(524 days)
Not Found
No
The description focuses on the mechanical function of an air abrasion system and does not mention any AI/ML components or capabilities.
Yes
The device is used for "cavity preparation" and "removal of tooth structure and restorative dental materials," which are therapeutic dental procedures.
No
Explanation: The device description and intended use clearly state that the Mach 7 Air Abrasion system is used for "cavity preparation," "removal of tooth structure and restorative dental materials," and "site preparation for pit and fissure sealant therapy and bonding." These are all therapeutic and restorative procedures, not diagnostic ones. The device is designed to treat or prepare, not to identify or assess a condition.
No
The device description clearly states it is a "pneumatic device" that combines "pressurized air and aluminum oxide powder" and includes a "hand piece," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Kreativ Mach 7 Air Abrasion system is a dental device used for mechanical procedures on the tooth itself (cavity preparation, material removal, surface preparation). It does not analyze samples taken from the body.
The description clearly indicates it's a tool for performing physical procedures within the mouth, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Mach 7 is an air abrasion pneumatic device which combines pressurized air and aluminum oxide powder to product a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations.
The unit is capable of removing dental caries, old restorative materials as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small hand piece which is approximately the size of a high speed dental drill.
The Kreativ Mach 7 Air Abrasion system is used for cavity preparation in Classes I, III, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. It may also be used for restoration prophylaxis.
Product codes
KOJ
Device Description
The Mach 7 is an air abrasion pneumatic device which combines pressurized air and aluminum oxide powder to product a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations.
The unit is capable of removing dental caries, old restorative materials as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small hand piece which is approximately the size of a high speed dental drill.
The system is designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental practice
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)
Reference Device(s)
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
JUN 1 5 2000
510K Summary
K 990000
Regulatory Authority: Safe Medical Devices Act of 1990. CFR 807.87
Company Name:
Krcativ, Inc. 9025 Balboa Ave. San Diego, CA. 92123
Company Contact:
Joe Forehand Kreativ, Inc. 9025 Balboa Ave. San Diego, CA. 92123 (619) 514-4235
Device Name:
Mach 7
Predicate Devices:
| KCP 2000 | K921748 | American Dental Technologies |
|---|---|---|
| MicroPrep | K932997 | Sunrise Technologies |
| Mach 5 | K980216 | Kreativ, Inc. |
| Mach 6 | K980216 | Kreativ, Inc. |
Device and indications for use:
The Mach 7 is an air abrasion pneumatic device which combines pressurized air and aluminum oxide powder to product a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations.
The unit is capable of removing dental caries, old restorative materials as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small hand piece which is approximately the size of a high speed dental drill.
The system is designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.
Discussion:
Since the intended use and technical specifications of the Mach 7 are virtually identical to the predicate devices and the differences in the device only make it easier to use, more reliable and more adaptable to a variety of dental practice situations, we believe that the Mach 7 is substantially equivalent to the predicate devices and can be marketed under Section 510 (k) of the FD&C Act.
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 5 2000
Mr. Joseph M. Forehand Vice President and General Manager Kreativ, Incorporated 9025 Balboa Avenue San Diego, California 92123-1509
K990060 Re : Trade Name: Mach 7 Requlatory Class: II Product Code: KOJ January 8, 1999 Dated: Received: January 8, 1999
Dear Mr. Forehand:
This letter corrects our substantially equivalent letter of June 15, 2000, regarding the Regulatory Class.
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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against mishranding 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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
2
Page 2 - Mr. Forehand
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 53. through 542 of the Act for devices under the Rlectronic Product Radiation Control provisions, or other Federal laws or regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in Vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely,
Susan Renner
Timothy A. Ulatowski
Director
Division of Dental, Infection Control
and General Hospital Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
3
Indications Statement
510(k) Number:
Device Name: Mach 7
Indication for Use:
The Kreativ Mach 7 Air Abrasion system is used for cavity preparation in Classes I, III, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. It may also be used for restoration prophylaxis.
(Please do not write below this line-continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over the Counter Use_
Optional Format 1-2-96
Quentin Humphrey
MD, PhD
(Division Sign-Off) Division of Dental, Infection : ontrol. and General Hospital Devices 14991 510(k) Number _