FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040070618
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1069386
Catalog number
1069386
Device description
ADAMS CLASPS 9mm
Published
2021-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
ECNCLAMP, WIRE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040070611PrimaryGS10
10304040070618Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040070611003040400706113040400706110304040070611
1030404007061810304040070618

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
100
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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456221730JMUJMU DENTAL, INCECN2026-05-11
00840456221747JMUJMU DENTAL, INCECN2026-05-11
006522210993343M™ Unitek™ Intraoral Attachments3M UNITEK CORPORATIONECN2026-05-07
00190746203770Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203787Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203794Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203800Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203817Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203824Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203831Bondable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
10371347023203Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023210Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023227Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023234Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023241Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023258Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023265Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023272Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023289Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
07908611211644CRIMPABLE BALL HOOK - UNIVERSAL - 2.7MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611211651CRIMPABLE BALL HOOK - UNIVERSAL - 4,0MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611211668BUTTON WITH LONG HOOK FOR BONDING - LEFT - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212603BUTTON WITH LONG HOOK FOR BONDING - RIGHT - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212634ORTHODONTIC SPUR - 50UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212665ORTHODONTIC BITE TURBO - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212672LINGUAL BUTTON PERFORATED BASE FOR BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611213815BUTTON WITH CAPLIN HOOK FOR BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611214928LONG CRIMPABLE HOOK - RECTANGULAR - LEFT - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611214935LONG CRIMPABLE HOOK - RECTANGULAR - RIGHT - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
00190707124267Ortho Technology®Ortho Organizers, Inc.ECN2025-10-17