LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS
- Primary DI
- 10190886000946
- Brand
- LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS
- Company
- G & H Wire Company, Inc.
- Model
- 40-U1-2R-V
- Device description
- LUCENT™ ROTH .022 UR1 +12°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 |
|---|---|
| DYW | Bracket, Plastic, Orthodontic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DYW | Bracket, Plastic, Orthodontic | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K973776 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10190886000946 | Primary | GS1 | 0 | |
| 00190886000949 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10190886000946 | 10190886000946 | ||
| 00190886000949 | 00190886000949 | 190886000949 | 0190886000949 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthodontic bracket, plastic, single-use | A 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 | |
|---|---|
| +1 317-346-6655 | orders@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 | Catalog | Published |
|---|---|---|---|---|
| 10190886271612 | G&H ORTHODONTICS ® | 131-L5-8RK-V | 2026-02-27 | |
| 10190886271629 | G&H ORTHODONTICS ® | 131-L5-8LK-V | 2026-02-27 | |
| 10190886271841 | G&H ORTHODONTICS ® | 131-L5-2RK-V | 2026-02-27 | |
| 10190886271858 | G&H ORTHODONTICS ® | 131-L5-2LK-V | 2026-02-27 | |
| 10190886271025 | G&H ORTHODONTICS ® | 130-U1-8R-V | 2026-02-27 | |
| 10190886271032 | G&H ORTHODONTICS ® | 130-U1-8L-V | 2026-02-27 | |
| 10190886271049 | G&H ORTHODONTICS ® | 130-U2-8R-V | 2026-02-27 | |
| 10190886271056 | G&H ORTHODONTICS ® | 130-U2-8L-V | 2026-02-27 | |
| 10190886271063 | G&H ORTHODONTICS ® | 130-U3-8RK-V | 2026-02-27 | |
| 10190886271070 | G&H ORTHODONTICS ® | 130-U3-8LK-V | 2026-02-27 | |
| 10190886271087 | G&H ORTHODONTICS ® | 130-U4-8RK-V | 2026-02-27 | |
| 10190886271094 | G&H ORTHODONTICS ® | 130-U4-8LK-V | 2026-02-27 | |
| 10190886271100 | G&H ORTHODONTICS ® | 130-U4-8U-V | 2026-02-27 | |
| 10190886271117 | G&H ORTHODONTICS ® | 130-L1-8U-V | 2026-02-27 | |
| 10190886271124 | G&H ORTHODONTICS ® | 130-L3-8RK-V | 2026-02-27 | |
| 10190886271131 | G&H ORTHODONTICS ® | 130-L3-8LK-V | 2026-02-27 | |
| 10190886271148 | G&H ORTHODONTICS ® | 130-L4-8U-V | 2026-02-27 | |
| 10190886271155 | G&H ORTHODONTICS ® | 130-L4-8RK-V | 2026-02-27 | |
| 10190886271162 | G&H ORTHODONTICS ® | 130-L4-8LK-V | 2026-02-27 | |
| 10190886271179 | G&H ORTHODONTICS ® | 130-L5-8U-V | 2026-02-27 |
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