FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040115944
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1067871
Catalog number
1067871
Device description
MOLAR BANDS LOWER LEFT SECOND MOLAR 41
Published
2019-09-17
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
ECMBAND, PREFORMED, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040115944PrimaryGS10
00304040115947Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404011594410304040115944
00304040115947003040401159473040401159470304040115947

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. 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
2
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
00840018667815Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECM2025-11-06
10190707120051TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120068TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120075TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120082TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120099TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120105TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120112TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120129TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120136TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120143TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120150TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120167TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120174TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120181TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120198TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120204TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120211TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120228TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120235TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120242TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120259TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120266TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120273TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120280TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120297TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120303TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120310TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120327TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120334TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17