Pana-Spray

FDA 510(k) K052700 · Nsk America Corp.

Substantially Equivalent

510(k) numberK052700

Submission

Device name
Pana-Spray
Applicant
Nsk America Corp.
Schaumburg, IL, US
Received
September 28, 2005
Decision date
December 20, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EFB – Handpiece, Air-Powered, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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More from Ttbio Corp.

510(k)DeviceDecision
K131014Pana Spray PlusEFB · Traditional 08/12/2013SE

Questions and answers

When was Pana-Spray cleared by the FDA?

Pana-Spray (K052700) received a 510(k) decision of Substantially Equivalent on December 20, 2005, 83 days after the submission was received.

What is the product code of K052700?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.