(64 days)
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No
The summary describes a dental cement for orthodontic bands and appliances, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is a material for cementing orthodontic bands and appliances, which is a supportive role in a medical procedure, not a therapeutic intervention itself.
No
This device is a cement used for bonding orthodontic bands and appliances, not for diagnosing medical conditions.
No
The intended use describes a paste for cementation, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cementation of orthodontic bands and appliances. This is a procedure performed directly on a patient's teeth, not on a sample of human origin (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status, disease, or condition.
- Using reagents or assays.
Therefore, GC Fuji ORTHO BAND PASTE PAK falls under the category of a dental device used for a restorative or orthodontic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GC Fuji ORTHO BAND PASTE PAK is intended to be used for cementation of orthodontic bands. It is also used for the cementation of appliances retained with stainless steel crowns. I.e. Herbst or expansion appliances.
Product codes
DYH
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
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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
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§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2002
Ms. Terry L. Joritz Director, Regulatory Affairs & Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K020578
Trade/Device Name: GC Fuji ORTHO BAND PASTE PAK Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH Dated: February 19, 2002 Received: February 21, 2002
Dear Ms. Joritz:
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.
1
Page 2 - Ms. Terry L. Joritz
You must comply with all the Act's requirements, including, but not limited to: registration Tourinust comply with and Hood Log (21 CFR Part 801); good manufacturing practice allo listing (21 CF RT art 807), labeling (21 CFR Part 820); and if requirents as set form in are quality six 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 I ins leter will anow you to cognization of substantial equivalence of your device to 310(k) promises noticate 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 If you desire up only 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the aller databliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Comphilance wee, 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 notheation (21 OF ICP art 0011).
the Act may be obtained from the Division of Small Manufacturers, International and the receiner 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,
Susan Runner
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
GC Fuii ORTHO BAND PASTE PAK Device Name:_
Indications For Use:
GC Fuji ORTHO BAND PASTE PAK is intended to be used for cementation of GCT the ONND PAOTE : It is also used for the cementation of appliances retained with stainless steel crowns. I.e. Herbst or expansion appliances.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96).
Susan Rumm
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices, 510(k) Number_100 (1)