FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040128272
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9007667
Catalog number
9007667
Device description
Maxima Adhesive Remover-1/4 Replacement Pads
Published
2020-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
JEXPLIER, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040128272PrimaryGS10
00304040128275Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404012827210304040128272
00304040128275003040401282753040401282750304040128275

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance system, adjustableAn assembly of devices such as metal bands, archwires, springs and/or power arms, designed to influence the shape and/or function of the stomatognathic system. Once applied to the teeth, it may be periodically adjusted to effect skeletal and/or dental changes by modifying and utilizing the neuromuscular forces of the stomatognathic system. It is typically used to correct malocclusions such as underbites, overbites, and cross bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. Commonly known as a dental brace or orthodontic brace, it 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
012430880
Device count
6
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05
10304040194307Henry Schein570570757057072026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791050070DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-09-30
G8791052360DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-09-30
04963931274673NAYDM CORPORATIONJEX2026-09-25
04963931274680NAYDM CORPORATIONJEX2026-09-25
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