PANA-SPRAY

K052700 · Nsk America Corp. · EFB · Dec 20, 2005 · Dental

Device Facts

• Record ID: K052700
• Device Name: PANA-SPRAY
• Applicant: Nsk America Corp.
• Product Code: EFB · Dental
• Decision Date: Dec 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

This new device is a lubricant and is intended for use to lubricate the dental and medical surgical handpieces.

Device Story

Pana-Spray is a lubricant product designed for maintenance of dental and medical surgical handpieces. It functions as a mechanical maintenance aid to ensure proper operation of handpiece components. Used in clinical or dental office settings by professional staff. The device is applied to handpieces to reduce friction and wear, thereby extending device life and ensuring consistent performance during medical or dental procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lubricant spray for dental and medical surgical handpieces. Class I device, product code EFB.

Indications for Use

Indicated for lubrication of dental and medical surgical handpieces.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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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