(98 days)
Not Found
No
The description focuses on a mechanical airbrush device and does not mention any AI or ML components or functionalities.
No
The device is used for cutting, preparing, and cleaning dental surfaces, which are procedural steps rather than direct therapeutic actions to treat a disease or condition. Its function is primarily in the preparation of the dental site for restorative procedures.
No
The device description and intended use/indications for use only mention "cutting and preparation" and "removal" of various dental materials, which are functional or procedural steps rather than diagnostic activities.
No
The device description explicitly states it is a "dental airbrush using aluminum oxide," which is a physical hardware device, not software.
Based on the provided information, the PrepAir is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- PrepAir's Intended Use: The PrepAir's intended use is for preparing teeth and dental materials in the mouth (in vivo) for dental procedures. It's a tool used directly on the patient's tissues and existing dental work.
- Device Description: The description confirms it's a dental airbrush used for preparing cavities and surfaces, which is a direct dental treatment procedure.
The PrepAir is a dental device used for direct patient care, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The PrepAir is intended for the cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
Product codes (comma separated list FDA assigned to the subject device)
KOJ
Device Description
The PrepAir is a dental airbrush using aluminum oxide to prepare all classes of caivty prior to restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel, dentin, metals and composite surfaces (cavity preparation, orthodontic bands and brackets)
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.
K970589, K974655, K981564, K002708
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
JAN - 9 2004
:
510(k) Summary of Safety and Effectiveness (As Required by 21 C.F.R. §807.92)
| Applicant: | Danville Materials, Inc.
2021 Omega Dr.
San Ramon, CA 94583 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Craig R. Bruns
Phone 925 838-7940
Fax 925 838-0944
e-mail: cbruns@daneng.com |
| Date of summary | September 29, 2003 |
| Device name | PrepAir |
| Common name | Airbrush |
| Classification names | Regulation Number
21 CFR 872.6080 |
| | Product Code
KOJ |
| Device Description | The PrepAir is a dental airbrush using aluminum oxide to prepare all classes of
caivty prior to restoration. |
| Predicate Device | The device is substantially equivalent to other legally marketed devices in the
United States including PrepStart by Danville Engineering (K970589),
PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques
(K981564) and Rondoflex by Kavo America (K002708). |
| Intended Use | The PrepAir is intended for the cutting and preparation of all classes of cavity
restorations; removal of composite resin fillings; surface roughening of
enamel, dentin, metals and composite surfaces prior to adhesive resin bonding;
preparation of pits and fissures prior to sealing; cleaning and removal of
cements and adhesives from bridges and crowns prior to re-cementation; and
preparation of adhesive surfaces of orthodontic bands and brackets to increase
retention. |
ENClosure 3
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 2004
Mr. Craig R. Bruns Danville Materials Incorporated 2021 Omega Road San Ramon, California 94583-1229
Re: K033215
Trade/Device Name: PrepAir Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: KOJ Product Code: II Dated: December 30, 2003 Received: January 2, 2004
Dear Mr. Bruns:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to revea 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 morslate octimers of 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 appear as upportions 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 adultcration.
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 Writ), it may of bund 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.
2
Page 2 -Mr. Bruns
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 yours.
Qre
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
3
Indications for Use
510(k) Number (if known): _K033215
PrepAir Device Name __________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The PrupAir is intended for the cutting and preparation of all classes of cavity The FripAll is intended for the out.its in fillings; surface roughering of enamel, dentin, restorations, removel or composite room Mings, preparation of pits and fieldis and composite ournated provide of cements and adhesives from bridges and crowns prior to re-cementation, and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DI) NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
McCall for MSR
Page 1 of
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: