(238 days)
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No
The provided text describes a dental primer and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a dental primer used for adhesion between dental metal and resin materials, which does not actively treat or prevent a disease or condition for therapeutic benefit.
No
The device is described as a metal-adhesive primer used to promote adhesion in dental procedures, not to diagnose a condition. Its uses are all related to fabrication, repair, and bonding of dental materials.
No
The device is a metal-adhesive primer, which is a physical substance used in dental procedures. This is a 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 clearly describes a product used to promote adhesion between dental materials (metal and resin) for fabrication and repair of dental restorations and appliances. This is a direct application within the oral cavity or on dental materials outside the body, but not for testing biological samples to diagnose or monitor a medical condition.
- 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
- Measuring biomarkers or analytes
- Being used in a laboratory setting for testing
The device is a dental material used in the process of creating and repairing dental prosthetics and restorations. This falls under the category of a dental device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
M.L. Primer is a metal-adhesive primer to promote adhesion between dental metal and composite resins or acrylic resins. M.L. Primer is intended for use for the following:
- Used when fabricating and repairing resin facing crowns.
- Used when fabricating and repairing resin veneered crowns.
- Used when repairing porcelain fused to metal crowns.
- Used when fabricating and repairing denture base with metal plate, metal clasp or metal attachments.
- Used for bonding metal restorations (inlays, onlays, crowns and bridges), metal orthodontic bands and metal splints to tooth structure using adhesive resin cement or used for their repair.
Product codes
KLE
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2004
Mr. David P. Morais Operations Manager Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92069
Re: K040079
Trade/Device Name: M.L. Primer Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 3, 2004 Received: September 7, 2004
Dear Mr. Morais:
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 (1) 1) vice 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. Mr. Mr. Morais
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DTS issualles or abat your device complies with other requirements Incall that I DA nas made a actessions regulations administered by other Federal agencies. of the Act of ally I ederal statutes and regarments, including, but not limited to: registration You must comply with an are riseeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), lasting (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ion 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) This letter will anon you to ought time of substantial equivalence of your device to a premarket nothleadon. The First matts 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 specific advice for your de at (301) 594-4613. 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 from the may obtain other general meetirs, International and Consumer Assistance at its toll-free Dryison (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Chiu Lin, Ph.D.
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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Indications for Use
510(k) Number (if known): K040079
Device Name: M.L. Primer
Indications For Use:
M.L. Primer is a metal-adhesive primer to promote adhesion between dental metal and
esses of the supportunes and to are are are are are liv M.C. Phiner 13 a moter a intra- or extra-orally.
M.L. Primer is intended for use for the following:
- Used when fabricating and repairing resin facing crowns. .
- Used when rabneating and repairing and repairing crowns. .
- Used when repairing porcelain rased to faung crown.
Used when fabricating and repairing denture base with metal plate, metal clasp . or metal attachments. - or metal attachments.
Used for bonding metal restorations (inlays, onlays, crowns and bridges), metal
e super of bonding metal restorations (indecive resin coment or . Used for bonding metal restorations (imays) cadhesive resin cement or splints, metal poolo on hand used for their repair.
Susan Rinn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042771
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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)
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