(83 days)
This new device is a lubricant and is intended for use to lubricate the dental and medical surgical handpieces.
This new device is a lubricant and is intended for use to lubricate the dental and medical surgical handpieces.
I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a dental handpiece lubricant called "Pana-Spray", indicating it is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, intended use, and general controls, but not specific performance criteria or a study proving those criteria are met.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
DEC 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hirohiko Murase General Manager & Vice President NSK America Corporation 700B Cooper Court Schaumburg, Illinois 60173
Re: K052700
Trade/Device Name: Pana-Spray Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: 1 Product Code: EFB Dated: September 26, 2005 Received: September 28, 2005
Dear Mr. Murase:
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 received as a ruse 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 Amendinents, or to are 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 approvisions 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 (1 wr ), it ness 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.
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Page 2 - Mr. Murase
Please be advised that FDA's issuance of a substantial equivalence determination does not I Ticast be advisod that 1221 o to teemination that your device complies with other requirements modi that I DI mas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal the Act's requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF R Part 067), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quartis ion 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) This letter wrification. The FDA finding of substantial equivalence of your device to a premarket notified.rom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not Compliance at (240) 276-0115. 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 may overn of Small Manufacturers, International and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sulfite Y. Michio O. md.
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
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Indications For Use Statement
510(k) Number (if known)
510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
Device Name:
Pana-Spray
Indications For Use:
This new device is a lubricant and is intended for use to lubricate the dental and medical surgical handpieces.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) വ ഔഷധം
പ്രോക്കാരിടെയും Ganeral Hospilud, ംബ Control, Dantal Davices 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.