Diamante™ Roth V-Slot Ceramic Brackets 56-U3-8RK-V

by G&H Wire Company, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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	Number10190886005200 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Diamante™ Roth V-Slot Ceramic Brackets
Generic Name: Orthodontic bracket, ceramic
Model / Reference: 56-U3-8RK-V

Primary DI / UDI-DI: 10190886005200
510(k) Number: K132368
FDA Product Code: NJM
GMDN Term: Orthodontic bracket, ceramic

Device Class: Class II
Regulation Number: 872.5470
GUDID distribution status: In Commercial Distribution

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

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

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G&H Orthodontics ® 130-L1-8U-V

Class I

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

Properties

Single Use
Prescription Use
Lot / Batch Number
Manufacturing Date

Other properties (10)

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