FDA.reportPublic FDA data

N.A.

Primary DI
J011831601000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
831-601-00
Device description
Matrix band on rolls, [F] 0.05 x 5.00 mm, Length 1 m, spring hard
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYOBAND, MATERIAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYOBand, Material, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011831601000PrimaryHIBCC0

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.

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
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011250001400ceraMotion®250-001-402016-09-15
J011250002200ceraMotion®250-002-202016-09-15
J011250002400ceraMotion®250-002-402016-09-15
J011250003200ceraMotion®250-003-202016-09-15
J011250003400ceraMotion®250-003-402016-09-15
J011250004200ceraMotion®250-004-202016-09-15
J011250004400ceraMotion®250-004-402016-09-15
J011250005200ceraMotion®250-005-202016-09-15
J011250005400ceraMotion®250-005-402016-09-15
J011250006200ceraMotion®250-006-202016-09-15
J011250006400ceraMotion®250-006-402016-09-15
J011250018200ceraMotion®250-018-202016-09-15
J011250019200ceraMotion®250-019-202016-09-15
J011250021200ceraMotion®250-021-202016-09-15
J011250021400ceraMotion®250-021-402016-09-15
J011250022200ceraMotion®250-022-202016-09-15
J011250022400ceraMotion®250-022-402016-09-15
J011250023200ceraMotion®250-023-202016-09-15
J011250023400ceraMotion®250-023-402016-09-15
J011250024200ceraMotion®250-024-202016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974720061198Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061204Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061211Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061228Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061235Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061242Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
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006522213031963M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032023M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032193M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032263M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-25