FDA.report

Structur 2

Primary DI
E22114911
Brand
Structur 2
Company
VOCO GmbH
Model
1491
Catalog number
1491
Published
2016-08-31
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
false

Related Records

Contact Domains

Product Codes

CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E22114911PrimaryHIBCC0
E22114910Unit of UseHIBCC0

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)].

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius23 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags

DUNS number
316699578
Device count
5
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
false
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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E22162841GrandioSO 4U628462842025-06-02
E22162851GrandioSO 4U628562852025-06-02
E22162861GrandioSO 4U628662862025-06-02
E22162871GrandioSO 4U628762872025-06-02
E22162881GrandioSO 4U628862882025-06-02
E22162891GrandioSO 4U628962892025-06-02
E22162901GrandioSO 4U629062902025-06-02
E22162951GrandioSO 4U629562952025-06-02
E22162961GrandioSO 4U629662962025-06-02
E22162971GrandioSO 4U629762972025-06-02
E22162981GrandioSO 4U629862982025-06-02
E22162991GrandioSO 4U629962992025-06-02

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