FDA.report

PremEco Line set-up wax, 500g

Primary DI
D7091030071
Brand
PremEco Line set-up wax, 500g
Company
Merz Dental GmbH
Model
PremEco Line set-up wax, 500g
Catalog number
1030071
Device description
PremEco Line set-up wax, 500g
Published
2020-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
D7091030071PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental casting waxA waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the "lost-wax" casting technique. After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
+494381403411claudia.bobrowski@merz-dental.de

Regulatory Flags

DUNS number
324914910
Device count
1
DM exempt
false
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
false

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