(16 days)
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Not Found
No
The provided 510(k) summary describes a dental filling material and its intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the material's application in dental procedures.
No
The device's intended uses, such as "Fillings of any minimally invasive cavity" and "Lining or coating cavities," describe procedures that restore or repair anatomical structures, which aligns with the definition of a therapeutic device.
No
The provided text describes uses related to restorative dentistry, such as filling cavities and repairing prosthetics. It does not mention any function for identifying or diagnosing diseases or conditions.
Unknown
The provided text is a 510(k) summary template with no information filled in the "Device Description" section. Without a description of the device, it is impossible to determine if it is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The listed intended uses are all related to dental procedures performed directly on a patient's teeth (fillings, sealing, lining, repairing). These are clinical procedures, not laboratory tests performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or laboratory equipment for analysis
The device appears to be a dental material or instrument used for restorative dentistry.
N/A
Intended Use / Indications for Use
- Fillings of any minimally invasive cavity
- Fillings of small cavities and extended fissure sealing
- Block out undercuts.
- Lining or coating cavities.
- Filling of cavities including V-shaped defects and cervical caries.
- Repair of fillings and veneers.
- Repair of filling of translucent prosthetic pieces, e.g., porcelain-only crowns.
Product codes
EBF
Device Description
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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
Not Found
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)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left and is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
JUL 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VOCO GmbH C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K051868
Trade/Device Name: Grandio Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 07, 2005 Received: July 11, 2005
Dear Mr. Shipps:
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.
1
Page 2 - Mr. Gerald W. Shipps
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA is issuance of a substance couries with requirements of the Act or
that FDA has made a determination that your device complies with must comply wit that FDA has made a determination that your develop with veness of T
any Federal statutes and regulations administered by other Federal are listing (2) CFR Part 807): any Federal statutes and regulations administered by one. I restation and listing (21 CFR Part 807);
all the Act's requirements, including, but not times to registration as s all the Act's requirements, including, but normance requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as set forth labeling (21 CFR Part 801); good manufacturing jraeticable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic prod systems (QS) regulation (21 CF CF CF 2 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
Career and and the Bangle of any for het stick as wivelenes of your device to Al This letter will allow you to oegill marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of y premarket notification. The FDA Inding of substantial equiralette of 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 If you desire specific advice for your de vice of our as Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the contact the Office of Compliance at (240) 270-01-12 13:48 Pat 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21 Cfree of Small "Misbranding by relefence to premailities under the Act from the Division of Small general information on your responsibilities and at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistanto a real of the result industry/support/index.html.
Sincerely yours,
Suttle y. Michael O.m.D
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Image /page/2/Picture/2 description: The image shows a sequence of digits, specifically the number 1051868. The digits are handwritten and appear to be in black ink. The numbers are spaced closely together and are of varying sizes.
Device Name: GRANDIO FLOW
Indications for Use:
- Fillings of any minimally invasive cavity ●
- Fillings of small cavities and extended fissure sealing ●
- Block out undercuts .
- Lining or coating cavities .
- Elling of couling vincluding V-shaped defects and cervical caries .
- Repair of fillings and veneers ●
- Repair of filling of translucent prosthetic pieces, e.g., porcelain-only crowns .
X AND/OR Prescription Use _ (Part 21 CFR 801 Subpart D)
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)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K051868
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