(83 days)
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Zircon-F Prophylaxis Paste
The provided text is a 510(k) summary for the Zircon-F Prophylaxis Paste. It focuses on establishing substantial equivalence to predicate devices rather than presenting performance data from a specific study against predefined acceptance criteria. Therefore, most of the requested information about device performance, study details, and ground truth establishment is not available in the provided document.
Here's an attempt to answer based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report device performance in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "performance" assessment is implicitly an assessment of sameness in intended use, technological characteristics, and materials.
| Acceptance Criteria (Implicitly based on Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same Intended Use as predicate devices | Met: Zircon-F Prophylaxis Paste has the same intended use: "for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment" as cleared 510(k) devices. |
| Same Technological Characteristics as predicate devices | Met: "The technological characteristics for this product are the same as those for the predicate devices and other paste products currently on the market except for minor variations in the same or similar components." |
| Substantially Equivalent Materials to predicate devices | Met: "Descriptive information provided shows that the materials from which Pascal Co., Inc.'s Zircon-F Prophylaxis Paste is made are substantially equivalent (nearly identical with some) to those of similar products, used for identical purposes, currently on the market." The document explicitly references "Oral cavity abrasive polishing paste" (CFR 872.6030) as the originally classified device and lists specific 510(k) cleared products (K033449, K024343, K000169) as predicate devices for comparison. |
2. Sample sized used for the test set and the data provenance
Not applicable. The document does not describe a performance study with a test set. The assessment is based on a comparison to predicate devices and their established characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is described as there is no specific performance study.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication method described.
5. 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
Not applicable. This device is a prophylaxis paste, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device (prophylaxis paste), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for a performance study. The "truth" in this context is the regulatory determination of substantial equivalence based on comparison to existing predicate devices' intended use, technological characteristics, and materials.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned.
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JUL - 7 2004
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and symbols. The sequence starts with what appears to be the letter 'K', followed by the number '0', a symbol resembling the Greek letter 'psi', and then the numbers '0988'. The handwriting style is somewhat cursive, with the numbers and symbols connected in a fluid manner.
Image /page/0/Picture/2 description: The image shows the logo for Pascal Company, Inc. The logo consists of a stylized, rounded "L" shape on the left, followed by the word "Pascal" in a bold, sans-serif font. Underneath "Pascal" is the phrase "Company, Inc." in a smaller font, with a line separating it from the word above. The logo is simple and professional in appearance.
WATS 800/426-805
IX. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (AS REQUIRED BY SECTION 807.92C)
| 1) | Submitted by: | Vincent M. Tentarelli |
|---|---|---|
| Pascal Company, Inc. | ||
| 2929 NE Northup Way | ||
| Bellevue, WA 98004 | ||
| USA | ||
| 2) | Establishment Registration No.: | 3011632 |
| 3) | Date Prepared: | April 12, 2004 |
| 4) | Device Trade Name: | Zircon-F Prophylaxis Paste |
| 5) | Device Common Name | Prophylaxis Paste |
| 6) | Device Classification Name: | Oral cavity abrasive polishing paste |
| 7) | Device Class: | Class I |
- Substantial equivalence: Zircon-F Prophylaxis Paste is substantially equivalent to the દર) originally classified device described in CFR 872.6030, "Oral cavity abrasive polishing paste." It is also substantially equivalent and nearly identical to (for example ) the following products that are currently on the market, having been cleared by 510(k)s:
| 510(k) Number | Name of Device | Company |
|---|---|---|
| K033449 | Double-Pro | Professional Dental |
| K024343 | Butler Gum Prophy Paste | USBiomaterials Corp. |
| K000169 | Nupro Prophylaxis Paste | Dentsply Intl. |
-
- The document, "Guidance on the CDRH Premarket Notification Review Program, June 30, 1986 (K86-3)" was used to determine substantial equivalence:
- a) Zircon-F Prophylaxis Paste has the same intended use, for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment, as many cleared by the 510(k) process as shown above.
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- The technological characteristics for this product are the same as those for the b) predicate devices and other paste products currently on the market except for minor variations in the same or similar components.
- Descriptive information provided shows that the materials from which Pascal c) Co., Inc.'s Zircon-F Prophylaxis Paste is made are substantially equivalent (nearly identical with some) to those of similar products, used for identical purposes, currently on the market.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines, representing the department's focus on people and their well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2004
Mr. Vincent M. Tentarelli Quality Assurance Manager Pascal Company, Incorporated P.O. Box 1478 Bellevue, Washington 98009-1478
Re: K040988
Trade/Device Name: Zircon-F Prophylaxis Paste Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: April 12, 2004 Received: April 20, 2004
Dear Mr. Tentarelli:
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.
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Page 2 - Mr. Tentarelli
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. 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 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 vours.
Carls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VII. STATEMENT OF INDICATIONS FOR USE
. ·
841 510 (k) NUMBER (IF KNOWN): J ZIRCON-F PROPHYLAXIS PASTE DEVICE NAME: INDICATIONS FOR USE:
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Swan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Denta 510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.