Phase Change Dental Lubricant

FDA 510(k) K954991 · Phase Change

Substantially Equivalent

510(k) numberK954991

Submission

Device name
Phase Change Dental Lubricant
Applicant
Phase Change
Scottsdale, AZ, US
Received
October 31, 1995
Decision date
January 4, 1996
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

Other 510(k)s with product code EFB

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K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional Nakanishi, Inc.04/25/2024SE
K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional Foshan Coxo Medical Instrument Co., Ltd.09/22/2023SE
K232243EVO 700 series high speed handpieceEFB · Special Ttbio Corp.08/23/2023SE

Questions and answers

When was Phase Change Dental Lubricant cleared by the FDA?

Phase Change Dental Lubricant (K954991) received a 510(k) decision of Substantially Equivalent on January 4, 1996, 65 days after the submission was received.

What is the product code of K954991?

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