(86 days)
K924) 32
Not Found
No
The summary describes a line of dental restorative materials and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a provisional restorative material (temporary filling/restoration), which falls under general dental devices and not specifically therapeutic devices that treat a disease or condition. Its function is to temporarily restore, not therapeutically treat.
No
The device description and indications for use clearly state that PRO-V is a line of provisional restorative materials for temporary fillings, inlays, and onlays, which are therapeutic and restorative functions, not diagnostic. There is no mention of it being used to detect, diagnose, or monitor any condition.
No
The device description clearly states that PRO-V is a line of "provisional restorative materials" consisting of "flowable composite," "packable composite," and a "separating agent." These are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description of PRO-V clearly states it is a "provisional restorative material" used for "temporary fillings, provisional inlays, and provisional onlays." These are materials placed in the mouth to restore teeth, not used to test samples from the body.
- The intended use and device description focus on dental restoration. There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
- The performance study mentioned is biocompatibility. This is relevant for materials placed in the body, not for diagnostic tests.
Therefore, PRO-V falls under the category of a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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 (.
Product codes
EBG
Device Description
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.
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
PRO-V was tested for hiocompatibility and it was found to be non-toxic.
Key Metrics
Not Found
Predicate Device(s)
E-Z Temp cleared under (K924) 32)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 |
| Chemical | ||
| composite | 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 |
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.
1
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.
2
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
3
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: __