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Lucent™ Roth Metal Lined Composite Brackets

FDA UDI

Class II (US FDA UDI)

by G&H Wire Company, Inc.

Identity

Trade Name
LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS FDA UDI
Generic Name
Orthodontic bracket, plastic, single-use FDA UDI
Device Name
LUCENT™ ROTH .018 UR3 HK 0°T +11°A Lucent™ composite brackets feature a nickel-free silver alloy-lined archwire slot that makes them a safe alternative for nickel sensitive patients. The metal liner is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets. Lucent™ brackets feature a distinctively designed mushroom grooved base for increased surface contact, allowing for excellent adhesion. The brackets are designed with a porous coating that provides millions of additional undercuts that firmly grip the adhesive. As a result, additional primer agents are not required to bond Lucent™ brackets to the tooth's enamel. Lucent™ brackets feature superior retention and easy debonding characteristics. FDA UDI
Model / Reference
40-U3-8RK-V FDA UDI
Description
LUCENT™ ROTH .018 UR3 HK 0°T +11°A Lucent™ composite brackets feature a nickel-free silver alloy-lined archwire slot that makes them a safe alternative for nickel sensitive patients. The metal liner is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The special composite formulation from which the device is manufactured produces a bracket that displays a high tensile strength. The result is a strong polyurethane bracket with superior sliding mechanics that are equal to or greater than stainless steel brackets. Lucent™ brackets feature a distinctively designed mushroom grooved base for increased surface contact, allowing for excellent adhesion. The brackets are designed with a porous coating that provides millions of additional undercuts that firmly grip the adhesive. As a result, additional primer agents are not required to bond Lucent™ brackets to the tooth's enamel. Lucent™ brackets feature superior retention and easy debonding characteristics. FDA UDI

Identifiers

Primary DI / UDI-DI
10190886001080 FDA UDI
510(k) Number
K973776 FDA UDI
FDA Product Code
DYW FDA UDI
GMDN Term
Orthodontic bracket, plastic, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5470 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic bracket, plastic, single-use

Lucent™ Roth Metal Lined Composite Brackets by G&H Wire Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket, plastic, single-use.

Cleared under the same submission

K973776 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
G&H Wire Company, Inc.

Sources (1)

  • FDA UDI 2bc8e138-c91e-4ef6-82bd-93a320dd24a0 35 fields · synced Jun 8, 2026