(804 days)
Not Found
Not Found
No
The provided text describes a device for cleaning and preparing tooth surfaces using a stream of particles. 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 mechanical function and intended uses of the device.
Yes.
The device's intended uses, such as "Cleaning of Tooth Surfaces Stain Removal," "Removal of Surface Deposits from Toeth," "Preparation of tooth surfaces for sealants," "Repair of composite, acrylic and ceramic restorations," and "Class I-V cavity preparation," directly relate to the treatment or amelioration of conditions or the restoration of structure and function in dental care.
No
The device description focuses on "Cleaning," "Removal," "Preparation," "Microciding," "Polishing," "Repair," and "Occlusal adjustments." These are all therapeutic or preparatory procedures, not diagnostic ones. There is no mention of identifying, detecting, or assessing a condition.
No
The provided text describes a device for cleaning and preparing tooth surfaces using a controlled stream of particles, which strongly suggests a hardware-based device (e.g., an air abrasion unit) rather than software alone. The description of the device itself is missing, but the intended use points to a physical intervention.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to mechanical procedures performed directly on tooth surfaces and dental materials within the mouth. These are not tests performed on samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
- Device Description: While the description is "Not Found," the listed uses strongly suggest a device that physically interacts with the teeth and dental materials.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a dental device used for procedures within the oral cavity, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
General Usage:
Cleaning of Tooth Surfaces
Stain Removal from Tooth Surfaces
Removal of Surface Deposits from Toeth
Cleaning of Dental Pits and Fissures
Microciching of enamel and dentin surfaces in preparation for adhesive bonding procedures
Microciding of enamer and deching and etching) of metallic, ceramic, composite and actylic surfaces for dental procedures including bonding, cementation, repair and restoration
Delivers a controlled stream of particles for the removal of tooth structure
Specific Dental Usage:
Preparation of tooth surfaces for sealants
Preparation of tooth surfaces for orthodontic bracket bonding
Preparation of tooth surfaces for bonding bridges
Preparation of internal root surfaces for post procedures (after root canal therapy)
I reparation of tooth surfaces for adhesive bonding procedures, ceramic inlays, crowns and bridges
Preparation of root surfaces for periodontal procedures
Repair of composite, acrylic and ceramic restorations
Occlusal adjustments and equilibration
Repair of prosthetic appliances
Bonded splint procedures
Removal of cement from temporary and permanent procedures
Class I-V cavity preparation
NOT FOR USE ON AMALGAM
Product codes
KOJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth Surfaces, Dental Pits and Fissures, enamel and dentin surfaces, internal root surfaces, root surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
Not Found
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2000
Nicholas G. Levandoski, Ph.D. President IRT Management Corporation 470 Ansin Boulevard, Suite G Hallandale, Florida 33009
Re : K980672 BioStar Airbrator Trade Name: Regulatory Class: II Product Code: KOJ Dated: February 18, 1998 Received: February 20, 1998
Dear Dr. Levandoski:
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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of
1
Page 2 - Dr. Levandoski
the Act for devices under the Electronic Product Radiation the Act for devices andor end rederal laws or regulations.
This letter will allow you to begin marketing your device as first it do will be market notification. The FDA described in your siet... puivalence of your device to a legally Finding of subbeaneral ogaresults in a classification for your marketed predicate device robates as a see as the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regulacion (21 crx rares), please contact the Office of Vicio diagnobero ac (301) 594-4692. Additionally, for questions on Compilance at (501) 591 ising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be Information on your rision of Small Manufacturers Assistance obcained from the biving (800) 638-2041 or (301) 443-6597 or at at Its coll-free namber (000)- 050 - 05 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
Sincerely yours,
Timothy Ulatowski
atowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Pagc 1 of __ l
510(k) Number (if known): K980672
Device Name: SIMPLEXTM AIRBRATORTM
Indications For Use:
General Usage:
Cleaning of Tooth Surfaces Stain Removal from Tooth Surfaces Removal of Surface Deposits from Toeth Cleaning of Dental Pits and Fissures Cleaning of Dental I its and Fissures
Microciching of enamel and dentin surfaces in preparation for adhesive bonding procedures Microciding of enamer and deching and etching) of metallic, ceramic, composite and actylic surfaces for dental procedures including bonding, cementation, repair and restoration Delivers a controlled stream of particles for the removal of tooth structure
Specific Dental Usage: Preparation of tooth surfaces for sealants Preparation of tooth surfaces for orthodontic bracket bonding Preparation of tooth surfaces for bonding bridges Preparation of internal root surfaces for post procedures (after root canal therapy) I reparation of tooth surfaces for adhesive bonding procedures, ceramic inlays, crowns and bridges Preparation of root surfaces for periodontal procedures Repair of composite, acrylic and ceramic restorations Occlusal adjustments and equilibration Repair of prosthetic appliances Bonded splint procedures Removal of cement from temporary and permanent procedures Class I-V cavity preparation
NOT FOR USE ON AMALGAM
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K980672 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |