(68 days)
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No
The device description and performance studies focus on the physical properties of acrylic materials, with no mention of AI/ML or related concepts like image processing or data analysis.
No
This device is described as a material for relining and repairing dentures, which is a restorative and prosthetic function, not a therapeutic one. It does not actively treat or prevent a disease or condition.
No
This device is described for "relining, repairing Denture" and its components are polymers and monomers. The intended use is for fabrication of dental appliances, not for diagnosis of medical conditions.
No
The device description explicitly lists physical components (Jet Acrylic Liquid-Monomer, Ortho Jet Powder Trade Name: Polymer, Plastic) which are 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 "relining, repairing Denture". This describes a process performed on a physical object (a denture) outside of the body, not a diagnostic test performed on a biological sample.
- Device Description: The device consists of "Jet Acrylic Liquid-Monomer" and "Ortho Jet Powder Trade Name: Polymer, Plastic". These are materials used for fabrication and repair, not reagents or instruments for analyzing biological samples.
- 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 patient's health status
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry.
The device is clearly intended for use in a dental setting for the physical manipulation and repair of dentures, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The commercial market for my dental products is solely going to be in the dental laboratory/dental office industry. Methyl methacrylate monomer and polymer is used to form a hard acrylic plastic during the fabrication of dental appliances.
- Orthodontic and Dental laboratories:
a. to be used by qualified dental/orthodontic technicians trained in the fabrication of orthodontic and pedodontic, fixed and removable appliances.
b. trained in the proper use, precautions and hazards of dental resins
c. the actual fabrication of these dental devices must first be preceded by an authorized prescription for such a device, by a licensed dental practitioner. - Dental Offices/Clinics
a. to be used by qualified dentists/dental assistants trained in the fabrication of orthodontic, pedodontic fixed and removable appliances.
b. to be used by qualified dentists/dental assistants trained in the proper use, precautions and hazards of dental resins
c. to be used under the direct supervision of a licensed dental practitioner
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Jet Acrylic Liquid-Monomer, Ortho Jet Powder Polymer, Plastic
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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Qualified dental/orthodontic technicians in orthodontic and dental laboratories; Qualified dentists/dental assistants in dental offices/clinics, under the direct supervision of a licensed dental practitioner.
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)
All the monomers and polymers were subjected to all of the tests listed above in the premarket submission for physical characteristics and performances that would be consistent and/or different with the other commercially marketed monomers and polymers tested. The none clinical tests, simple as they were, appeared to show results that represented equal performances between the TESTER samples and the CONTROL samples. The physical wearing of dental appliances by family members showed no immediate or short terms side affects from any of the new polymers or monomers.
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.
Not Found
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).
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
K9747:7
人的心
FEB 2 4 1998
510K SUMMARY
Since all JBC's proposed monomers and polymers are products using the same chemical formulas and in some cases the same polymers and monomers as other currently manufactured and distributed denture based resins, it is the dyes and pigments that are an issue here.
All the monomers and polymers were subjected to all of the tests listed above in the premarket submission for physical characteristics and performances that would be consistent and/or different with the other commercially marketed monomers and polymers tested. The none clinical tests, simple as they were, appeared to show results that represented equal performances between the TESTER samples and the CONTROL samples.
All solvent dyes used, were used at percentages that were allowable for maintaining safe FDA levels of toxic ingredients. The same also applies for the use of the dry synthetic dye pigments used to tint the polymers.
Therefore, all pigments used, were used, where levels of toxic substances were acceptable and regarded as not to be a threat to public safety.
The physical wearing of dental appliances by family members showed no immediate or short terms side affects from any of the new polymers or monomers.
I had inquired with the Dental Division of the Food And Drug Administration and asked about obtaining leach testing for each of my products to determine the safeness of the dyes/pigments. I was told that the dyes/pigments would not leach out of the cured methyl methacrylate resin. but if any free nitrogen electrons/ions, present in the dyes/pigments could transfer to the soft tissues of the mouth.
I was instructed to include in my 510K Summary the chemical structures of the dyes/pigments being used in my products. Therefore, the chemical structures that I was able to obtain are included for that part of your review. The chemical structures that I
1
KA 741727
was unable to obtain are of proprietary property and can be obtained upon request from the dye/pigment manufacturer(s).
Any further steps towards the manufacturing or production, await acceptance from the Food and Drug Administration, Center for Devices and Radiological Health, for the manufacturing and marketing of the above mentioned products.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in black lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1998
Ms. Priscilla L. Mier Co-Owner J.B.C. & Company 23691 Via Del Rio Yorba Linda, California 92887
Re : K974727 Jet Acrylic Liquid-Monomer, Ortho Jet Powder Trade Name: Polymer, Plastic Regulatory Class: II Product Code: EBI December 16, 1997 Dated: December 18, 1997 Received:
Dear Ms. Mier:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895: A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Ms. Mier
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricio Cusenite/for
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
02/13/98 12:02
2301 827 4349
ODE DGRD
Q 002
of 2 Page
510(k) Number (if known): __ 1 974727 edining, repairing Denture I Device Name:_
Indications For Use:
See Enclosure...
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sueen Qunner
(Division Sign-On) (Division of Dentel Infection Control, and General Host
510(k) Numoer
Prescription Use WE (Per 21 CFR 801. 109)
OR
Over-The-Counter Use No
(Optional Format 1-2-96)
5
PAGE 03
510K #
K974727
page 2/2
STATEMENT OF INTENDED USE
COMMERCIAL MARKET:
Because of the restricted nature of all dental resins, the commercial market for my dental products is solely going to be in the dental laboratory/dental office industry.
Methyl methacrylate monomer and polymer is used to form a hard acrylic plastic during the fabrication of dental appliances.
- Orthodontic and Dental laboratories: 1.
a. to be used by qualified dental/orthodontic technicians trained in the fabrication of orthodontic and pedodontic, fixed and removable appliances.
b. trained in the proper use, precautions and hazards of dental resins
c. the actual fabrication of these dental devices must first be preceded by an authorized prescription for such a device, by a licensed dental practitioner.
- Dental Offices/Clinics 2.
a. to be used by qualified dentists/dental assistants trained in the fabrication of orthodontic, pedodontic fixed and removable appliances.
b. to be used by qualified dentists/dental assistants trained in the proper use, precautions and hazards of dental resins
c. to be used under the direct supervision of a licensed dental practitioner