FDA.reportPublic FDA data

rematitan®

Primary DI
J011240012000
Brand
rematitan®
Company
DENTAURUM GmbH & Co.KG
Model
240-012-00
Device description
rematitan® attachment, 90 °, complete Ti-plastic female part
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
EBLPIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBLPin, Retentive And Splinting, And Accessory InstrumentsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011240012000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sliding dental precision attachmentA device designed used for the fixation of a dental prosthesis where the male part slides into a precision groove in the female part.

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

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Primary DI, Brand, Company table
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00810060225998Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226001Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226018Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226025Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226032Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
08800075620965OSUNG MNDOSUNG MND Co., Ltd.EBL2024-03-06
08800075620972OSUNG MNDOSUNG MND Co., Ltd.EBL2024-03-06
00810060225721Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2023-11-09
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