(8 days)
The Acclaim system is primarily a tool to provide visual information to dental patients so that they can better understand the necessity and quality of the health care they receive.
Not Found
This is a notification about the clearance of the Acclaim system, a dental operative unit, and accessories. Due to the nature of the document, there is no information regarding the acceptance criteria, study details, or device performance as it would be found in a clinical study report. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed devices.
The key information provided is:
- Trade/Device Name: Acclaim
- Regulation Number: 21 CFR 872.6640
- Regulation Name: Dental Operative Unit and Accessories
- Regulatory Class: I
- Product Codes: NRD and EAY
- 510(k) Number: K042266
- Indications for Use: The Acclaim system is primarily a tool to provide visual information to dental patients so they can better understand the necessity and quality of the healthcare they receive. This is the same intended use as previously cleared for the VistaCam Omni IC, 510(k) number K974204.
Since this is a Class I device and a 510(k) clearance, a full clinical study with specific acceptance criteria and detailed performance metrics is often not required, especially if the device is found to be substantially equivalent to a predicate device. The substantial equivalence is typically based on technological characteristics and intended use.
Therefore, I cannot provide the detailed information requested in the prompt based on the provided FDA clearance letter.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Mr. Joseph Carey Director of Quality Assurance Air Techniques, Incorporated 70 Cantiague Rock Road Hicksville, New York 11801
Re: K042266
Trade/Device Name: Acclaim Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Codes: NRD and EA Y Dated: August 02, 2004 Received: August 23, 2004
Dear Mr. Carey:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) promanter is substantially equivalent (for the indications for referenced above and nave acternined the are as a seedicate devices marketed in interstate commerce use stated in the encrosure) to regally manited in Medical Device Amendments, or to devices that prov to May 26, 1770, the onlinent and the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with a premarket approval application (PMA). You may, Act (Act) that do not require approval or a provisions of the Act. The Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good controls provisions of the necessar prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into existing major regulations affecting your device can be may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
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Page 2 - Mr. Joseph Carey
Please be advised that FDA's issuance of a substantial equivalence determination and of the other Please be advised that IDA 's Issualled of a substance of a substition requirements of the Act of that FDA nas made a decemination mat your certer Federal agencies. You must comply with any Federal Statules and regulations administered of two registration and listing (21 CFR Part 877);
all the Act's requirements, including, but not limited to: registration a all the Act s requirements, including, our not increative requirements as set forth in the quality. labeling (21 CFR Part 801); good manatations from the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiat systems (QB) regarations (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 5 10(k) I his letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket nothication. The PDA midnig of succeantal required 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 If you desire spective aurice for your device on our a sudditionally, for questions on the promotion contact the Office of Comphance at (301) 591-1019 1-1012 1-101 594-4639. Also,
and advertising of your device, please contact the Office of Compliance at (301 CTD and advertising of your device, prease connect and or reference to premarket notification's Associa please note the regulation childler, "Misoranania" of responsibilities under the Act may Part 807,97) you thay obtain. Other general infermational and Consumer Assistance at its be obtained from the DFABION or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chun-S. Lin, PhD
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
Page 1 of 1
STATEMENT OF INDICATIONS FOR USE:
| 510K Number (if known): | K042266 |
|---|---|
| Device Name: | Acclaim |
Indications for Use:
The Acclaim system is primarily a tool to provide visual information to dental patients so The Acclaim System is primarily a toe to provincity and quality and quality of the health care they receive.
neath care they room.
This is the same intended use as previously cleared for the Vistacam Omni IC, 510(k) number 974204.
(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 Anesthesiology, General Hospital, Infection Control, Dental Devices | |
|---|---|
| 510(k) Number: | K042266 |
| Prescription Use (Per 21 CFR 801.109) | or Over the counter use ______ |
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.