FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT

K Number: K925629 · Decision Nov 23, 1993
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
22
Applicant Total
7
Review Days
382

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Basic Information

Device Name
ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT
K Number
K925629
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.4630
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Den-Tal-Ez Mfg Co., Inc.
Date Received
November 6, 1992
Decision Date
November 23, 1993
Product Code
EAZ
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EAZ Light, Operating, Dental

Similar 510(k) Clearances

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Other Clearances by Den-Tal-Ez Mfg Co., Inc.

K Number Device Name
K932824 EVACUATOR, ORAL CAVITY
K931204 AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)
K920017 IMPROVED DENTAL OPERATING LIGHT
K920016 IMPROVED DENTAL CHAIR
K874294 AUTOCHUCK ATTACHMENT
K780469 PANORAMIC X-RAY, DENTAL