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FDA 510(k)

PHASE CHANGE DENTAL LUBRICANT

K-Number: K954991 · 1996-01-04

ApplicantPhase Change
Decision Date1996-01-04
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHASE CHANGE DENTAL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Phase Change. It received FDA 510(k) clearance on 1996-01-04 under 510(k) number K954991. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHASE CHANGE DENTAL LUBRICANT?

PHASE CHANGE DENTAL LUBRICANT is a medical device that received FDA 510(k) clearance on 1996-01-04. The listed applicant is Phase Change. The 510(k) number is K954991.

When did PHASE CHANGE DENTAL LUBRICANT receive FDA 510(k) clearance?

PHASE CHANGE DENTAL LUBRICANT received FDA 510(k) clearance on 1996-01-04, under 510(k) number K954991.

Who is the listed applicant for PHASE CHANGE DENTAL LUBRICANT?

The FDA 510(k) record lists Phase Change as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHASE CHANGE DENTAL LUBRICANT?

The FDA product code for PHASE CHANGE DENTAL LUBRICANT is EFB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EFB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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