FDA.reportPublic FDA data

N.A.

Primary DI
J011003006000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
003-006-00
Device description
Band seater with large surface tin inlay
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECRSETTER, BAND, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECRSetter, Band, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011003006000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal band pusherA hand-held dental instrument intended to be used by an orthodontist for positioning and adapting orthodontic metal bands on teeth. This is a reusable device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011130131000N.A.130-131-002020-08-28
J011130137000N.A.130-137-002020-08-28
J011130138000N.A.130-138-002020-08-28
J011130324000N.A.130-324-002020-08-28
J011130634000N.A.130-634-002020-08-28
J011262411100Carmen®262-411-102016-09-15
J011262412100Carmen®262-412-102016-09-15
J011262415100Carmen®262-415-102016-09-15
J011262421100Carmen®262-421-102016-09-15
J011262422100Carmen®262-422-102016-09-15
J011262423100Carmen®262-423-102016-09-15
J011262424100Carmen®262-424-102016-09-15
J011262431100Carmen®262-431-102016-09-15
J011262432100Carmen®262-432-102016-09-15
J011262433100Carmen®262-433-102016-09-15
J011262434100Carmen®262-434-102016-09-15
J011262442100Carmen®262-442-102016-09-15
J011262443100Carmen®262-443-102016-09-15
J011262444100Carmen®262-444-102016-09-15
J011262450100Carmen®262-450-102016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014476143SmileSet Aligner/Retainer Seater/Removal ToolOrtho Dental Lab LLCECR2025-10-16
00850078989321SmileSet Aligner/Retainer Seater/Removal Tool – 4 PackOrtho Dental Lab LLCECR2025-10-01
00889813063699Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECR2024-11-30
00813677022967PDT, Inc.PDT, INC.ECR2024-07-05
00813677022974PDT, Inc.PDT, INC.ECR2024-07-05
00840326420836Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420843Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420928Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420935Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420942Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420959Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420833Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420840Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420925Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420932Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420949Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420956Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
D1272421031Artman Instruments Wise Linkers, LLCECR2023-03-28
E89656540SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E8965654500SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E896495010SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-06
00817524028805J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00817524028812J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00850007728410ALIGNER SEATER PURPLEAccess Dental Lab, LLCECR2023-02-17
EZPF19080120HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-29
EZPF1926200WL0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-25
00840326408773OrthoquestYoung Innovations, Inc.ECR2022-11-03
00840326408803OrthoquestYoung Innovations, Inc.ECR2022-11-03
10840326408770OrthoquestYoung Innovations, Inc.ECR2022-11-03
10840326408800OrthoquestYoung Innovations, Inc.ECR2022-11-03