Product Code: ECP FDA class 1 21 CFR 872.4565

Instrument, Ligature Tucking, Orthodontic

Dental

The Orthodontic Ligature Tucking Instrument is a hand dental instrument used to push and tuck the free ends of ligature wires beneath the arch wire after tying, preventing the wire ends from irritating the patient's oral mucosa. 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 ECP and the applicable regulation is 21 CFR 872.4565, under the Dental medical specialty.

510(k)s
0
FEI Numbers
93
Registration Numbers
93
Unique Applicants
0
Years Active

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Basic Information

Product Code
ECP
Device Class
FDA class 1
Regulation Number
872.4565
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 93 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.