LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS

Primary DI
10190886000786
Brand
LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS
Company
G & H Wire Company, Inc.
Model
40-L3-2LK-V
Device description
LUCENT™ ROTH .022 LL3 HK -11°T +5°ALucent™ 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.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYWBracket, Plastic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973776000REFLECTIONSCdb Corp.1997-11-21DYW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190886000786PrimaryGS10
00190886000789Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019088600078610190886000786
00190886000789001908860007891908860007890190886000789

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, plastic, single-useA plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
+1 317-346-6655orders@ghortho.com

Regulatory Flags#

DUNS number
831465641
Device count
5
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190886271612G&H ORTHODONTICS ®131-L5-8RK-V2026-02-27
10190886271629G&H ORTHODONTICS ®131-L5-8LK-V2026-02-27
10190886271841G&H ORTHODONTICS ®131-L5-2RK-V2026-02-27
10190886271858G&H ORTHODONTICS ®131-L5-2LK-V2026-02-27
10190886271025G&H ORTHODONTICS ®130-U1-8R-V2026-02-27
10190886271032G&H ORTHODONTICS ®130-U1-8L-V2026-02-27
10190886271049G&H ORTHODONTICS ®130-U2-8R-V2026-02-27
10190886271056G&H ORTHODONTICS ®130-U2-8L-V2026-02-27
10190886271063G&H ORTHODONTICS ®130-U3-8RK-V2026-02-27
10190886271070G&H ORTHODONTICS ®130-U3-8LK-V2026-02-27
10190886271087G&H ORTHODONTICS ®130-U4-8RK-V2026-02-27
10190886271094G&H ORTHODONTICS ®130-U4-8LK-V2026-02-27
10190886271100G&H ORTHODONTICS ®130-U4-8U-V2026-02-27
10190886271117G&H ORTHODONTICS ®130-L1-8U-V2026-02-27
10190886271124G&H ORTHODONTICS ®130-L3-8RK-V2026-02-27
10190886271131G&H ORTHODONTICS ®130-L3-8LK-V2026-02-27
10190886271148G&H ORTHODONTICS ®130-L4-8U-V2026-02-27
10190886271155G&H ORTHODONTICS ®130-L4-8RK-V2026-02-27
10190886271162G&H ORTHODONTICS ®130-L4-8LK-V2026-02-27
10190886271179G&H ORTHODONTICS ®130-L5-8U-V2026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10190886000748Bite-BumperG & H Wire Company, Inc.DYW2016-09-28
10190886000755LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000762LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000779LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000793LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000809LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000816LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000823LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000830LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000847LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000854LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000861LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000878LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000885LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000892LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000908LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000915LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000922LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000939LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000946LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
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10190886000960LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886000977LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
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10190886001011LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886001028LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886001035LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24
10190886001042LUCENT™ ROTH METAL LINED COMPOSITE BRACKETSG & H Wire Company, Inc.DYW2016-09-24