(146 days)
The Kreativ Mach Series Air Abrasion systems are used for cavity preparation in Classes I, II, 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. They are also used for restoration prophylaxis.
The Mach 5, Mach 5 plus, Mach 6 are pneumatic devices which combine pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The units are capable of removing dental caries, old restoration 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 handpiece which is approximately the size of a high speed dental drill. The systems are designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.
The provided text describes a 510(k) submission for dental devices (Mach 5, Mach 5 plus, Mach M, and Mach 6) and focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study designed to prove the devices meet specific performance criteria in the way that an AI/ML device submission would.
Therefore, I cannot provide the requested table and study details. The document is a regulatory submission demonstrating substantial equivalence, not a performance study against predefined acceptance criteria for the devices' operational output.
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JUN 1 6 1998
2980214
Regulatory Authority: Safe Medical Devices Act of 1990, CFR 807.87
Company Name:
Kreativ, Inc. 1517 Industrial Way SW Albany, OR 97321
Company Contact, Regulatory Affairs Jeff Lane Kreativ, Inc. 1517 Industrial Way. SW Albany, OR 97321 Phone: 541/924 2480
Device Name:
Mach 5, Mach 5 plus, Mach M, and Mach 6
Predicate Devices:
KV 1, K#940776 (Kreativ, Inc., Albany, OR), KCP 2000, K#921748 (American Dental Technologies, Troy, MI). and the MicroPrep Cavity Preparation System, K#932997, (Sunrise Technologies, Inc.).
Device and Indications for use:
The Mach 5, Mach 5 plus, Mach 6 are pneumatic devices which combine pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations.
The units are capable of removing dental caries, old restoration 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 handpiece which is approximately the size of a high speed dental drill.
The systems are 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 5, Mach 5 plus, Mach M. and the Mach 6 are virtually identical to the predicate devices, and the differences in the devices only make them easier to use and more adaptable to a variety of dental practice situations, we believe that the Mach Series devices are substantially equivalent to the predicate devices and can be marketed under Section 510 (k) of the FD&C Act.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three human profiles facing to the right.
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గా నిర్మాలు
గారా
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1998
Mr. Joe Forehand · Vice President of Operations Kreativ, Incorporated 1517 Industrial Way S.W. Albany, Oregon 97321
Re : K980216 Trade Name: Kreativ Mach 5, Mach 5 Plus, Mach M, and Mach 6 Regulatory Class: III Product Code: KOJ January 19, 1998 Dated: Received: January 21, 1998
Dear Mr. Forehand:
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 Requlations, 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 resulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Forehand
the Act for devices under the Electronic 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 requlation (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 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.fdaygov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulinski
TimothyA. Ulatowski 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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Exhibit 3a
Indications Statement
510(k) submission: Kreativ Mach Series Air Abrasion Systems: Mach 5, Mach 5+, Mach M, and Mach 6
Indications for use:
The Kreativ Mach Series Air Abrasion systems are used for cavity preparation in Classes I, II, 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. They are also used for restoration prophylaxis.
യുടെ
പുറത്തേ
പണ്ട
Susan Runyon
(Division Sign-Off)
vision of Dental, Infection Control, General Hospital Deyic 510(k) Number
.
§ 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.”