FDA.reportPublic FDA data

Evolve

Primary DI
10810152071011
Brand
Evolve
Company
Orthoshop, LLC
Model
6051-18-64
Catalog number
6051-18-64
Device description
Orthodontic Buccal Tubes Evolve MBT .018" Bondable Single Non-Convertible U6R/U6L/L6R/L6L
Published
2023-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZDTube, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152071014PrimaryGS10
10810152071011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152071014008101520710148101520710140810152071014
1081015207101110810152071011

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129808388
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810152070000Mini Maxx S 1011-22-553451011-22-553452023-11-24
00810152070017Mini Maxx S 1011-22-5531011-22-5532023-11-24
00810152070024Mini Maxx S 1011-18-553451011-18-553452023-11-24
00810152070031Mini Maxx S 1011-18-5531011-18-5532023-11-24
00810152070048Lucchesi Sub-Slot2011-22-553452011-22-553452023-11-24
00810152070055ICON 3034-22-5533034-22-5532023-11-24
00810152070062ICON 3034-22-553453034-22-553452023-11-24
00810152070079Mini Maxx S 1011-22-111011-22-112023-11-24
00810152070086Mini Maxx S 1011-22-211011-22-212023-11-24
00810152070093Mini Maxx S 1011-22-121011-22-122023-11-24
00810152070109Mini Maxx S 1011-22-221011-22-222023-11-24
00810152070116Mini Maxx S 1011-22-13H1011-22-13H2023-11-24
00810152070123Mini Maxx S 1011-22-23H1011-22-23H2023-11-24
00810152070130Mini Maxx S 1011-22-14H1011-22-14H2023-11-24
00810152070147Mini Maxx S 1011-22-141011-22-142023-11-24
00810152070154Mini Maxx S 1011-22-24H1011-22-24H2023-11-24
00810152070161Mini Maxx S 1011-22-241011-22-242023-11-24
00810152070178Mini Maxx S 1011-22-15H1011-22-15H2023-11-24
00810152070185Mini Maxx S 1011-22-151011-22-152023-11-24
00810152070192Mini Maxx S 1011-22-25H1011-22-25H2023-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611212702BONDING TUBE PREMIUM ROTH 0.018 - U67R (16/17) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213556BONDING TUBE PREMIUM ROTH 0.018 - U67L (26/27) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213587BONDING TUBE PREMIUM ROTH 0.018 - L67L (36/37) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213839BONDING TUBE PREMIUM ROTH 0.018 - L67R (46/47) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611204264KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2025-04-02
07908611204271KIT ADVANCED METAL BRACKETS MBT 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2025-04-02
10190886052952AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052969AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052976AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052983AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052990AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053003AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053010AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053027AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053034AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053041AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053058AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053065AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053072AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053089AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053096AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053102AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053119AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053126AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053133AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053140AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053157AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053164AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053171AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053188AGILITYG & H Wire Company, Inc.DZD2025-03-27