FDA.reportPublic FDA data

N.A.

Primary DI
J011850124000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
850-124-00
Device description
Standard Band, Tooth 13/23, Size 11.5
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
J011850124000PrimaryHIBCC0
J011850124001Unit of UseHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-3946info@dentaurum-us.com

Regulatory Flags#

DUNS number
315427286
Device count
10
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
J011102620600remanium®102-620-602026-11-04
J011250321030ceraMotion®250-321-032026-10-23
J011250322030ceraMotion®250-322-032026-10-23
J011250337030ceraMotion®250-337-032026-10-23
J011250338030ceraMotion®250-338-032026-10-23
J011741049000N.A.741-049-002016-09-15
J011302112000tomas®302-112-002026-09-30
J011302114000tomas®302-114-002026-09-30
J011302212000tomas®302-212-002026-09-30
J011302214000tomas®302-214-002026-09-30
J011250301010ceraMotion®250-301-012026-09-25
J011250306010ceraMotion®250-306-012026-09-25
J011254012040ceraMotion®254-012-042026-09-25
J011254014040ceraMotion®254-014-042026-09-25
J011302150000tomas®302-150-002026-09-04
J011302250000tomas®302-250-002026-09-04
J011520120000Noninium®520-120-002026-09-04
J011621040000Noninium®621-040-002026-09-04
J011621404000Noninium®621-404-002026-09-04
J011621407000Noninium®621-407-002026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456206225JMUJMU DENTAL, INCECM2026-06-25
00840456206232JMUJMU DENTAL, INCECM2026-06-25
00190707133207Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
00190707134341Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
00190707140021Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
00190707140366Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
00190707141387Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
00190707141516Band AssembliesOrtho Organizers, Inc.ECM2025-07-07
08033707035015LEONE SPALEONE SPAECM2020-11-10
08033707035022LEONE SPALEONE SPAECM2020-11-10
08033707035039LEONE SPALEONE SPAECM2020-11-10
08033707035046LEONE SPALEONE SPAECM2020-11-10
08033707035053LEONE SPALEONE SPAECM2020-11-10
08033707035060LEONE SPALEONE SPAECM2020-11-10
08033707035077LEONE SPALEONE SPAECM2020-11-10
08033707035084LEONE SPALEONE SPAECM2020-11-10
08033707035091LEONE SPALEONE SPAECM2020-11-10
08033707035107LEONE SPALEONE SPAECM2020-11-10
08033707035114LEONE SPALEONE SPAECM2020-11-10
08033707035121LEONE SPALEONE SPAECM2020-11-10
08033707035138LEONE SPALEONE SPAECM2020-11-10
08033707035145LEONE SPALEONE SPAECM2020-11-10
08033707035152LEONE SPALEONE SPAECM2020-11-10
08033707035169LEONE SPALEONE SPAECM2020-11-10
08033707035176LEONE SPALEONE SPAECM2020-11-10
08033707035183LEONE SPALEONE SPAECM2020-11-10
08033707035190LEONE SPALEONE SPAECM2020-11-10
08033707035206LEONE SPALEONE SPAECM2020-11-10
08033707035213LEONE SPALEONE SPAECM2020-11-10
08033707035220LEONE SPALEONE SPAECM2020-11-10