FDA.reportPublic FDA data

Kit, Pliers Set Detail/Eraser

Primary DI
00816063021506
Brand
Kit, Pliers Set Detail/Eraser
Company
Align Technology, Inc.
Model
76018
Device description
Invisalign Pliers Set (Orthodontic Pliers)
Published
2022-12-06
Public version status
Update
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
JEXPlier, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816063021506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816063021506008160630215068160630215060816063021506

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
013831768
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816063020172Vivera Realine85672016-09-24
00816063023791Cleaning Crystals, Packette2272872026-07-21
00816063020097Realine85542016-09-24
00816063020240The Signature Smile90162017-11-10
00816063020448Invisalign Signature Smile90212018-06-15
00816063020455Invisalign Signature Plus Smile90202018-06-15
00816063020462Invisalign Deluxe Smile90192018-06-15
00816063023029iTero Element™ 5D imaging system2176182026-07-22
00816063022312iTero Lumina Pro DOA2219592026-06-25
00816063021735iTero Element 5D scanning unit, service2069552026-06-23
00816063022169Attachment Template1000122023-07-24
00816063023180Invisalign ART90502026-02-25
00816063023777Invisalign Specifix Attachment System50352026-02-09
00816063023784lnvisalign Specifix Attachment System (include Engagement Features)50362026-02-09
00816063023760Gumlines2267972026-01-01
00816063023173iTero Lumina – PC cfg, Interface Box2176222025-09-16
00816063023197iTero Lumina Software2259692025-09-16
00816063023210iTero Lumina – PC cfg2231122025-09-16
00816063023227iTero Lumina – PC cfg2231102025-09-16
00816063023241iTero Lumina – PC cfg2231112025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791031420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791031430DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050660DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050670DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050680DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050810DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G879105085M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050890DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050980DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050990DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051040DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051390DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G87910513910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051440DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051530DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G87910515910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791052160DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791052280DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791053010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791053020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791053030DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14