(77 days)
Not Found
Not Applicable
No
The summary describes a device for cutting and preparing tooth structure, similar to a predicate device that is a microetcher. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is used for cutting and preparing tooth structure, as well as roughening/etching tooth surfaces for adhesive restorative procedures. These are procedural steps rather than direct therapeutic treatments, and the device itself does not deliver a therapeutic agent or effect.
No
The intended use describes the device’s function as cutting and preparing tooth structure, removing composite restorations, and roughening/etching tooth surfaces for adhesive procedures. These are all active treatment or preparatory functions, not diagnostic ones.
No
The 510(k) summary describes a device for cutting and preparing tooth structure, removing composite restorations, and roughening/etching tooth surfaces. The intended use and predicate device (Microetcher AP/PrepStar™) strongly suggest a physical device, likely involving abrasive technology, rather than a software-only solution. There is no mention of software, image processing, AI, or any other characteristic typically associated with a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed directly on the tooth structure (cutting, preparation, removal, roughening, etching). These are physical manipulations of the tooth.
- Anatomical Site: The anatomical site is the tooth structure itself.
- Lack of In Vitro Testing: There is no mention of testing samples of biological material (like blood, urine, tissue, etc.) outside of the body. IVDs are designed to perform tests on these types of samples.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- No Mention of Biological Samples: The description of the intended use and anatomical site focuses solely on the tooth structure itself, not on analyzing biological samples derived from the patient.
Therefore, this device is a dental instrument used for direct treatment of the tooth, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Cutting and Preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite restorations. For roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures.
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 structure, enamel, dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists Only.
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.
Microetcher AP/PrepStar™ by Danville Engineering Inc.
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
§ 872.6080 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2003
Mr. Barry B. Groman President Groman Incorporated 1917 NW 80 Avenue Margate. Florida 33063
Re: K030292
Trade/Device Name: Groman PrepMaster™ Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: KOJ Dated: January 27, 2003 Received: January 28, 2003
Dear Mr. Groman:
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. Groman
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) 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 regulation (21 CFR Part 801), please contact the Office of Compliance 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 Division of Small Manufacturers, International and Consumer 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 vours.
Suren Sunner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page Page Ca of of of
510(k) Number (if known): _
Groman PrepMaster™ Device Name:
Indications For Use:
Cutting and Preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite restorations. For roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures.
Indications for use are identical to Microetcher AP/PrepStar™ by Danville Engineering Inc.
For Use by Dentists Only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Susan OR Phaver
Over-The-Counter Use
Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number K030292