FDA.report

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Primary DI
ENTTMEG5DIM3551
Brand
-
Company
NT-Trading GmbH & Co. KG
Model
MEG 5.DIM.355
Catalog number
MEG 5.DIM.355
Device description
DIM Analog
Published
2023-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ENTTMEG5DIM3551PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497219619990xx@xx.xx

Regulatory Flags

DUNS number
312800478
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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ENTTBEG9S3D41001-BEG 9.S3D4.100BEG 9.S3D4.1002023-07-21
ENTTBEG9S3D45001-BEG 9.S3D4.500BEG 9.S3D4.5002023-07-21
ENTTBEG9S3D55001-BEG 9.S3D5.500BEG 9.S3D5.5002023-07-21
ENTTBEGTR0001321-BEG TR-00013.2BEG TR-00013.22023-07-21
ENTTBEGTR00024211-BEG TR-00024.2BEG TR-00024.22023-07-21
ENTTBEGTR0003451-BEG TR-00034.5BEG TR-00034.52023-07-21
ENTTBEGTR0004551-BEG TR-00045.5BEG TR-00045.52023-07-21
ENTTBIO5LA30001-BIO 5.LA3.000BIO 5.LA3.0002023-07-21
ENTTBIO5LA35001-BIO 5.LA3.500BIO 5.LA3.5002023-07-21
ENTTBIO5LA45001-BIO 5.LA4.500BIO 5.LA4.5002023-07-21
ENTTBIO5LA57001-BIO 5.LA5.700BIO 5.LA5.7002023-07-21
ENTTBIO9S3D30001-BIO 9.S3D3.000BIO 9.S3D3.0002023-07-21
ENTTBIO9S3D35001-BIO 9.S3D3.500BIO 9.S3D3.5002023-07-21
ENTTBIO9S3D45001-BIO 9.S3D4.500BIO 9.S3D4.5002023-07-21

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