FDA.report

Baltic Denture System BDLoad

Primary DI
D7091034450
Brand
Baltic Denture System BDLoad
Company
Merz Dental GmbH
Model
BalticDentureSystem BDLoad BDLoad High Impact uppe
Catalog number
1034450
Device description
Baltic Denture System BDLoad BDLoad High Impact upper Mm6 PLSEbim6DFm A3,5light pink
Published
2019-10-01
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

Product Codes

CodeName
EKODenture Preformed (Partially Prefabricated Denture)

Product Code Classifications

CodeDeviceSpecialtyClass
EKODenture Preformed (Partially Prefabricated Denture)Dental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7091034450PrimaryHIBCC0

GMDN Terms

TermDefinition
Preformed complete dentureA prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge; an entire complement of artificial teeth from one arch is added to create a full denture. It is available in several standard sizes that can be contoured to custom fit the patient's ridge.

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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