FDA.report

DD tempMED

Primary DI
EDDIK116151
Brand
DD tempMED
Company
Dental Direkt GmbH
Model
98H15 A1
Catalog number
K11615
Device description
DD tempMED are pre-colored dental milling blanks out of PMMA for the manufacture of temporary crowns and bridges for long-term application in the oral cavity up to 12 months.
Published
2017-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EDDIK116151PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Device Sizes

TypeValueUnit
Height15Millimeter
Outer Diameter98.5Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+495225863190info@dentaldirekt.de

Regulatory Flags

DUNS number
313214171
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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