(84 days)
Not Found
No
The device description and intended use are for a dental sealant with a chemical composition, and there is no mention of AI, ML, or any data processing capabilities.
No
The device is described as a sealant for dental restorations and appliances, which is a supportive function and not directly therapeutic in nature. Its purpose is to seal and protect, not to treat or cure a disease or condition.
No
The device is described as a sealant for dental restorations and appliances, and its purpose is to protect these surfaces, not to diagnose medical conditions.
No
The device description clearly states the device is a liquid material supplied in a bottle and applied with a brush, indicating it is a physical substance, not software.
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 the device is used to "SEAL THE SURFACE OF" various dental and prosthetic materials. This is a direct application to materials and surfaces, not for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the chemical composition and how it is applied to seal surfaces. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes
- Using reagents for testing
The device is a dental material used for sealing and protecting surfaces, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
TO SEAL THE SURFACE OF:
DIRECT COMPOSITE RESTORATIONS INDIRECT COMPOSITE RESTORATIONS AMALGAM RESTORATIONS INTRACORONAL SPLILNTS EXTRACORONAL SPLINTS LINGUAL RETAINERS ENAMEL SURFACES AROUND ORTHODONTIC BRACKETS PROVISIONAL RESTORATIONS PROCESSED ACRYLIC PROSTHESES-REMOVABLE PARTIAL & COMPLETE DENTURES AND MAXILLOFACIAL PROSTHESES PROCESSED ACRYLIC APPLIANCES-ORTHODONTIC RETAINERS
Product codes
EBD
Device Description
UNINHIBITED contains Hexafunctional Urethane Acrylate (30.6%), Polyethylene Glycol (400) Diacrylate (61.4%), phosphine oxide, diphenyl (Photoinitiator) 8.0% 4-methyl methacrylate (Inhibitor) 500 ppm. It is supplied in a bottle. It is applied with a brush to seal the surface of a composite restoration.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The ingredients of UNINHIBITED were tested for biocompatibility and were found to be non-toxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
AUG 01 2002
Section 5-1
Image /page/0/Picture/3 description: The image shows the logo for BISCO, a company specializing in adhesive and composite technology. The logo consists of six hexagons arranged in a zig-zag pattern. Each hexagon contains a letter, spelling out the company name "BISCO".
Image /page/0/Picture/5 description: The image shows a handwritten text string. The string appears to be "K021503". The characters are written in a simple, somewhat stylized manner, with some connections between the letters and numbers. The image is in black and white, with the text standing out against the white background.
Bisco, Inc.
1100 W. Irving Park Road, Schaumburg, IL. 60193 U.S.A Telephone: (847) 534-6000 or 1-800-BIS-DENT Fax: (847) 534-6396 WEB SITE http://www.bisco.com
Contact: Stephen D. Smith
SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 190 and 21 CFR par 807.92
Trade Name: Common Name: Classification name:
UNINHIBITED
Surface Sealant Material, Tooth Shade, Resin
Class II per 21 CFR 872.3690
Description of Applicant Device:
UNINHIBITED contains Hexafunctional Urethane Acrylate (30.6%), Polyethylene Glycol (400) Diacrylate (61.4%), phosphine oxide, diphenyl (Photoinitiator) 8.0% 4-methyl methacrylate (Inhibitor) 500 ppm. It is supplied in a bottle. It is applied with a brush to seal the surface of a composite restoration.
Intended uses of Applicant Device:
The principle use of UNINHIBITED is to seal the surface of:
Direct Composite Restorations, Indirect Composite Restorations, Provisional Restorations, Amalgam Restorations, Enamel Surfaces around Orthodontic Brackets, Processed Acrylic Prostheses-Removable Partial & Complete Dentures and Maxillofacial Prostheses, Processed Acrylic Appliances-Orthodontic Retainers, Lingual Retainers and Extracoronal Splints
Predicate Devices: Fortify K882915 cleared by FDA on 08/12/88 Significant Performance Characteristics:
| UNINHIBITED | FORTIFY | |
|---|---|---|
| Intended Use | Resin sealant. | Resin sealant. |
| Product | ||
| Description | Clear solution. | Clear solution. |
| Delivery System | Brush | Brush |
Side by side comparisons of UNINHIBITED to the predicate device FORTIFY clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of UNINHIBITED were tested for biocompatibility and were found to be non-toxic.
It is concluded that the information supplied in this submission has proven the safety and efficacy of UNINHIBITED.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 01 2002
Mr. Stephen Smith Manager of Regulatory Affairs Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K021503
Trade/Device Name: Uninhibited Regulation Number: 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: May 07, 2002 Received: May 09, 2002
Dear Mr. Smith:
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.
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.
2
Page 2 - Mr. Smith
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Timothe A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
of Sec. 2
| V UT | |||
|---|---|---|---|
| 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ | t | 1 | |
Device Name: UNINHIBITED
Indications For Use: TO SEAL THE SURFACE OF:
DIRECT COMPOSITE RESTORATIONS INDIRECT COMPOSITE RESTORATIONS AMALGAM RESTORATIONS INTRACORONAL SPLILNTS EXTRACORONAL SPLINTS LINGUAL RETAINERS ENAMEL SURFACES AROUND ORTHODONTIC BRACKETS PROVISIONAL RESTORATIONS PROCESSED ACRYLIC PROSTHESES-REMOVABLE PARTIAL & COMPLETE DENTURES AND MAXILLOFACIAL PROSTHESES PROCESSED ACRYLIC APPLIANCES-ORTHODONTIC RETAINERS
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Susan Purre
(Division Sign-Off) Division of Dental, Infection Control, a - Caneral Hospital Devices 1 Number _ 1000 30