FDA.reportPublic FDA data

ICON

Primary DI
00810152070918
Brand
ICON
Company
Orthoshop, LLC
Model
ICONTOOL
Catalog number
ICONTOOL
Device description
ICON Self-Ligating Opening Instrument
Published
2023-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ECPInstrument, Ligature Tucking, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECPInstrument, Ligature Tucking, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152070918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152070918008101520709188101520709180810152070918

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracket open/close toolA hand-held dental instrument intended to be used by an orthodontist for opening/closing a self-ligating orthodontic bracket and/or tube. It is made of metal and is in the form of a handle with thin pronged ends designed to release/close the orthodontic appliance clip mechanism; it may also be used to hold the archwire in place to assist manual closing of the clip. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129808388
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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
G149TBSB1360TBS BASICSACME ENTERPRISE.ECP2026-05-20
G149TBSB1350TBS BASICSACME ENTERPRISE.ECP2026-05-18
00840479203614ULTRA VIOLET MINI LIGHTRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-13
00840479203669SYRINGE WING (1)RELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-13
00840479203270MIXING RESERVOIR RING WELRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203287MIXING RESERVOIR RING WELRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203348SPATULARELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203447SPONGE PELLETRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479202112MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202143MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202150MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202167MIXING ACCESSORY PACKRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479201528SYRINGE WING (1)RELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-05
00840479200576SPATULARELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200583WHITE SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200590LIGHT IMPERVIOUS MIX WELLRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200606SUPERFINE MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200651SPONGE PELLETRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
0084047920070521 GAUGE BRUSH TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200712"4"" BEND A BRUSHES"RELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200729"4"" BEND A BRUSHES"RELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200743ACCESSORY PACKRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200972BRUSH TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200354WHITE MIXING WELLRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200361CLEAR SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200385CLEAR SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200866BRUSH HANDLE ASSORTEDRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479203454SELF MIXING TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
0084047920349215 GAUGE TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479209814SELF MIXING TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20