FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040070512
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1060549
Catalog number
1060549
Device description
BALL CLASPS .028 .7mm
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
10304040070519PrimaryGS10
00304040070512Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404007051910304040070519
00304040070512003040400705123040400705120304040070512

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
false
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
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479201399EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201405EXTEND MEASURING DEVICERELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201412EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201429EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201436EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201443EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201450EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00810126381118Nance - Hor RemDigital Dental Laboratories, IncECN2026-02-26
00810126381019Adapt ApplianceDigital Dental Laboratories, IncECN2026-02-25
00810126381026Alf applianceDigital Dental Laboratories, IncECN2026-02-25
00810126381033BiofinisherDigital Dental Laboratories, IncECN2026-02-25
00810126381040Bionator/ActivatorDigital Dental Laboratories, IncECN2026-02-25
00810126381057FraenkelDigital Dental Laboratories, IncECN2026-02-25
00810126381064Habit breaker - removableDigital Dental Laboratories, IncECN2026-02-25
00810126381071HomeoblockDigital Dental Laboratories, IncECN2026-02-25
00810126381088Lingual Arch - Hor remDigital Dental Laboratories, IncECN2026-02-25
00810126381095Lingual Arch - SolderedDigital Dental Laboratories, IncECN2026-02-25
00810126381101Linguarl Arch - Vert RemDigital Dental Laboratories, IncECN2026-02-25
00810126381125Nance - solderedDigital Dental Laboratories, IncECN2026-02-25
00810126381132Nance - Vert RemDigital Dental Laboratories, IncECN2026-02-25
00810126381149OD1Digital Dental Laboratories, IncECN2026-02-25
00810126381156OD2Digital Dental Laboratories, IncECN2026-02-25
00810126381163OD3Digital Dental Laboratories, IncECN2026-02-25
00810126381170OD4Digital Dental Laboratories, IncECN2026-02-25
00810126381187ON1Digital Dental Laboratories, IncECN2026-02-25
00810126381194ON2Digital Dental Laboratories, IncECN2026-02-25
00810126381200ON3Digital Dental Laboratories, IncECN2026-02-25
00810126381217ON4Digital Dental Laboratories, IncECN2026-02-25
00810126381224ON5Digital Dental Laboratories, IncECN2026-02-25
00810126381231PerfectorDigital Dental Laboratories, IncECN2026-02-25