(67 days)
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No
The document describes a composite restoration material and a fabrication system, with no mention of AI or ML technology.
No
The device is a composite restoration material used for fabricating crowns and bridges, which are restorative rather than therapeutic in nature. It replaces missing tooth structure but does not treat a disease.
No.
The device is a composite restoration material used for fabricating dental crowns and bridges, not for diagnosing medical conditions.
No
The device description clearly states it is a "composite restoration material" and is part of a "crown and bridge fabrication system" which includes a "belleGlass HP automatic curing device." These are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that belleGlass Point 4 is a "composite restoration material use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges." This describes a material used in the fabrication of dental prosthetics, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description further clarifies that it's a "composite restoration material" used in a dental laboratory setting to create crowns and bridges.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information about belleGlass Point 4 does not mention any such testing or analysis of biological samples.
Therefore, based on the provided information, belleGlass Point 4 is a dental material used in the fabrication of dental restorations, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
belleGlass Point 4 is a composite restoration material use with the helleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure.
Product codes (comma separated list FDA assigned to the subject device)
EBD
Device Description
belieGlass Point 4 is a composite restoration material use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure. The belleGlass HP crown and bridge fabrication system is comprised of all the components necessary for a dental laboratory to fabricate composite resin-based crowns and bridges and cure them using both light activation combined with a final heat and pressure curing cycle in the belleGlass HP automatic curing device.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Image /page/0/Picture/0 description: The image shows a date, "MAY 0 6 2003". The month is May, the day is the 6th, and the year is 2003. The text is in a bold, sans-serif font. The text is black against a white background.
SYBRON DENTAL SPECIALTIES Section III - 510(k) Summary of Safety and Effectiveness
KO3OH6
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
February 2003 Date Summary Prepared:
Device Name:
- Trade Name belleGlass Point 4 .
- Common Name Dual Cured Indirect Composite Restorative Material ও
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, belleGlass HP Enamel 2 .
- Kerr Corporation, belleGlass HP Translucent Dentin .
Device Description:
belieGlass Point 4 is a composite restoration material use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure. The belleGlass HP crown and bridge fabrication system is comprised of all the components necessary for a dental laboratory to fabricate composite resin-based crowns and bridges and cure them using both light activation combined with a final heat and pressure curing cycle in the belleGlass HP automatic curing device.
Intended Use of the Device:
The intended use of belleGlass Point 4 is to be used with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure.
Substantial Equivalence:
belleGlass Point 4 is substantially equivalent to other legally marketed devices in the United States. belleGlass Point 4 functions in a manner similar to and is intended for the same use as the original belleGlass HP Enamel 2 and belleGlass HP Translucent Dentin formulation that are currently manufactured by Kerr Corporation.
1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400
1
Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with wavy lines below them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 6 2003
Kerr Dental Material Center C/O Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867
Re: K030646
Trade/Device Name: belleGlass Point 4 Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: February 26, 2003 Received: February 28, 2003
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 ihe 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 - Ms. Colleen Boswell
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 (OS) 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. 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) you may obtain. 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.
Suser Punreo
Susan Runner, DDS, MA Interim 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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Section I
Indications for Use Statement
Ver/3-4/24/96
Applicant: Kerr Dental Materials Center
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K030646 |
| Device Name: | belleGlass Point 4 |
Indications For Use:
belleGlass Point 4 is a composite restoration material use with the helleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure.
(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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
| Labels | Values |
|---|---|
| 510(k) Number: | K203 0646 |