FDA.reportPublic FDA data

dentaform®

Primary DI
J011845608000
Brand
dentaform®
Company
DENTAURUM GmbH & Co.KG
Model
845-608-00
Device description
dentaform® Bands Lateral Upper left No. 8
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
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
J011845608000PrimaryHIBCC0
J011845608001Unit of UseHIBCC0

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
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011772204020N.A.772-204-022021-03-10
J011254000020ceraMotion®254-000-022026-07-25
J011254000100ceraMotion®254-000-102026-07-25
J011254000500ceraMotion®254-000-502026-07-25
J011254001020ceraMotion®254-001-022026-07-25
J011254001100ceraMotion®254-001-102026-07-25
J011254001500ceraMotion®254-001-502026-07-25
J011254002020ceraMotion®254-002-022026-07-25
J011254002100ceraMotion®254-002-102026-07-25
J011254002500ceraMotion®254-002-502026-07-25
J011254004020ceraMotion®254-004-022026-07-25
J011254004100ceraMotion®254-004-102026-07-25
J011254006020ceraMotion®254-006-022026-07-25
J011254006100ceraMotion®254-006-102026-07-25
J011254008020ceraMotion®254-008-022026-07-25
J011254008100ceraMotion®254-008-102026-07-25
J011254010020ceraMotion®254-010-022026-07-25
J011254010100ceraMotion®254-010-102026-07-25
J011254012020Triceram®254-012-022026-07-25
J011254014020Triceram®254-014-022026-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456206225JMUJMU DENTAL, INCECM2026-06-25
00840456206232JMUJMU DENTAL, INCECM2026-06-25
08033707035763LEONE SPALEONE SPAECM2020-11-11
08033707035770LEONE SPALEONE SPAECM2020-11-11
08033707035787LEONE SPALEONE SPAECM2020-11-11
08033707035794LEONE SPALEONE SPAECM2020-11-11
08033707035800LEONE SPALEONE SPAECM2020-11-11
08033707035817LEONE SPALEONE SPAECM2020-11-11
08033707035824LEONE SPALEONE SPAECM2020-11-11
08033707035831LEONE SPALEONE SPAECM2020-11-11
08033707035848LEONE SPALEONE SPAECM2020-11-11
08033707035855LEONE SPALEONE SPAECM2020-11-11
08033707035862LEONE SPALEONE SPAECM2020-11-11
08033707035879LEONE SPALEONE SPAECM2020-11-11
08033707035886LEONE SPALEONE SPAECM2020-11-11
08033707035893LEONE SPALEONE SPAECM2020-11-11
08033707035909LEONE SPALEONE SPAECM2020-11-11
08033707035916LEONE SPALEONE SPAECM2020-11-11
08033707035923LEONE SPALEONE SPAECM2020-11-11
08033707035930LEONE SPALEONE SPAECM2020-11-11
08033707035947LEONE SPALEONE SPAECM2020-11-11
08033707035954LEONE SPALEONE SPAECM2020-11-11
08033707035961LEONE SPALEONE SPAECM2020-11-11
08033707035978LEONE SPALEONE SPAECM2020-11-11
08033707035985LEONE SPALEONE SPAECM2020-11-11
08033707035992LEONE SPALEONE SPAECM2020-11-11
08033707036005LEONE SPALEONE SPAECM2020-11-11
08033707036012LEONE SPALEONE SPAECM2020-11-11
08033707036029LEONE SPALEONE SPAECM2020-11-11
08033707036036LEONE SPALEONE SPAECM2020-11-11