(56 days)
Kerr Corporation, belleGlass HP Modeling Resin
Not Found
No
The 510(k) summary describes a dental modeling gel and does not mention any AI or ML components or functionalities.
No
The device is described as a filled resin used as a pre-wetting agent for placing and sculpting layers of composites, intended to make processing restorations easier, faster, and improve quality. It is a material used in the dental restoration process, not a device that provides therapy or treatment for a disease or condition.
No
Explanation: The device is described as a pre-wetting agent for placing and sculpting layers of composites, and its purpose is to make the processing of restorations easier and faster, improving quality. There is no mention of the device being used to identify or characterize a disease, condition, or health status.
No
The device description clearly states it is a "filled resin" and a "gel," indicating 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 belleGlass HP Modeling Gel is a "filled resin used as a pre-wetting agent for placing and sculpting layers of composites." This describes a material used in the mouth during a dental procedure.
- Device Description: The description further elaborates on its function in facilitating the placement and sculpting of composite restorations. It discusses its composition and how it improves the handling and quality of dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are typically used to test samples like blood, urine, tissue, etc., to diagnose or monitor medical conditions. This device is a material used directly in a dental procedure on a patient.
N/A
Intended Use / Indications for Use
The intended use of belleGlass HP Modeling Gel is to be used as a pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite.
belleGlass HP Modeling Gel is a filled resin used as a pre-wetting agent for placing and sculpting layers of composites and it is to be used between layers of cured composite.
Product codes
EBF
Device Description
belleGlass HP Modeling Gel will make the processing of the belleGlass restorations easier and faster and will improve the quality of the restorations by making the system more user friendly. belleGlass HP Modeling Gel is 50% filled with fine radiopaque reinforcing fillers of 0.4micron average particle size. The gel is similar to "flowable composites" and will assure a strong intimate bond between composite layers as well as reducing the chances of dilution of the enamel and dentin surfaces. By using the belleGlass HP Modeling Gel, surfaces will be less sticky, making it easier to sculpt and after processing easier to polish. The results are closer margins, stronger restorations, and savings of time increasing productivity.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Kerr Corporation, belleGlass HP Modeling Resin
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white.
MAR 1 5 2002
BRON DENTAL SPECIALTIES
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: January 2002
Device Name:
- Trade Name belleGlass HP Modeling Gel .
- Common Name Modeling Gel .
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .
Devices for Which Substantial Equivalence is Claimed:
- . Kerr Corporation, belleGlass HP Modeling Resin
Device Description:
belleGlass HP Modeling Gel will make the processing of the belleGlass restorations easier and faster and will improve the quality of the restorations by making the system more user friendly. belleGlass HP Modeling Gel is 50% filled with fine radiopaque reinforcing fillers of 0.4micron average particle size. The gel is similar to "flowable composites" and will assure a strong intimate bond between composite layers as well as reducing the chances of dilution of the enamel and dentin surfaces. By using the belleGlass HP Modeling Gel, surfaces will be less sticky, making it easier to sculpt and after processing easier to polish. The results are closer margins, stronger restorations, and savings of time increasing productivity.
Intended Use of the Device:
The intended use of belleGlass HP Modeling Gel is to be used as a pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite.
Substantial Equivalence:
belleGlass HP Modeling Gel is substantially equivalent to other legally marketed devices in the United States. The product marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a black and white circular logo. The logo features the emblem of the U.S. Department of Health & Human Services in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2002
Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K020178
Trade/Device Name: belleGlass HP Modeling Gel Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 15, 2002 Received: January 18, 2002
Dear Ms. Boswell:
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 - Ms. Colleen Boswell
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) 594-4659. 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,
Timothy A. Ulatowski
Timo Ky A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I
Indications for Use Statement
Ver/ 3 - 4/24/96
Applicant: Kerr Dental Material Center
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K020178 |
Device Name: belleGlass HP Modeling Gel
Indications For Use:
belleGlass HP Modeling Gel is a filled resin used as a pre-wetting agent for placing and
sculpting layers of composites and it is to be used between layers of cured composite.
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| Labels | Values |
|---|---|
| 510(k) Number | K020178 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
4
Section I
Indications for Use St.
Ver/ 3 - 4/24/96
Applicant: Kerr Dental Material Center
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K020178 |
| Device Name: | belleGlass HP Modeling Gel |
Indications For Use:
belleGlass HP Modeling Gel is a filled resin used as a pre-wetting agent for placing and
sculpting layers of composites and it is to be used between layers of cured composite.
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| Labels | Values |
|---|---|
| ODA Number | K020178 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.119)
(Optional Format 1-2)