FDA.reportPublic FDA data

N.A.

Primary DI
J011728510010
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
728-510-01
Device description
Titanium lingual retainer acc. to Kimmich, Length 30 mm
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
EHOBAR, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHOBar, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011728510010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerA dental orthodontic appliance, fixed or removable, used to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. This is a single-patient device that is 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

Sterilization Methods#

Method table
Method

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
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
00190776352066MillenniumAvalign Technologies, Inc.EHO2023-06-23
EZPF41905000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
EZPF41905010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
EZPF4190702S0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
07630031724502NAInstitut Straumann AGEHO2022-11-10
07630031724519NAInstitut Straumann AGEHO2022-11-10
00842092112847HaderPreat CorporationEHO2022-10-24
00842092113103PreatPreat CorporationEHO2022-10-24
00842092129784PreatPreat CorporationEHO2022-10-24
00842092130834PreatPreat CorporationEHO2022-10-24
00842092131923PreatPreat CorporationEHO2022-10-24
00842092133224PreatPreat CorporationEHO2022-10-24
00842092133231PreatPreat CorporationEHO2022-10-24
00842092133330PreatPreat CorporationEHO2022-10-24
00842092133408PreatPreat CorporationEHO2022-10-24
00842092133576PreatPreat CorporationEHO2022-10-24
00842092134450PreatPreat CorporationEHO2022-10-24
00842092134467PreatPreat CorporationEHO2022-10-24
00842092134610PreatPreat CorporationEHO2022-10-24
00842092136522PreatPreat CorporationEHO2022-10-24
00842092139745PreatPreat CorporationEHO2022-10-24
00842092139769PreatPreat CorporationEHO2022-10-24
00842092139783PreatPreat CorporationEHO2022-10-24
00842092139806PreatPreat CorporationEHO2022-10-24
00842092139837PreatPreat CorporationEHO2022-10-24
00842092139851PreatPreat CorporationEHO2022-10-24
00842092139875PreatPreat CorporationEHO2022-10-24
00842092139882PreatPreat CorporationEHO2022-10-24
00842092139905PreatPreat CorporationEHO2022-10-24
00842092139929PreatPreat CorporationEHO2022-10-24