FDA 510(k)

DENTAL EQUIPMENT PROTECTION DEVICES

K-Number: K891216 · 1989-06-02

ApplicantPro-Safe Professional Linens, Inc.

Decision Date1989-06-02

Product CodeEAZ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DENTAL EQUIPMENT PROTECTION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Safe Professional Linens, Inc.. It received FDA 510(k) clearance on 1989-06-02 under 510(k) number K891216. The device is classified under product code EAZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL EQUIPMENT PROTECTION DEVICES?

DENTAL EQUIPMENT PROTECTION DEVICES is a medical device that received FDA 510(k) clearance on 1989-06-02. The listed applicant is Pro-Safe Professional Linens, Inc.. The 510(k) number is K891216.

When did DENTAL EQUIPMENT PROTECTION DEVICES receive FDA 510(k) clearance?

DENTAL EQUIPMENT PROTECTION DEVICES received FDA 510(k) clearance on 1989-06-02, under 510(k) number K891216.

Who is the listed applicant for DENTAL EQUIPMENT PROTECTION DEVICES?

The FDA 510(k) record lists Pro-Safe Professional Linens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL EQUIPMENT PROTECTION DEVICES?

The FDA product code for DENTAL EQUIPMENT PROTECTION DEVICES is EAZ.

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Other records listing Pro-Safe Professional Linens, Inc. as applicant

K891210POCKETED WRAPS #3009 A,B,C K891215FAST WRAP #M 101 K891211SURGICAL GOWN #2001 K891212APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE K891213SURGICAL INSTRUMENT POUCH #M102 K891214DENTAL SURGICAL WRAP #3007 A,B,C

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Related Devices (Code: EAZ)

K072309MICROLUX/BLUAddent, Inc.K041614MICROLUX DLAddent, Inc.K033033VIZILITE-BLUE ORAL EXAM KITTrylon Corp.K003995SPECULITE/ORALLITETrylon Corp.K926081DENTAL LIGHTMdt Corp., Inc.K935390SIROLUX FANTASTICPelton & Crane Co.

Official Source

View on FDA Database →

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