: No test set or adjudication method is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Information Not Provided: This device is a dental restorative material, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information Not Provided: This device is a physical dental material, not an algorithm. Standalone algorithm performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Information Not Provided: No specific study with ground truth establishment is described for Pulpdent Flow-Rite. The safety statement is based on general clinical usage of similar materials over time as discussed in an NIH conference.
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The sample size for the training set:
- Information Not Provided: No training set is applicable or described, as this is a physical medical device, not a machine learning model.
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How the ground truth for the training set was established:
- Information Not Provided: Not applicable, as there is no training set described.
Summary of Device Information Provided:
- Device Name: Pulpdent FLOW-RITE
- Intended Use: Class II, III, IV, and V restorations.
- Description: Visible light-cured flowable composite material, smooth paste, excellent working properties and translucency, cures in 30-40 seconds, color stable, polishes beautifully.
- Predicate Devices: Pulpdent Hybrid Anterior Composite, Bisco Aeliteflo, E&D / Kerr Revolution.
- Safety and Effectiveness Justification: Based on substantial equivalence to predicate devices and general consensus from an NIH Technology Assessment Conference on the high benefit-to-risk ratio and "relatively trouble free" nature of composites and glass ionomers over 20 years of general usage, with "no evidence of short or long term risk."
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials with predefined acceptance criteria for every new product. The provided document aligns with this regulatory pathway.
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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.
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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
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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
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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) |
§ 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.