(86 days)
PRO-V is line of provisional restorative materials designed to address the differing requirements for creating or placing any provisional restoration. The PRO-V System consists of PRO-V FLO, PRO-V FILL, and PRO-V COAT which offers a complete solution to create an effective inlay or onlay provisional.
Indications for Use:
- Temporary fillings
- Provisional Inlays
- Provisional Onlays
PRO-V is line of provisional restorative materials designed to address the differing requirements for creating or placing any provisional restoration. The PMO-V System consists of PRO-V FLO, PRO-V FII.1, and PRO-V COAT. PRO-V FLO™ is a flowable composite for use as a provisional for inlay restorations. PRO-V FILL™ is a packable composit: for use as a provisional for onlay restorations. PRO-V COATTM is a separating agent.
The provided text describes the PRO-V Temporary/Provisional Filling Material, a dental cement, and its substantial equivalence to a predicate device (E-Z Temp). However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, the document details a 510(k) premarket notification for the PRO-V device, indicating that it has been deemed "substantially equivalent" to a legally marketed predicate device (E-Z Temp). This substantial equivalence is based on comparisons of intended use, chemical composition, and mechanical/physical properties, along with biocompatibility testing.
Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics are not present in this submission.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" against specific thresholds. Instead, it presents a comparative table between the applicant device (PRO-V) and the predicate device (E-Z Temp) to establish substantial equivalence.
| Characteristic | Predicate Device (E-Z Temp) | Applicant Device (PRO-V) |
|---|---|---|
| Intended Use | Provisional Inlay and Onlay Restorative | Provisional Inlay and Onlay Restorative |
| Chemical Composition | Light-cured, glass filled, resin based inlay and onlay composite supplied with a water-soluble separating agent | Light-cured, glass filled, resin based inlay and onlay composite supplied with a water-soluble separating agent |
| Mechanical / Physical Properties | E-Z Temp Inlay: Low viscosity dispensable composite E-Z Temp Onlay: High viscosity sculptable composite E-Z Temp Separating Agent: Water-soluble separating agent | PRO-V FLO: Low viscosity, dispensable composite PRO-V FILL: High viscosity sculptable composite PRO-V COAT: Water-soluble separating agent |
| Biocompatibility | Not explicitly stated for E-Z Temp in this table, but assumed to be acceptable as a legally marketed predicate. | Tested and found to be non-toxic. |
"Acceptance Criteria" for Substantial Equivalence: The implicit acceptance criterion here is that PRO-V's characteristics (intended use, chemical composition, and physical/mechanical properties) are sufficiently similar to those of E-Z Temp, and that PRO-V is found to be non-toxic, such that it poses no new or different questions of safety and effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions that "PRO-V was tested for biocompatibility." No details on the sample size for this testing are provided. The broader comparison is conceptual and based on product descriptions, not a specific clinical or performance test set.
- Data Provenance: Not specified. It's implied the biocompatibility testing was conducted by or for Bisco, Inc. (USA), but no country of origin for the data is explicitly stated. The nature of the comparison is based on product specifications rather than observational data.
- Retrospective or Prospective: Not applicable as no specific study involving a test set is detailed. The substantial equivalence argument is based on product descriptions and documented biocompatibility.
3. 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)
Not applicable. No "ground truth" establishment by experts for a test set is described. The comparison is based on technical specifications and biocompatibility testing report reviewed by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method described as no specific test set requiring such expert review is mentioned.
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 dental material, 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 dental material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the conventional sense of establishing ground truth for diagnostic performance. The "truth" for substantial equivalence is based on the characteristics of the predicate device and the new device's compliance with these characteristics (e.g., chemical composition, physical properties, non-toxicity).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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Ko73263
Page 5-1
FEB 1 4 2008
Section 5 510 (k) SUMMARY
Applicant: Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193 Contact Person: Benjamin Lichtenwalner Tel: 847-534-6146 Fax: 847-534-6111 November 19, 2007 Date Prepared: PRO-V Trade Name: Temporary/Provisional Filling Material Common Name:
Dental Cement
Description of Applicant Device:
Classification/Name:
PRO-V is line of provisional restorative materials designed to address the differing requirements for creating or placing any provisional restoration. The PMO-V System consists of PRO-V FLO, PRO-V FII.1, and PRO-V COAT. PRO-V FLO™ is a flowable composite for use as a provisional for inlay restorations. PRO-V FILL™ is a packable composit: for use as a provisional for onlay restorations. PRO-V COATTM is a separating agent.
Class II per 21 CFR 872.3275
Intended uses of Applicant Device:
The PRO-V COAT is easily applied to an adhesive coated tooth surface before temporization with PRO-V FI.O or PRO-V FILL for provisional inlay or onlay cestorations. The PRO-V COAT provides a barrier between the applied adhesive resin and provisional fi ling materials. The PRO-V FLO or PRO-V FILL can then be easily removed when no longer needed and the PRO-V COAT is simply rinsed off with copious amounts of water.
Predicate Devices: E-Z Temp cleared under (K924) 32) dated July 8, 1993.
Significant Performance Characteristics:
| E-Z Temp | PRO-V | |
|---|---|---|
| Intended use | Provisional Inlay and Onlay Restorative | Provisional Inlay and Onlay Restorative |
| Chemicalcomposite | Light-cured, glass filled, resin based inlayand onlay composite supplied with a water-soluble separating agent | Light-cured, glass filled, resin basedinlay and onlay composite supplied witha water-soluble separating agent |
| Mechanical /Physicalproperties | E-Z Temp Inlay: Low viscositydispensable compositeE-Z Temp Onlay: High viscositysculptable compositeE-Z Temp Separating Agent: Water-soluble separating agent | PRO-V FLO: Low viscosity,dispensable compositePRO-V FILL: High viscosity sculptablecompositePRO-V COAT: Water-solubleseparating agent |
SUBSTANTIAL EQUIVALENCE SUMMARY
Side by side comparisons of PRO-V to the predicate device E-Z Temp clearly demonstrates that the applicant device is substantially equivalent to the legally marked device. PRO-V was tested for hiocompatibility and it was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of PINO-V.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Image /page/1/Picture/3 description: The image shows the date February 14, 2008. The month is represented by the abbreviation FEB. The day is 14 and the year is 2008. The text is in a sans-serif font and is black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Benjamin Lichtenwalner Regulatory Affairs Manager Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K073263
Trade/Device Name: PRO-V Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: November 19, 2007 Received: November 20, 2007
Dear Mr. Benjamin Lichtenwalner:
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. Benjamin Lichtenwalner
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Supt. y. Michael Davis.
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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510 (k) Number (if known):
Device Name: PRO-V
Indications for Use Statement:
PRO-V is line of provisional restorative materials designed to address the differing I KV-V is fine of provisional restorational restoration. The PRO-V System requirements for creating of practing u.J., and PRO-V COAT which offers a complete solution to create an effective inlay or onlay provisional.
Indications for Use:
- Temporary fillings A.
- Provisional Inlays B.
- Provisional Onlays (.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/CIR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suen Runn
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Ancola Dental Devices
510(k) Number: __
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.