FDA.reportPublic FDA data

N.A.

Primary DI
J011100111000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
100-111-00
Device description
Material plates (stainless steel)
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
EJHALLOY, METAL, BASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011100111000PrimaryHIBCC0
J011100111001Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of 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
3
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011302106100tomas®302-106-102016-09-15
J011302106300tomas®302-106-302016-09-15
J011302108100tomas®302-108-102016-09-15
J011302108300tomas®302-108-302016-09-15
J011302110100tomas®302-110-102016-09-15
J011302110300tomas®302-110-302016-09-15
J011302206100tomas®302-206-102016-09-15
J011302206300tomas®302-206-302016-09-15
J011302208100tomas®302-208-102016-09-15
J011302208300tomas®302-208-302016-09-15
J011302210100tomas®302-210-102016-09-15
J011302210300tomas®302-210-302016-09-15
J011790261020equilibrium®790-261-022016-09-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760357974917Prime V Disc 98.5 x13.5 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974924Prime V Disc 98.5 x12 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974931Prime V Disc 98.5 x16 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974948Prime V Disc 98.5 x18 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974955Prime V Disc 98.5 x20 mmBERNARD CERVOS SOCIETEEJH2026-06-09
EYET96300010SOLIBOND N, Ni.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-05-11
EYET96390120Solibond N Alloy Blank (98,5), 12mm, 1 diskYeti Dentalprodukte GmbHEJH2026-05-11
EYET96900010SOLIBOND C plus, Co.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-05-11
EYET6050060M0Bite regist. Metal foil wax, brown,SampleYeti Dentalprodukte GmbHEJH2026-04-16
EYET9600100A0Solidur CoCr Partial Denture Alloys 100gYeti Dentalprodukte GmbHEJH2026-04-16
EYET9630001M0Sample SOLIBOND N, Ni.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-04-16
EYET9690001M0Sample SOLIBOND C plus, Co.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-04-16
EYET9600001M0Sample SOLIDUR CoCr Alloy 30gYeti Dentalprodukte GmbHEJH2026-04-13
06975902950026CoCr Alloy PowderRiton 3D Technology Co., LtdEJH2023-06-04
EBGO505321Mediloy RPDBEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KGEJH2023-05-12
08050612201229Magnum Vip-AMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202103Magnum Saldatura BMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202110Magnum Saldatura CoMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202455Magnum HyperoneMESA DI SALA GIACOMO & C. SNCEJH2020-06-18
08050612202462Magnum HyperoneMESA DI SALA GIACOMO & C. SNCEJH2020-06-18
J011102403890remanium®DENTAURUM GmbH & Co.KGEJH2019-11-20
07630031703088Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703095Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703101Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703118Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703125Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703132Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703149Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703156Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703163Base metal alloyInstitut Straumann AGEJH2019-08-31