Product Code: ECN FDA class 1 21 CFR 872.5410

Clamp, Wire, Orthodontic

Dental

The Orthodontic Wire Clamp is a small device used to secure arch wires or auxiliary wires in place on brackets or tubes during orthodontic treatment, preventing slippage of the wire and maintaining the intended mechanical forces. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is ECN and the applicable regulation is 21 CFR 872.5410, under the Dental medical specialty.

510(k)s
0
FEI Numbers
99
Registration Numbers
99
Unique Applicants
0
Years Active

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Basic Information

Product Code
ECN
Device Class
FDA class 1
Regulation Number
872.5410
Medical Specialty
Dental
Review Panel
DE
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 99 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 99 registration numbers. Click on an entry to view related FDA registrations.