M5 Trueform Thermal Nickel Titanium M5TFL1616ACB

by G&H Wire Company, Inc. 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10190886180945 UDI-DI	Date26 Mar 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: M5 Trueform Thermal Nickel Titanium
Generic Name: Orthodontic archwire
Model / Reference: M5TFL1616ACB

Primary DI / UDI-DI: 10190886180945
FDA Product Code: DZC
GMDN Term: Orthodontic archwire

Device Class: Class I
Regulation Number: 872.5410
GUDID distribution status: In Commercial Distribution

Size: Width — .016 Inch
Height — .016 Inch

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G&H Orthodontics ® 130-U2-8l-V

Class I
G&H Orthodontics ® 130-U3-8RK-V

Class I
G&H Orthodontics ® 130-U3-8LK-V

Class I
G&H Orthodontics ® 130-L1-8U-V

Class I

See all devices from G&H Wire Company, Inc. →

Properties

Single Use
Prescription Use
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (9)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No