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

SHIELD, DENTAL X-RAY, PROTECTIVE

K Number: K770407 · Decision Mar 15, 1977
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
0
Applicant Total
4
Review Days
11

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Basic Information

Device Name
SHIELD, DENTAL X-RAY, PROTECTIVE
K Number
K770407
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
892.6500
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Worldwide Dental, Inc.
Date Received
March 4, 1977
Decision Date
March 15, 1977
Product Code
IWO
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

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

Product Code Device Name
IWO Apron, Protective

Other Clearances by Worldwide Dental, Inc.

K Number Device Name
K961472 DENTAL DAM SILICONE
K945077 INSTRUMENT,FILLING,PLASTIC,DENTAL
K940785 MOUTH PROPS