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
Rx
false
OTC
false
Sterile
false
Single use
false

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
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
10810152070007Mini Maxx S 1011-22-553451011-22-553452023-11-24
10810152070014Mini Maxx S 1011-22-5531011-22-5532023-11-24
10810152070021Mini Maxx S 1011-18-553451011-18-553452023-11-24
10810152070038Mini Maxx S 1011-18-5531011-18-5532023-11-24
10810152070045Lucchesi Sub-Slot2011-22-553452011-22-553452023-11-24
10810152070052ICON 3034-22-5533034-22-5532023-11-24
10810152070069ICON 3034-22-553453034-22-553452023-11-24
10810152070076Mini Maxx S 1011-22-111011-22-112023-11-24
10810152070083Mini Maxx S 1011-22-211011-22-212023-11-24
10810152070090Mini Maxx S 1011-22-121011-22-122023-11-24
10810152070106Mini Maxx S 1011-22-221011-22-222023-11-24
10810152070113Mini Maxx S 1011-22-13H1011-22-13H2023-11-24
10810152070120Mini Maxx S 1011-22-23H1011-22-23H2023-11-24
10810152070137Mini Maxx S 1011-22-14H1011-22-14H2023-11-24
10810152070144Mini Maxx S 1011-22-141011-22-142023-11-24
10810152070151Mini Maxx S 1011-22-24H1011-22-24H2023-11-24
10810152070168Mini Maxx S 1011-22-241011-22-242023-11-24
10810152070175Mini Maxx S 1011-22-15H1011-22-15H2023-11-24
10810152070182Mini Maxx S 1011-22-151011-22-152023-11-24
10810152070199Mini Maxx S 1011-22-25H1011-22-25H2023-11-24

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Primary DI, Brand, Company table
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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
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00840479200606SUPERFINE MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
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008404792007294" BEND A BRUSHESRELIANCE 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
0084047920990615 GAUGE TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
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